An open-label, exploratory documentation of proving-symptoms of CVN01 (Coronavirus nosode from the clinical sample) in healthy volunteers
Gitanjali Talele1, Rajesh Shah *2
1 – Research Associate, Life Force Foundation Trust, Chembur, Mumbai 400089 India
2 – Research Head, Life Force Foundation Trust, Chembur, Mumbai 400089 India
* firstname.lastname@example.org – https://orcid.org/0000-0001-6267-2839
Homeopathic Pathogenetic Trials (Proving) are human studies to examine the pathogenetic effects of investigational drugs in high dilution on healthy volunteers. As a part of the new coronavirus nosode development process for prophylactic use, the phase 1 study was conducted. The documentation of proving symptoms for a fast-track nosode development for a pandemic condition was the objective of this study.
Materials and methods: An open-label trial to evaluate the safety and proving symptoms of Coronavirus nosode given orally to 10 volunteers (18- 65 years age and of both genders). Volunteers were administered 6 doses of nosode as 6 pills twice daily in 30c dilution (size 30 globules) for 3 consecutive days. Pre and post-examination (physical), vital signs, and laboratory investigations were done on days 0, 17, 34. Symptoms experienced by the volunteers were recorded.
Results: Symptoms reported by volunteers were analyzed. The symptoms reported were mild to severe but reversible and matching with the symptoms produced by the viral infection. There were no serious/fatal adverse events during the study. The basic biochemistry and Liver Function tests were not affected by the Nosode.
Conclusion: New nosode developed during a pandemic condition produced specific symptoms in the homeopathic pathogenetic trial as a part of the Phase 1 study.
Keywords: SARS-CoV-2, COVID-19, nosode, homeopathic pathogenetic trial, drug proving