Guidelines on how to conduct modern day human pathogenetic trials based on directions given by ECH

Guidelines on how to conduct modern day human pathogenetic trials based on directions given by European Committee of Homoeopathy (subcommittee on drug provings) – How homoeopathic medicines are prepared 

Dr.Anand.P.R, B.H.M.S, M.D,M.C.A, M.B.A 

ABSTRACT: At  present there are certain directions as regards to Human Pathogenetic Trials (HPT), but there are no standard procedures delineated. This articles aims to standardize the selection, proving protocols and methodology of Human Drug Provings.

KEYWORDS: Human Pathogenetic Trial (HPT), Hahnemanean Drug Proving.

The European Committee of Homoeopathy (Sub committee on Drug Provings has given the following directions regarding the procedure of drug proving to be followed in homoeopathy.

1. Qualification of the providing doctor : ^{(3, 9)}
   1. Minimum 5 years experience in homoeopathic practice
   2. To have personally proved minimum of 3 remedies (as a volunteer)
2. Case taking (before pre-observation phase) , case taking is obligatory : ⁽³⁾
   • For the safety of the volunteer, to make sure that they are healthy enough to take part in a proving.

1. To give a baseline of the actual of the actual state of health and symptoms.

• To make sure that the volunteer has properly understood the purpose and procedure of the proving, is reliable (§ 126 – organon) and is able to express their symptoms precisely enough.

3. Inclusion Criteria ^{(3, 9)} : The volunteers must be healthy in the sense that they do not show severe psychic or physical symptoms and do not consider themselves to be in need of medical treatment. The proving doctor should not see in necessity for treatment either.
4. Exclusion Criteria ^{(3, 9)}: Pregnancy, breastfeeding, allopathic treatments or homoeopathic drugs, contraceptive pills (intrauterine pessaries, often contain cuprum, etc.)
5. Pre-observation period ^{(3, 9)}: not less than 1 week before intake of the remedy, with recording of symptoms occurring during that time.
6. Drug administration^{(3, 9)} :
   1. Definition of the remedy: Origin and identification, way of manufacturing (e.g. fresh plants, trituration or mother tincture, way of potentisation, solvent etc.)
   2. Dosage and potency: Normally 12C or 30C, 3 globules every 2 hours, as long as no symptoms occur, maximum 6 times, during one day, stop drug intake immediately if symptoms occur.
7. Documentation of symptoms^{(3, 9)}:
   1. Duration of observation of symptoms: Minimum of 4 weeks.
   2. Supervision: Intense contact between proving doctor and volunteer has to be secured i.e., daily phone calls, schedule of meetings.
   3. Symptoms should include location, sensation , modalities (with regard to time also), concomitants, and chronological records (illustrating how long after the commencement of the proving each symptom arose) and should be presented following the head to foot scheme, in distinct categories:
      1. New symptoms
      2. Old symptoms

• Altered symptoms

1. Cured symptoms

Complete original notes should be kept from each volunteer and proving doctor.

8. The legal requirements of the country must be considered. ^{(3, 9)}

Now we will explore the practical aspect of human drug proving experiment which is to be followed in each and every proving.

The drug to be proved. ⁽¹⁰⁾
The first object is to procure the drug or other matter to be proved in its purity; then to make a full statement as to how and where it is to be obtained and how it is to be prepared. The preparation of chemical substances is to be always given in detail by Hahnemann, so as to insure the reproduction of precisely the same chemical substance in the future. Plants should be collected by the prover, if possible, at the right season and where they grow on their original soil; for instance, the flower taken from the Cactus grandiflorus growing in a hot-house, will not make a good preparation, either for provings or as a curative agent. This preparation should be made, as it is to be made, on the spot where the Cactus grows wild, and at the right time and season, when the flower opens at night and fills the atmosphere with its fragrance. ⁽¹⁰⁾

If the drug is taken from the animal kingdom, the animal should, if possible, be preserved and subsequent supplies should come from the same species, and under similar circumstances. ⁽¹⁰⁾

The few drops of poison taken from the Trigonocephalus Lachesis by Dr. Hering, in Surinam, over fifty years ago, has sufficed so far to supply all the demand for Lachesis. What is more, the identical snake from which the poison is to be taken is still preserved in the Academy of Natural Sciences of Philadelphia. Preparations taken from the same species of snake, while confined in cages in menageries or any public institutions, cannot reasonably be expected to have the same medicinal power as those from the wild snake brought alive to Dr. Hering by the Indians in the country where it is to be caught. ⁽¹⁰⁾

THE DOSE⁽¹⁰⁾
We know that one contact with an infectious disease, one inhalation of malarious air, one sudden mental emotion, will cause a succession of phenomena and symptoms, which finally end either in a full recovery, by what is termed the crisis or throwing off of the diseased organism; or else, if the organism be in too feeble a condition to resist the influences, or if the efforts of Nature to bring about this crisis have been interfered with by violent means. (i. e. energetic treatment), the system succumbs to the overpowering influences, and death is the consequence.

This observation of the natural causes of natural diseases must serve us as a guide in ascertaining the sickness properties of drugs. If we wish to ascertain the artificially diseased condition drugs produce upon the healthy, we make our experiment by taking one dose of the drug; and as we do not expect an immediate effect from a contact with all infectious disease experience teaches us that it requires days, hardly ever less than three days before the effects of such a contact become perceptibly developed, so we cannot reasonably expect an immediate perceptible development of Life sick-making effects of one dose of the medicine to be proved. If there is no effect perceptible after, say five days, we will have to proceed just as we do when we administer medicines for the cure of the sick; finding ourselves not susceptible to the drug to be proven, we must take either a lower or higher preparation; and when no effects follow this, we may take the potentized drug in a watery solution until an effect is perceptible. When the question arises what preparation of the drug we should take in that one first dose, we may as well consult Hahnemann, who tells us, in paragraph 128 of his Organon, that substances, if proved in the crude state, by no means show the richness and fullness of sick-making powers; that the dormant powers of the drug are developed by potentization; and that we obtain a better knowledge of the properties of drugs if we take it a few pellets of the 30^th potency. Fifty years ago, the 30^th potency is to be the highest potency known, since then innumerable experiments, both on the healthy and the sick, have fully established the fact that a greater degree of sick-making power is developed by much higher potentizations. When Hahnemann advised a few pellets of the 30^th potency as a proper dose for testing the drug, knowing that its medicinal powers are developed by potentization, his followers tried the experiment, and ascertained that the highest known potencies are endowed with a proportionately higher medicinal property than the crude substances or lower preparations possess. All depends upon the only reliable test, experiment; whoever will make this experiment honestly, will find that a single dose of the highest potency will cause a succession of symptoms much more distinctly marked, much more characteristic than any other preparations before used, even in the single dose or in repeated doses. We have, for instance, this day, no other provings of Theridion than those made by the 30^th potency, we have provings of Lachnanthes made by the highest potency than known (76m.) and the symptoms obtained in this manner have been confirmed by clinical experiment. ⁽¹⁰⁾

DIRECTIONS FOR PREPARATION OF THE DRUG

PURPOSE OF MODERN METHOD:

It is to be noted that tinctures must be of uniform strength. The respective strength    varies greatly due to the “variability” of water contained in the same plant at different seasons   and conditions of growth, procurement, time & shortage. The variability of water content in the solvent especially alcohol, also adds to the variability cause great uncertainty in strengths of tinctures and their dilutions. As such the modern method has evolved ways for securing uniformity in strength or drug power.

In short, the “dry crude drug” has been made the unit from which to estimate the drug strength in all tinctures and triturations.

For vegetable drugs follow the following method:

PLANT   MOISTURE: ^{(1, 2, 4, 5, 6, 7, 8, 11)}

It is the juice contained in the plant.

The purpose of calculating the moisture content:

The drug strength of Q varies greatly due to “variability” of   moisture contained in same plant at different seasons, conditions of growth, procurement, time and storage. As such, moisture content or water content of each crude sample is ascertained before hand.

Calculation of plant moisture :

1. The drug substance is at first kept on the chopping board and cut into different sizes with chopping knife.
2. The chopped drug substance weighed and weight is recorded. The weight of empty porcelain crucible is taken.
3. Then these pieces of drug substance are placed on a crucible, which is then placed on a water bath, so that by the gentle heat of the water bath the juice of the plant is evaporated.
4. The chopped substance should be kept on a water bath until the weight scale shows no reduction of weight.
5. The substance is weighed after every 15 minutes after cooling for a minute until a constant weight is obtained.
6. On obtaining a constant weight, which means there is no more water vapour is left.
7. Now comparing the final weight with that which is taken before will give the amount of moisture content of the drug substance.

After determining   how   much quantity of dry substance is present in given quantity of fresh moist materials, this is to be compared with respective tincture formula. For this drug as specified in the pharmacopoeia if it’s weight falls below, (the standard weight of particular formula) sufficient quantity of purified water is added equalize with the standard weight. But if the weight is different from that prescribed as the standard weight of the particular formula for preparation of a particular drug then deduct sufficient quantity of purified water (cautious evaporating in moderate temperature) required to be mixed with strong alcohol to make it equal with the standard formula.

PROCEDURE: ^{(1, 2, 4, 5, 6, 7, 8, 11)}

1. Pre process: Moisture content of the drug substances (i.e. excess or deficiency of water) is calculated with the help of the water-bath. 

1. Process- proper.

1. The drug – substances are made a pulp(magma) ,(or in its natural state   if not  reducible )

2. The pulp (magma) is placed in a macerating jar, preferable made of glass or stainless   steel

3. Prescribed quantity of alcohol (pre –calculated) is added to cover the whole mass of drug substances.

4. The macerating jar is now carefully corked or sealed in order to prevent the evaporation of the menstrum (alcohol)

5. The jar is kept in a cool dark place, free from dust, odour, heat or direct sunlight. The temperature is better within the range of 15 C – 20 C. The jar is kept for 2-4 weeks. [According to nature of material] and is shaken everyday.

NOTE: The   time necessary for the extraction and   solution of medicinal substance is variable, and it is safe to allow the process of maceration to continue from two to four weeks.

6. After this period, the clear liquid above is decanted off and the residue can be pressed out through a piece of linen cloth or bag, adding more of prescribed menstrum if necessary to make the required volume.

7. In case of viscid and mucilaginous drug-material which is not readily acted on by alcohol, only  one half of  the  solvent  prepared    for the   purpose  should be  used
8. After the maceration, as directed, the residue can be pressed out. The un-dissolved residual substance should be lightly triturated in a mortar, adding twice its bulk of finely powdered green glass, and with the remaining half of solvent, the whole thing can be subjected to percolation.

After percolation  & subsequent filtration, the clear  liquid can be added to the   previous one  and  the  completed  tincture  one and  the   completed  tincture   can be  added  to the previous  one   and   the completed tinct6ure can be kept in a well closed bottle in a dark and cool place.

9. The contraction of volume by addition of water and alcohol and the increase in volume due to liquefaction of the medicinal substance are always to be compensated for according to the formula in a standard

10. The resultant liquid obtained after decanting is filtered using filter paper and stored in a glass-stoppered bottle in a cool dark place.

MATERIALS AND METHODS

PROVING PROTOCOL
Clinical Trial Design
Homeopathic drug provings should be similar to and the European Community (EC) guidelines for clinical research. ^{(3, 9)}

Clinical Investigators
Proving Director – There should be a proving director for the Double blind study. He should determine who should be given the drug to prove and whom the placebo so as to become the control.

Proving Supervisor/ Coordinator- His role should be to meet the provers once in three days to determine the effects of proving on the subjects and give the necessary instructions for proving.

Methodology
Data Collecting – Diary/journal format (Provers Day Book Proforma)
Study Design – Single group with placebo run-in
Method of Binding – Double – Blind
Controls – Intra-individual controls, placebo run-in, placebo controls

Technique to be used: Double blind randomized control trial using crossover technique during consecutive proving of a higher potency after proving a lower potency

Medications    The medication used in this homeopathic drug proving should be prepared in a pharmacy of repute. Standard potencies like the 3X and 30 C potencies should only be taken for proving.

Subject Population
To add statistical stability to the study at least 30 subjects must be chosen to undergo the study. The proving director must divide the population into two groups : Provers and controls

PROVING TIME-LINE

Week	1	2	3	4	5	6	7	8	9	10
Initial Interview	x
Inclusion/Exclusion Criteria	x
Initial Evaluation	x
Subject Education	x
Phase I: Pre-proving observation	x	x
Phase II: Placebo run-in phase				x
Phase II: Medication/Placebo				x
Data collection in Journal	x	x	x	x	x	x	x
Phase III: Exit Interview								x
Phase III: Post-proving observation								x	x	x
Contact with Subject	x	x	x	x	x	x	x	x	x	x
Observation for adverse effects			x	x	x	x	x	x	x	x
Symptom organization/Final Report									x

SELECTION OF THE PROVERS
Apparently healthy individuals are to be taken as provers. A consent form having name, age, sex, address and an undertaking is to be used to take the consent of the provers. (A model consent form is given as Appendix). Among the provers, both males and females are to be included, to get the changes produced in the sexual sphere. Provers from different age groups are to be selected avoiding provers below 18 years and pregnant women. The male female ratio should be mentioned.

INCLUSION CRITERIA

• The volunteers should be reasonably healthy and well balanced in body, soul and spirit. They did not show any psychic or physical symptoms and did not consider themselves to be in need of medical treatment.
• The subjects are to be between 21 – 40 years of age, so that bodily degeneration that comes with age will not be a serious factor.
• The subject must be well acquainted with Homoeopathic methodology, and must have a good knowledge of the symptomatology found in Homoeopathic Materia Medica. This is necessary for the subject to fully appreciate the particular deviations that may manifest during the proving.
• The subject must be able to lead a life which is to be as normal as possible during the course of experiment. Life circumstances of the individual are to be such as to allow a definite time for sleep, for walking and for eating etc.
• The subject must be intelligent enough to properly appreciate and record the subjective symptoms as deviations from his normal condition of life. These subjective symptoms are of utmost value.
• Honesty is a pre-requisite of a good prover, for he must be very careful to record all phenomena from the very beginning of the trial.
• Laboratory tests consisting of a CBC, Hb %, ESR, serum total cholesterol, random blood sugar are to be ordered on three separate occasions as follows: before onset of receiving remedy at week two, on or shortly after the last day of ingesting verum or placebo, and after the proving journal is to be completed.
• Agreed in advance to comply with instructions for keeping a journal. The subject observed and described symptoms experienced from taking a homeopathic medication.
• Did not engage in any elective medical treatments (such as surgery or dental procedures) for the duration of the homeopathic drug proving.
• Did not undergo any major life changes (moving, getting married or divorced, etc.) and continued the usual habits and patterns of daily life.
• Is to be over the age of 18, competent, and signed the informed consent.

EXCLUSION CRITERIA

• The subject should not be hysterical or anxious person. This is necessary because such individuals display a high incidence of placebo effect.
• Those who note down a lot of emotional symptoms, too many symptoms in these realms confuse the final result.
• Those who obviously omitted to recall symptoms or who exhibited superficiality in reporting.
• Those who suffer from hypersensitivity diseases such as asthma, hay fever, allergies, food hypersensitivities etc.
• Pregnant and lactating women or women under any treatment, using contraceptive pills or intrauterine devices etc.
• Subjects excluded who are to be on ongoing medical treatment during the homeopathic drug proving
• Subjects excluded who are to be on had surgery within the past 6 weeks
• Subjects excluded who are to be on is to be on prescription medication
• Subjects excluded who had taken birth control pills in the past 6 months
• Subjects excluded who failed to complete the journal as instructed
• Subjects excluded who are to be is to be under the age of 18 or lacking complete competence

ETHICAL CONSIDERATIONS

• The subjects or provers are to be in such a mental, physical and legal state as to be able to exercise fully his or her power of choice.
• Consent is to be obtained in writing from the subject. However the responsibilities always remain with the investigator or the investigating team. It never falls on the subject even after consent has been obtained.
• Nature and purpose of drug proving is to be explained to the subject or prover.
• Provings are to be never done in toxic doses.
• For toxic symptoms the reports of accidental provings recorded in toxicological literature is to be solely relied on.
• The investigator or investigating team discontinued provings, if it is to be found that continued use of the is harmful to the subject. 

NEED FOR CONTROLS
To avoid influences and bias on the part of provers and the investigator which can significantly modify drug responses and interfere with the interpretation of therapeutic efficacy of a drug, controls are to be required. Crossover technique during consecutive proving of a higher potency after proving a lower potency

PRECAUTIONS ; Care is to be taken that nothing which may ruin the health be proposed for proving.

PRE-TRAIL MEDICAL EXAMINATION OF THE PROVER

As it is nearly impossible now almost impossible to find perfectly healthy provers, strict inclusion criteria is used to find perfectly healthy provers. This format is to be designed to minimize any pre existing pathological symptoms. Case taking of the provers is to be before the proving to ensure the safety of the volunteer, to make sure that they are healthy enough to take part in a proving and to give a baseline of the actual state of health and symptoms. This is done in a Pre-trial medical examination Proforma. The physical and clinical examination along with the constitutional, mental, emotional and physical traits are to be recorded in this form. Routine lab investigations (CBC, Hb %, ESR) along with blood sugar and serum cholesterol level are to be assessed. Lab investigation confirmed the fitness of the provers. Pre observation period of one week is to be made before intake of the remedy.

GUIDELINES TO PROVERS
All the provers are to be given the following guidelines before starting the proving.

• To lead a normal life and to stick by earlier routines during the proving experiment.
• To avoid overexertion mentally and physically.
• To avoid any medication during proving.
• To have a simple diet with minimum spices and to avoid consumption of alcohol and smoking.
• To avoid articles in diet which has established medicinal properties in the crude state.
• To report everyday to the proving master or write down all the details by themselves.
• To avoid external influences which may modify or distort the results.
• To mention any probable exciting or precipitating factors. Also note down any article knowingly or unknowingly taken by a prover that may interfere with the proving.
• To avoid the communication of symptoms obtained to other provers.
• To avoid exposure to articles which may possibly act a an antidote to the drug being proved like camphor, smoke form mosquito coils or pesticides.

SELECTION OF THE DRUG
After discussion with experts in different fields, the drug should be selected which has  proved its action in the traditional system of medicine.

The pharmacognosical identification is to be done by expert biologist if it is plant drug.

STANDARDISATION OF THE DRUG FOR MOTHER TINCTURE PREPARATION

ORGANOLEPTIC EVALUATION Shape Leaf Flower Seeds Fracture Smell Taste Touch Moisture content

STANDARDISATION OF THE MOTHER TINCTURE Colour of tincture Smell pH Specific gravity Solubility of powdered drug A.     In water B. In alcohol Precipitation test Identification A. TLC method

The moisture content is to be first found out after heating the drug in a crucible. I will give an example:

Weight of crucible = 69.5 gms

Weight of drug substance and crucible before heating. = 79.5 gms

Therefore initial weight of drug substance = 10 gms

Weight of drug substance and crucible after drying by heat = 73 gms

Therefore final weight of drug after drying = 3.5 gm

Moisture content in 10 gm of drug substance = 6.5 ml

% of moisture = 6.5  X 100 / 10 = 65 %

MOTHER TINCTURE PREPARATION (example shown – Plant Evolvulus Alsinoides)

100 ml of mother tincture is to be made using:

10 gm of dried drug whole plant

18.5 ml of distilled water (to compensate for the moisture content).

81.4 ml of alcohol.

The drug  substances are made a pulp(magma). The pulp is to be placed in a macerating jar, made of glass. 81.5 ml of  alcohol (pre –calculated) is to be added to cover the whole mass of drug substances. 18. 5 ml of distilled water is to be also added. The macerating jar is to be now carefully corked or sealed in order to prevent the evaporation of the menstrum (alcohol).The jar is to be kept in a cool dark place, free from dust, odour, heat or direct sunlight. The temperature is better within the range of 15 C – 20 C. The jar is to be kept for 2-4 weeks and is to be shaken everyday.

After this period, the clear liquid above is to be decanted off and the residue can be pressed out through a piece of linen cloth or bag, adding more of prescribed menstrum if necessary to make the required volume.

After the maceration, the residue is to be pressed out. The   un-dissolved residual substance is to be lightly triturated in a mortar, adding twice its bulk of finely powdered green glass, and with the remaining half of solvent, the whole thing is to be subjected to percolation.

After percolation  & subsequent filtration, the clear  liquid is to be added to the   previous one  and  the  completed  tincture  one and  the   completed  tincture   is to be added  to the previous  one   and   the completed tincture is to be  kept in a well closed bottle in a dark and cool place.

The resultant liquid obtained after decanting is filtered using filter paper and stored in a glass-stopper bottle in a cool dark place.

POTENCY PREPARATION
The decimal potencies are to be first prepared by taking one ml of previous potency and succussing 10 times with 9 ml of alcohol. Similarly, the centesimal potencies are to be made by taking one drop of the previous potency and succussing 10 times with 99 drops of alcohol.

THE PLACEBO RUN-IN PHASE
In this phase of study, initially every prover is given placebos for a period of one week to record the efficiency of the prover in the Panamanian proving experiment. During this phase it is seen if the prover is recording properly in his Day Book Porforma and if the patient is really trustworthy.

THE PROVING
Proving is to be done with standard preparations of the drug in its 3 X and 30 C potencies. The potencies are to be given in clean phials and medicated in number 40 globules and are to be given to the provers. Identical phials of globules moistened with dispensing alcohol are to be used as placebo for the controls.

Care is to be taken that nothing which could irreparably ruin the health of the prover is to be administered and proving is to be never done in toxic doses.

THE EXPERIMENT
The outline of the human drug proving experiment along with the available literature of the drug under consideration and the drug proving protocol is to be provided to the ethical committee. The main objective of the ethical committee is to safeguard the welfare of the provers involved in the proving experiment. The chairman, member secretary, constitutes the ethical committee members including a legal advisor. Consent for the proving experiment is to be provided by the Ethical committee.

Divide the whole population of subjects into two groups ‘provers’ and ‘control’ using randomization techniques. Consent form is to be obtained with signatures from two witnesses from every person coming under the double blind randomized control trial of drug proving.

The human drug proving of the drug is to be done in 30 persons for a period of 3 months. Controls are to be later used as provers when the second potency is to be given (Cross over Design). The provers are to be educated about the need and importance of such a proving trial and proper guidelines are to be given for the recording of the symptoms.

Four globules (of No. 40 size) are to be considered as a single dose. The globules are to be administered dry on the tongue. The prover is to be asked to note the date and time of administration of the medicine in his daybook. All the symptoms, both the objective and subjective appearing after the intake of medicine, along with the time of appearance, the location, sensation, modalities, the intensity, and the concomitants are to be noted down by the provers.

If the first dose did not produce any effect, then after lapse of considerable time subsequent doses are to be administered to create sensitiveness to the drug. If still no symptoms appeared the dosage of drug are to be repeated three tomes daily till symptoms appeared. If the prover is to be still found to be insensitive to the drug then the same dosage of 4 globules is to be administered at an interval of 2 hours till the symptoms appeared.

If the provers did not experience any symptoms after the intake of a dose of medicine he is to be made to write down ‘no symptoms appeared’ in his daybook.

Each prover is to be provided sufficient number of pre-designed Provers Day Book Proforma to record all the signs, subjective and objective symptoms that he might observe during the course of proving.

The provers are to be directed to report to the proving investigator / master prover every day and hand over the recorded symptomatic data.

The proving investigator elaborated each symptom by writing down the location, sensation, modalities, concomitants and extensions. A detailed record of the order of the appearance of symptoms is to be recorded. Recording in the day book is to be made without biased ideas about the outcome of the provings. (Symptom Elaboration Proforma Appendix V)

In the event of any provers developing any signs / symptoms, administration of the drug is to be stopped immediately and the drug is to be not administered as long as those signs / symptoms persisted.

The trials are to be started by using 3 X and controls and later using the cross over single blind randomised technique, 30 C and controls are to be proved. In the case of those provers proving both 3 X and 30 C potencies, a wash out period of 2 weeks is to be given to neutralize the effect of the previous potency (3 X) and then the 30 C is to be administered. This wash-out period constitute the period under which the action of the proving potency slowly diminishes and is completely removed. The dosage, the mode of administration and the repetition of the 30 C or its control is to be similar to the 3 X potency. During the course of the proving, the proving investigator took care to ascertain and record atmospheric changes and alterations in the sleep, dreams and eating habits of the provers to ensure evolution of the true drug pathogenesis.

SYMPTOM COLLECTION AND EVALUATION
Subjects noted symptoms in their journals for five weeks and are to be in daily contact with the proving supervisor. The symptoms experienced after the administration of the medication are to be compared with baseline pre-proving observations and evaluated according to the criteria. All symptoms from the placebo run-in period are to be eliminated for all subjects. Symptoms experienced during the randomization phase are to be excluded for a subject if they are to be the identical to symptoms experienced during the placebo run-in phase. Symptoms from those subjects receiving placebo after the placebo are to be also excluded in the final evaluation. All subjects are needed to complete an exit interview where each symptom experienced is to be reviewed again for additional clarification. All symptoms are to be reviewed by the proving supervisor. It is to be specially assessed, if the there are to be any adverse effects noted at the time of the exit interview or during the post-proving observation period.

GUIDELINES THAT ARE TO BE GIVEN TO THE PROVER AND THE INVESTIGATOR FOR THE RECORDING OF SYMPTOMS

• Adherence to the protocol, honesty and sincerity are to be pre requisites both on the part of the investigator, master prover and the provers.
• The provers must make daybook entries at least 3 times in a day, to prevent even minor memory lapses.
• Each entry should record event the slightest deviation from the subjects’ normal state.
• Intensity and duration of the symptoms should be carefully recorded. Possible exciting cases should be recorded meticulously.
• A detailed record of the order of appearance of all the symptoms should be made.
• Analysis of the symptoms such as location, sensation, duration and the modifying characters of the symptoms, together with concomitants should be properly recorded.
• Recording should be done without biased ideas about the outcome of the provings.

WAYS OF MINIMISING ERRORS

• There are to be frequent meetings between investigators and subjects to record the elaboration and classification of each symptom. The subject is to be ensured that the information would be treated as confidential.

POST-TRAIL EXAMINATION OF THE PROVERS
After completion of the experiment, all the provers are to be again subjected to an examination. This is the Exit Interview of the provers and controls.  All the physical and mental symptoms are to be recorded. Similar lab investigations are to be again carried out as is to be done in the pre-trial medical examination. This is given as the Post-Trial Medical Examination Proforma.

DATA COMPILATION, INTERPRETATION AND FORMATION OF MATERIA MEDICA OF EVOLVULUS ALSINOIDES
Every day the records in the daybook of the provers are to be assessed and evaluated, all the symptoms which represent deviations from the normal health are to be listed. A comparison of the daybook entries is to be made to the pre-trial and post-trail medical examination reports. The symptoms generated by controls (those on placebo) are to be deleted from the records. All the remaining symptoms are to be collected and a Materia Medica is to be formed.

During the compilation of the data, care is to be taken to record it in the words of the provers.

Those signs and symptoms, which are to be distinctly experienced by the prover(s) and whose truth is confirmed are arranged in a schematic manner (according to Boericke’s Materia Medica).

INCLUSION OF THE SYMPTOMS IN THE RUBRICS OF THE SYNTHESIS REPERTORY
Repertories have helped conscientious homoeopaths in their struggle for the right remedy as long as homoeopathy has existed. Hahnemann himself made some first steps in steps in structuring his information into some kind of repertory. However, it is to be his immediate discipline and collaborator Clemens Von Boeninghausan who can be credited with creating the first usable repertory in 1832.

Different authors expanded on previous versions of this repertory like Allen, Jahr, and Von Lippe. Some created completely new structures, as did Gentry and Knerr. It is to be Dr. Kent, who published a repertory from 1897-1899, with a structure and a hierarchical logic that would stand the test of time.

The Synthesis repertory is a byproduct of the Radar-project. It is based on the Sixth American Edition of the Kent’s Repertory, and contains all its rubrics and remedies. The Synthesis Repertory remains one of the most widely used repertories by the Homoeopaths in the recent times. Thus, after the recording of the symptoms obtained during the Hahnemannian drug proving and the creation of the Materia Medica for the drug, the name of the drug is now included under the rubrics in the Synthesis Repertory using abbreviations for representing the drug.

BIBLIOGRAPHY

1. BOERICKE WILLIAM – “Organon of Medicine” – translation, 6^th edition, 1989, pages 27, 187-212
2. DUDGEON R.E, “Organon Of Medicine” – translation. Pages – 80 – 92, and 203.
3. EDZART ERNST and ECKHART. G. HAN 1995, “Homoeopathy Appraisal”, Pages – 3, 28, 29, 63 – 71 and 95.
4. HAHNEMANN. SAMUEL, “Materia Medica Pura” – Volume I , reprint edition 1999, B. Jain Publishers, New Delhi, Page 1-5.
5. HAHNEMANN. SAMUEL, “Organon of Medicine” M. Batacharcya and co. P. Ltd, Culcutta, 1987, Pages 123, 179 -196.
6. NAGAPAUL V. N 1987, “Drug Proving and Centre for Research in Homoeopathy” CCRH, New Delhi.
7. SUBRATA KUMAR BANERJEA, Practical Tips with Clinical Comparisons, B. Jain Publishers (P) Ltd, New Delhi.
8. SUMIT GOEL, Homoeopathic Pharmacy, Chapters 36 and 37.
9. www. homoeopathy – eech. Org / provings. html
10. www.homeoint.org/cazalet/lippe/drugproving.htm
11. www.wholehealthnow.com/books/pharmacy.html

(Article published in Homeopathic Heritage – Aug 2008. No part of this article may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or by any information storage and retrieval system, without permission in writing from the author.)

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