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CONFERENCE REPORT
Year : 2014  |  Volume : 8  |  Issue : 1  |  Page : 46-66

Proceedings of interactive meet on harmonisation of drug proving programme


1 Director General, Central Council for Research in Homoeopathy, New Delhi, India
2 Assistant Director (H), Central Council for Research in Homoeopathy, New Delhi, India
3 Research Officer (H), Central Council for Research in Homoeopathy, New Delhi, India

Date of Web Publication29-Mar-2014

Correspondence Address:
Raj K. Manchanda
Director General, Central Council for Research in Homoeopathy, New Delhi
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0974-7168.129680

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  Abstract 

An interactive meet for harmonisation of drug proving programme of the CCRH was held on 17 September 2013 with an objective to exchange information on standards and methods of proving in the USA, Europe and India and promote international collaboration and harmonisation of drug proving protocol. The Council is in the process of revising its drug proving protocol based on the deliberations of the meet.

Keywords: Drug proving, Homoeopathic pathogenetic trial, Homoeopathy, Protocol, Harmonisation, Drug pathogenesis


How to cite this article:
Manchanda RK, Khurana A, Taneja D. Proceedings of interactive meet on harmonisation of drug proving programme. Indian J Res Homoeopathy 2014;8:46-66

How to cite this URL:
Manchanda RK, Khurana A, Taneja D. Proceedings of interactive meet on harmonisation of drug proving programme. Indian J Res Homoeopathy [serial online] 2014 [cited 2019 Jul 22];8:46-66. Available from: http://www.ijrh.org/text.asp?2014/8/1/46/129680


  Background Top


Drug proving is one of the principle activities of homoeopathic research. It was started in 1963 under the Homoeopathic Research Committee constituted by Government of India. The work was subsequently carried forward by the Central Council for Research in Homoeopathy (CCRH). Kali muriaticum[1] was first drug that was re-proved, there after Abroma augusta folia and Cassia sophera were proved considering their wide use by Indian homoeopaths. [2],[3] The focus of the CCRH's drug proving programme is on proving of fragmentarily proved and indigenous drugs. Till now, the CCRH has proved more than 100 drugs. The data has been published in CCRH quarterly bulletins and Indian Journal of Research in Homoeopathy (IJRH), [4] monographs and Councils publications. [5],[6],[7],[8],[9],[10] A research protocol was developed in 1987, [11] which was modified in 2007 and was further modified in 2010. Primarily the provings were conducted using double-blind placebo-controlled design. The initial proving were conducted even using mother tinctures and lower triturations but later on only potencies (6-200) are being used.

Drug proving protocols have been a subject of intense debate internationally, the protocols/guidelines have been developed by Liga Medicorum Homoeopathica Internationalis (LMHI), [12] European Committee for Homeopathy (ECH) [13] and Homeopathic Pharmacopoeia Convention of the United States (HPCUS). [14]

Over the years, a need was felt to bring in harmonisation in these proving guidelines, which will be of mutual benefit for the organizations to be in consonance with each other and develop a set of globally acceptable guidelines. This step plays a vital role in regulatory requirements in the countries with regard to new drug discovery in homeopathy. The subsequent drug monographs developed will assure methodological quality and would be more acceptable to the international community. Dr. Robert van Haselen, Editor in chief, Journal of Complementary Therapies in Medicine and member of the Proving and Clinical Evidence Working group of the HPCUS and the Research Working Group of the (ECH) was invited to the Council. An interactive workshop on the harmonisation of drug proving programme of the Council was held on 17 th September 2013 at New Delhi. The objective was to exchange information on standards and methods of proving in the USA, Europe and India and promote international collaboration and harmonisation of drug proving protocol. Attended by over 80 participants, the event brought together scientists, administrators and academicians associated with drug proving programmes in the country.


  Proceedings Top


The interactive meet was inaugurated by Shri Nilanjan Sanyal, IAS, Secretary, Department of AYUSH, Ministry of Health and Family Welfare, Govt. of India. He stated that harmonisation of global standards is the need of the hour and Council should undertake internationally acceptable researches. The participants of the workshop included Dr. V.K. Gupta, Chairman, Special Committee on Clinical Research, Dr. Niranjan Mohanty, Chairman, Special Committee of Drug Proving, Dr. Raj K. Manchanda, Director General, CCRH, Dr. Anil Khurana, Assistant Director, CCRH, nine scientists engaged in drug proving program, 16 proving associates (faculty from colleges conducting drug proving in collaboration with Council) and 24 other scientists and research administrators of the Council.

Dr. Haselen made a presentation on drug proving in the USA and Europe: Current status, Proving guidelines and methodology. He compared the proving guidelines of the LMHI (version 2, April 2013), ECH (Version 1.1, June 2011) and HPCUS (Version 2, April 2013). Presentation about the development of drug proving programme of CCRH was made, also highlighting the main aspects of the proving protocol. It was compared with the chart of Dr. Haselen and discussion took place on every point.

Major Discussion Points

During proving, symptoms appear in both the control and verum group. As per certain recommendations, those symptoms be also included in the monograph, indicating them as placebo symptoms. [6] It was much debated upon, if the placebo symptom reporting will have any utility to the profession. In CCRH, the symptoms found to be common in all respects in both verum and control are recorded but are not reported in the drug pathogenesis. It was decided to retain the process.

The profile of provers developing symptoms on drug or placebo needed to be understood, so that a general constitution of the drug could also be derived. Since provings are conducted in different geographical terrains and different climates, the drug proving symptoms can be completed in relation to causative factors and environmental changes.

Drug Proving symptoms can be graded as per their value, that is symptoms appearing in more number of provers, peculiar, rare and uncommon symptoms, symptoms reappearing from prior proving, symptoms persisting for long duration.

The safety profiling of the drugs must be conducted prior to undertaking proving. The drug proving protocols need to detail the mechanisms of identification and reporting of adverse events and adverse drug reactions.

It was suggested that proving should be made a part of homoeopathic graduation and post-graduation curriculum for meticulous involvement of students.

Outcome

The comparative statement of the guidelines of the LMHI, ECH and HPCUS as provided by Dr. Haselen was elaborated to incorporate the protocol of the Council. The outcomes of the discussion have been summarised in the last column of the comparative table (Appendix)[Additional file 1] . The Council is in the process of revising its drug proving protocol incorporating these outcomes.

 
  References Top

1.1. Central Council for Research in Homoeopathy. Kali Muriaticum. New Delhi: CCRH; 1986.  Back to cited text no. 1
    
2.2. Central Council for Research in Homoeopathy. A proving of Abroma augusta folia. New Delhi: CCRH; 1986.  Back to cited text no. 2
    
3.3. Central Council for Research in Homoeopathy. A proving of Cassia sophera (incorporating clinically verified symptoms). New Delhi: CCRH; 1987.  Back to cited text no. 3
    
4.4. CCRH. Archives of Indian Journal of Research in Homoeopathy. http://ccrhindia.org/old_ijrh.asp [accessed on 2014 Feb 26].  Back to cited text no. 4
    
5.5. CCRH. Homoeopathic Drug proving. New Delhi: CCRH; 2005.  Back to cited text no. 5
    
6.6. CCRH. Homoeopathic Drug Provings. Vol. 2. New Delhi: CCRH; 2007.  Back to cited text no. 6
    
7.7. CCRH. New Drugs Proved by CCRH. New Delhi: CCRH; 2008.  Back to cited text no. 7
    
8.8. CCRH. Homoeopathic Drug Provings. Vol. 3. New Delhi: CCRH; 2009.  Back to cited text no. 8
    
9.9. CCRH. Homoeopathic Drug Provings. Vol. 4. New Delhi: CCRH; 2011.  Back to cited text no. 9
    
10.10. CCRH. Homoeopathic Drug Provings. Vol. 5. New Delhi: CCRH; 2014.  Back to cited text no. 10
    
11.11. Nagpaul VM. Provings-planning and protocol. Br Homoeopathy J 1987;76:76-80.  Back to cited text no. 11
    
12.12. Ross A., Wassenhoven MV. Second Edition of LMHI Guidelines for a Homeopathic Drug Proving (HDP). Available from: http://liga.iwmh.net/index.php?menuid=95andreporeid=310 [Last accessed on 2014 Feb 26].  Back to cited text no. 12
    
13.13. European Committee of Homeopathy. ECH Homeopathic Drug Provings Guidelines Version 1.1 Available from: http://www.homeopathyeurope.org/publications/guidelines/homeopathic-provings/ECH_Proving_Guidelines_v1.pdf [Last accessed on 2014 Feb 26].  Back to cited text no. 13
    
14.Homeopathic Pharmacopoeia of the United States. HPCUS Proving guidelines. Available from: http://www.hpus.com/Draft-HPCUS-Proving-Guidelines.pdf [Last accessed on 2014 Feb 26].  Back to cited text no. 14
    




 

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