Quantitative and Qualitative Pathogenetic Indices for Review of Data Derived from Homeopathic Pathogenetic Trials

Shah, Rajesh

doi:10.1055/s-0038-1668536

Cited by 3 publications

(2 citation statements)

References 6 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…3. The Qualitative Pathogenetic Index [12] a = (b/c)/d While undertaking the projects on drug proving, the investigator qualified every symptom by its intensity, as explained above. This allowed the qualification of individual symptoms.…”

Section: Indices Calculationmentioning

confidence: 99%

Randomized, Placebo-controlled Homeopathic Drug-proving of SARS CoV-2 nosode (BiosimCovex) in healthy volunteers

Shah,

Talele

2024

Int J High Dilution Res

View full text Add to dashboard Cite

Introduction The Homeopathic Pathogenetic Trial (HPT, Drug-proving) is a systematic examination and recording of the symptoms experienced by healthy volunteers after an administration of an investigational medicinal substance. Randomized, placebo-controlled HPT was conducted using BiosimCovex (SARS CoV-2 nosode) in healthy volunteers. Materials and methods BiosimCovex 30c was given orally in a randomized, placebo-controlled trial to examine the safety and pathogenetic effects of 30 volunteers (18- 65 years of age and both genders). Volunteers were administered a dose of 6 pills of the nosode once a day for two weeks followed by 30 days observation period. Pre and post-examination (physical), vital signs, and laboratory investigations were done with a run-in period of 7 days. Symptoms experienced by the volunteers were recorded and analyzed, and Qualitative and Quantitative indices per volunteer were reported. Trial registered at http://ctri.nic.in (CTRI/2022/06/043392). Results BiosimCovex nosode exhibited quantitatively distinct symptoms, which can be applied in clinical practice. The number of symptoms reported in the verum arm was 73 (placebo 11). The incidence of the Pathogenetic effect per volunteer in the verum group was 8.1 vs that of the placebo 5.5. The Qualitative Pathogenetic Index was 0.295 in the verum group as compared to the placebo 0.193. The symptoms observed matched with the symptoms produced in an open-label Phase 1 study conducted during the COVID-19 pandemic and also with that of the viral infection. There were no serious/fatal adverse events during the study. Safe use was documented. Conclusion BiosimCovex nosode developed during a pandemic condition produced specific symptoms in the homeopathic pathogenetic trial which could be used in clinical practice.

show abstract

Section: Indices Calculationmentioning

confidence: 99%

Randomized, Placebo-controlled Homeopathic Drug-proving of SARS CoV-2 nosode (BiosimCovex) in healthy volunteers

Shah,

Talele

2024

Int J High Dilution Res

View full text Add to dashboard Cite

show abstract

“…This tool helps researchers to compare the symptoms of the post-intervention phase of a trial subject with the pre-intervention phase (baseline symptoms). Second, the two methods of Shah 6 , termed the qualitative pathogenetic index and the quantitative pathogenetic index, estimate each trial subject's intensity and the number of symptoms. The above three tools focus on the attributes of the symptoms presented by the intervention group but they fail to analyze the symptoms of the placebo group as a comparator.…”

Section: Introductionmentioning

confidence: 99%

An Attempt to Estimate the Noises in Homeopathic Pathogenetic Trials by Employing the Jaccard Similarity Index and Noise Index

Poruthukaren

2021

Homeopathy

View full text Add to dashboard Cite

Background The critical task of researchers conducting double-blinded, randomized, placebo-controlled homeopathic pathogenetic trials is to segregate the signals from the noises. The noises are signs and symptoms due to factors other than the trial drug; signals are signs and symptoms due to the trial drug. Unfortunately, the existing tools (criteria for a causal association of symptoms only with the tested medicine, qualitative pathogenetic index, quantitative pathogenetic index, pathogenic index) have limitations in analyzing the symptoms of the placebo group as a comparator, resulting in inadequate segregation of the noises. Hence, the Jaccard similarity index and the Noise index are proposed for analyzing the symptoms of the placebo group as a comparator. Methods The Jaccard similarity index is the ratio of the number of common elements among the placebo and intervention groups to the aggregated number of elements in these groups. The Noise index is the ratio of common elements among the placebo and intervention group to the total elements of the intervention group. Homeopathic pathogenetic trials of Plumbum metallicum, Piper methysticum and Hepatitis C nosode were selected for experimenting with the computation of the Jaccard similarity index and the Noise index. Results Jaccard similarity index calculations show that 8% of Plumbum metallicum's elements, 10.7% of Piper methysticum's elements, and 19.3% of Hepatitis C nosode's elements were similar to the placebo group when elements of both the groups (intervention and placebo) were aggregated. Noise index calculations show that 10.7% of Plumbum metallicum's elements, 13.9% of Piper methysticum's elements and 25.7% of Hepatitis C nosode's elements were similar to those of the placebo group. Conclusion The Jaccard similarity index and the Noise index might be considered an additional approach for analyzing the symptoms of the placebo group as a comparator, resulting in better noise segregation in homeopathic pathogenetic trials.

show abstract

Proposed Standards and Regulatory Mechanisms for New Homeopathic Drug Development

Talele

Shah

2021

Homœopathic Links

Self Cite

View full text Add to dashboard Cite

Introduction Researchers working with new insights and new targets in new drug discovery in the homeopathy space observe that the path of drug-development and market authorisation has been less travelled and the pathway is not yet well-mapped. The need of the time is to define clear guidelines and regulatory mechanisms to facilitate the process of new drug discovery. Overview The article is about the proposed methods for identifying the new homeopathic substances for therapeutic use. An overview of the current regulations for drug development in India is discussed in this article. Method of new drug development in homeopathy, standards and regulatory mechanism for approval of new drugs are proposed with few illustrations and references. An introductory plan, based on the perspective and experience of researcher, practitioner, academician and inventor for drug discovery is proposed. Discussion An urgent need for setting up the guidelines for new drug discovery has been identified and a basic proposition is made for the same, suggesting practical, pragmatic and achievable measures, and independent regulatory body to encourage drug development and research.

show abstract

Quantitative and Qualitative Pathogenetic Indices for Review of Data Derived from Homeopathic Pathogenetic Trials

Cited by 3 publications

References 6 publications

Randomized, Placebo-controlled Homeopathic Drug-proving of SARS CoV-2 nosode (BiosimCovex) in healthy volunteers

Randomized, Placebo-controlled Homeopathic Drug-proving of SARS CoV-2 nosode (BiosimCovex) in healthy volunteers

An Attempt to Estimate the Noises in Homeopathic Pathogenetic Trials by Employing the Jaccard Similarity Index and Noise Index

Proposed Standards and Regulatory Mechanisms for New Homeopathic Drug Development

Contact Info

Product

Resources

About