An open-label, exploratory documentation of proving-symptoms of CVN01 (Coronavirus nosode from the clinical sample) in healthy volunteers

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 objectives of this study. 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 the genders). Volunteers were administered 6 doses of nosode as 6 pills twice daily for 3 consecutive days. Pre and post examinations (physical), vital signs, and laboratory investigations, were done at day 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. New nosode developed during a pandemic condition produced certain symptoms in the homeopathic pathogenetic trial as a part of the Phase 1 study.

Hepatitis C Nosode: The preparation and homeopathic pathogenetic trial.

BACKGROUND: A double blind, randomized placebo controlled homeopathic pathogenetic trial (proving) of Hepatitis C (Hep C) nosode was conducted with the aim to introduce the new nosode in homeopathic pharmacopeia. METHOD: Documentation included approval by Ethics Committee, Informed Consent Form, Laboratory investigations, safety and ethical measures. The volunteers were trained to write data in prescribed diaries and data were analyzed. A fifteen-step method was used in the preparation of Hep C nosode (genotype I and III), allowing future preparation of an identical nosode. 22 volunteers were entered, 15 received Hep C nosode in 30c potency, 7 received placebo, once a week for four weeks. RESULTS: The Hep C nosode was associated with qualitatively and quantitatively distinct symptoms, which can be applied in clinical practice. A significantly higher incidence of pathogenetic effect of homeopathic medicine compared to placebo was observed. Safety was documented. The nosode produced symptoms comparable with Hep C disease. CONCLUSION: An improved method of nosode preparation was used. A double blind, randomized placebo controlled pathogenetic trial of the Hep C nosode generated guiding symptoms, which may facilitate its prescription in practice. The nosode should be further explored for the treatment of immunologically mediated diseases, infections including Hep C, fibrotic pathology and chronic inflammatory disorders.