PROTOCOL HOMOEOPATHIC PATHOGENETIC TRIAL (DRUG PROVING)
 
1. Personnel:
(At CCRH/Headquarters)
  Chief Coordinator : Director General, Central Council for Research In Homoeopathy, New Delhi
  Co-Chief Coordinator : Deputy Director (H), Central Council for ResearchIn Homoeopathy, New Delhi
  Coordinator : Assistant Director (H), Central Council for Research In Homoeopathy, New Delhi
(At Institute/ Unit level)
  Programme Officer : Incharge of the Institute/Unit
  Co-Chief Coordinator : Assistant Director (H)/ Research Officer (H) conducting theDrug Proving Programme at Institute/Unit.
(At Institute/ Unit of CCRH, functioning in Homoeopathic Medical College premises)
  Drug Proving Committee*:
 
               A Drug Proving Committee to be constituted by the Principal of Homoeopathic Medical College and duly approved by the Director General, Central Council for Research in Homoeopathy, New Delhi, will supervise the Drug Proving Programme. This Committee shall consist of the following members:
 
  Chairman : Principal of the Homoeopathic Medical College.
  Programme Officer : Incharge of Institute/Unit of the Council shall be the convener.
  Members :
i,   �Proving Master" who looking after the specific Drug Proving Programme at the Institute/Unit.
     
ii-iv,   All Heads of the Departments of Organon, Materia Medica & Repertory of the respective Homoeopathic Medical College.
     
v,   Convener may invite one teacher from the college or one specialist or one Officer of the Institute/Unit as Special Invitee in consultation with the Chairman.
     
vi,   �Proving Associate" (One teacher from the Homoeopathic college) He / She will be closely associated with the Proving Master in day-to-day activities of the Drug Proving Programme.
 
Functions of the Drug Proving Committee
 
  1.   The committee will meet fortnightly during Drug proving to: -
     
i,   scrutinize the data recorded by the Provers, Proving Master/Proving Associate.
ii,   scrutinize the records of Pre-trial Medical Examinations (PME) carried out in the beginning of trial, Terminal Medical Examinations (TME) carried out at the conclusion of the trial and any other additional investigations or examinations carried out during the period of the trial.
iii,   finalize/approve the proving data in respect of each coded drug.
  2.   The Proving Master  will submit all relevant records to the Drug Proving Committee.
  3.   Incharge of the Institute/Unit will forward the Proving data, approved by the committee, to the Co-Chief Coordinator, the incharge of the Drug Proving Programme in the CCRH headquarters, New Delhi.
      * If any member of the Committee retires or transferred or ceases to hold the post, he/she will be replaced by the successor with intimation to the Director General, CCRH
 
3. INTRODUCTION
  3.1- Background
       Prior to Hahnemann, the systematic and extensive human experimentation of Drug had not been so meticulously done. In the history, about 2000 BC, there is the mention of Shen Nung, Emperor of China who tested herbs upon himself for eliciting therapeutical efficacy. Later, in the sixteenth century, Paracelsus, the veritable Luther of Medicine preferred medicines that he had tried on himself and the Zurich doctor, Conrad Gessner actually experimented drugs, usually derived from plants, on himself. Albrecht von Haller recommended this procedure but mostly for his work in physiology. Another person of note was the Viennese Anton Stoerck who tried the drugs first on animals, and then on him. It is surmised by some that Hahnemann, as a former Vienna student, may have got the idea from him. Hahnemann was the first person to provide a precise scientific basis for these desperate investigations, and bring them into a comprehensive therapeutic context. In his study of Cinchona Bark, which he carried out on himself in 1790 he observed that this drug produced the typical symptoms of Malaria. His experiments on Cinchona Bark led him to his formulate Law of Similars, and also marked the beginning of the systematic performance of homoeopathic drug provings.
       �Drug Proving is a method, unique to Homoeopathy where the pathogenesis of a drug is evolved through its trials on apparently Healthy Human Volunteers (Provers). Hahnemann, also well known as the Father of Experimental Pharmacology  for developing a totally new principle for ascertaining the curative power of medicinal substances, tested 99 drugs in all, on himself, his family and his colleagues, in order to discover beyond doubt, the peculiar effects of drugs on human's health. In this context he stressed the need of proving drugs on healthy persons, which is the best way to obtain an unadulterated picture of the drug. In his �Organon of Medicine (?105 -145), Hahnemann gave detailed instructions regarding the method of homoeopathic drug proving in healthy subjects.
       Keeping in view the importance of �Drug Proving" for the growth of Homoeopathy, the Council has undertaken the drug-proving programme on priority.
 
  3.2- Rationale
  The selection of Similimum is based on matching the symptom totality of the patient and drug and a correct symptom-totality of a drug can be obtained only by eliciting the effect of the drug on healthy human beings in various potencies. Therefore, Homoeopathic Pathogenetic Trial (Drug Proving) of a drug is essential to get this information.
 
  3.3- Usefulness
  Drug Proving is the building block of Homoeopathic Materia Medica. Primary action of a drug substance should be known before it can be taken as a �Homoeopathic Drug". A well-proved drug will help in the construction of an authentic Homoeopathic Materia Medica, which, in turn, will facilitate the selection of a Similimum, and in the annihilation of the disease.
 
  3.4- Objective
  To find out the pathogenetic effects of a drug on healthy human beings.
 
  3.5- Hypothesis
  The latent healing power of a drug is unfolded by the method of �Potentisation i.e. successive dilution followed by agitation and this is exhibited in the form of various signs and symptoms produced by the drug when it is given to healthy human beings.
 
  3.6- Study design
  3.6.1- The Central Council for Research in Homoeopathy is conducting systematic procedure of testing drugs on healthy human beings through Interventional, double blinded, randomized, placebo controlled, parallel study.
       
  3.6.2- Locations of the study
 
  1. Central Research Institute (H)   NOIDA (Uttar Pradesh)
  2. Central Research Institute,   Kottayam, (Kerala)
  3.  Regional Research Institute (H)   Gudivada (Andhra Pradesh)
  4.  Homoeopathic Drug Research Institute (H)   Lucknow (Uttar Pradesh)
  5.  Drug Proving Research Unit (H)   Kolkata (West Bengal),
  6. Regional Research Institute (H), Ext. Unit of Puri    Bhubaneswar (Orissa)
 
  3.7- Approach
  To prove or disprove the hypothesis as stated above.
 
  3.8- Duration of study
  Drug Proving is a continuous process and a complete proving trial of any drug takes time. A drug is believed proved well when any further trial of the drug on healthy persons does not give any additional or new symptom; therefore, no fixed duration of study can be prescribed. However, one Institute/Unit will be assigned three drugs to be proved in a year. One proving programme will consist of 3 quotas of the drug. Drug Proving will be on multi-centric basis. This will include selection of provers, Pre-trial medical examination (PME), completion of all quota(s) and post trial medical examination (TME). The same drug will be proved in different centers under the same protocol before releasing the data for professional use. Hence one drug may take 6 months to 1 year to be completed in all respects. This duration may however be extended in case the trial is not completed in the scheduled time at any Institute/Unit.
4 STUDY DESIGN IN DETAIL
[Archived image unavailable]
 
  4.1- Selection of provers
  Applications (Form A) from 15-20 volunteers (out of which 6 including 3 males and 3 females should be from non- homoeopathic background) for each drug proving programme will be invited from apparently healthy, males & females above the age of 18 years through notices on notice boards of the Institutes/Units/College. The Incharge of the Institute/Unit, Proving Master/Proving Associate, teachers may motivate the students/staff of the Homoeopathic Medical College to participate in the Proving Programme.
 
  4.2-Inclusion criteria
 
  • Age: Above 18 years of age.
  • Sex: Both male and female volunteers.
  • Health status: Experts acceptance for certifying that participant is healthy.
  • Participant must be two months clear of any homoeopathic remedy with no significant change in last 3 weeks.
  • Intelligent enough to record carefully the facts, subjective and objective symptoms generated by the drug during proving.
 
  4.3-Exclusion criteria
 
  • Volunteers suffering from any acute or chronic disease.
  • Volunteers under any kind of medical treatment.
  • Hysterical or anxious persons (such individuals display a high incidence of �Placebo effects).
  • Persons having history of allergies, food hypersensitivity etc.
  • Women during pregnancy, puerperium and while breast-feeding.
  • Persons with colour blindness.
  • Persons having addictions- brandy, wine, alcohol, narcotics, tobacco
  • Persons who has undergone surgery in last two months.
  • Hysterical, prone to hypersensitivity reactions (Like asthma, allergies), Anxiety prone, emotionally disturbed, colour-blind, suffering from any chronic disease, pregnant, puerperal, lactating females.
  • Previous homoeopathic treatment in last two months
  • Participation in another clinical or proving trial during the last 6 months
 
  4.4- Written Informed Consent
  A �Written Informed Consent (Form B) must be obtained from each selected volunteers before starting the drug proving. All volunteers will be informed about the objectives, benefits of the trial through Provers Information Sheet (Form C). Proving will be conducted in potencies only, which ensures non-toxic state of the trial drug and thereby considered safe for the provers.
  All the volunteers will undergo:

i) General Examination (Form D, Part-I), to be done by the Proving Master/Proving Associate,

ii) Pre-trial Medical Examinations (Form D, Part-II), to be done by the Honorary Consultants,

iii) Pathological report (Form D, Part-III) to be prepared by a pathologist.

 
  4.5- Photograph
  Each selected prover will have to provide his/her two photographs, to Proving Master in full pose, facing camera for record.
Note- Complete PMEs (Form D, Part I, II, III) of volunteers declared fit by the Honorary Consultants for Drug Proving will be sent to Co-Chief Coordinator (Drug Proving) at CCRH/Hqrs., New Delhi alongwith copy of application & Written Informed Consent for allotting code numbers and supply of drug quota to start Drug proving programme.)
 
5- DRUG TRIAL
  After the final approval of the Chief Coordinator, Director General, CCRH/Hqs., New Delhi, the provers will be awarded code numbers and the coded drug of different quotas will be supplied by CCRH/Hqrs., New Delhi in separate phials bearing code number pertaining to respective provers. The drug will be taken as per instructions (Methodology) given below.
6. Methodology for Drug Proving
 
Study Design
 
 
  • Design recommended
    1. Study Type: Interventional Study Design: Allocation Randomized
    2. Control: Placebo Control
    3. Intervention Model: Parallel  Assignment
    4. Masking: Double Blind
 
 
  • Source and Nature of testing substance
    1. One source can be Pharmacopeias where the details are explained
    2. For new substances:
      1. Medicinal plant grown in the research garden and standardized subsequently, as per requirement of pharmacopeia
      2. Complete identification of the substance- Plant, animal, mineral, etc.
      3. Part to be taken up and its justification
    3. Justification of the new substance being proved including the background literature, pharmacological, toxicological literature available about the substance
    4. Medicine should be procured from a pharmacy having GMP certification
Pre-trial Medical Examination (PME): It is conducted to confirm health status of the volunteers. The volunteers declared healthy, are enrolled as �Provers" in the study.
 
Coding
                Each prover is allotted a code number which bears drug code, proving center code and his/her serial number. The same code number is also labeled on the glass phials of the drug to be proved (Verum or placebo, as the case may be) by him/her. The coding of the drug/placebo is done at the CCRH headquarters.
 
 
  • Potencies to be proved
 
POTENCIES
PROPOSED		 6C, 30C, 200C
LM (for pilot proving)
Order In ascending order
Placebo/td> Placebo consists of pure sucrose globules that are not potentiated but impregnated with dispensing alcohol. The administration scheme is identical in the placebo control group to that of the intervention group
 
 
Dose
                The study consists of different quotas (as per different potencies). Each quota of the drug is given in 12 doses. Each dose consists of 4 pills (Size 20) to be taken dry on tongue. The provers are asked to take 4 doses in a day (4 hourly) for 3 days of a particular quota of the coded drug.
                Duration of each quota may vary in accordance with development of symptoms while the prover is taking regular doses as mentioned above.
 
Process of Proving
 
 
  • Dietary guidelines for Provers- Prover to follow the normal daily routine and dietary habits. Prover should avoid as far as possible all potential antidoting factors such as tea, coffee, recreational drugs, camphor, eucalyptus, menthol, mint and any substance they are sensitive to during proving.
  • Before commencing the study, all the volunteers are screened as per the Protocol. Each prover notes down daily, the details of his/her feelings/changes in mind and body, after taking the drug, in the �Prover� Day Book Proforma.
 
  A. If no sign(s)/symptoms(s) appear:
 
  Prover may not develop any sign/symptom till the completion of 12 doses; even if no sign&/symptom is observed, the prover notes down as �No Symptom with date and time of intake of the respective dose of the drug.
 
  B. If sign(s)/symptoms(s) appear:
 
  The prover is asked to stop taking the drug as soon as he/she feels any change or any sign(s) &/or symptoms(s) develop during the trial. The prover notes down the sequence of the appearance of new sign(s) &/or symptoms(s), their progress and the number of doses after which each sign &/or symptom appears with date, time of onset and duration for which it persists. The intake of drug remains suspended till the sign(s) &/or symptoms(s) totally disappear.
 
            Each prover is interrogated by the Proving Master/Proving Associate to verify the sign(s) &/or symptom(s) recorded by him/her in �Prover's Day Book Proforma everyday. The verified symptoms are recorded in 'Symptoms Elaboration Proforma' with complete details in respect of their location, sensation, modalities and concomitants by the Proving Master.
 
            During the course of proving, the prover is referred for specific laboratory investigation(s) to rule out any pathological cause for appearance of new symptom(s)/sign(s). Laboratory tests are performed to facilitate observation of any correlation between the subjective and objective changes during the course of proving. The opinion of the experts is also taken, on the appearance of new sign(s)/symptom(s), wherever needed.
 
  C. Resume intake of Drug
 
            After disappearance of sign(s) &/or symptom(s) developed by the drug, the prover has to wait for a further period of thirty days (washout period). If the washout period is symptom free, the prover may start intake of doses from the next quota (potency) of the drug again in the same dose schedule i.e. 4 doses/day and follow the process A and B.
 
Terminal Medical Examination (TME)
 
            After completion of proving of all potencies (quotas), the provers are examined by the specialists again, and the process is called 'Terminal Medical Examination' (TME).
 
Decoding
 
            The proved drug is decoded after receiving �Prover's Day Book Proformae, �Symptoms Elaboration Proformae, �Pathological Report Sheets and �Terminal Medical Examination sheets' from all the proving centers at CCRH headquarters before compilation.
 
Compilation
 
            The sign(s) &/or symptom(s) generated by verum (drug) or placebo (control) on each prover are noted down with prover code, name of the proving center, stage, number of doses after which each of the signs or symptoms appeared and the duration for which they persisted. The sign(s) &/or symptom(s) generated by verum group, are separated from those generated by provers of control group. The sign(s) &/or symptom(s) which were produced by the placebo as well as the drug in provers, are not taken into consideration. The sign(s) &/or symptom(s) generated by the provers kept on drug are compiled as per the schema of the Kents Repertory i.e. Mind, Vertigo, Head, Eye, Ear,Generalities.
 
  • Criteria for selection of symptoms
    1. As per the appearance of Symptoms;
    2. Selection on the basis of comparison (both intra prover and inter prover) with controls (Exactly same symptoms to be discarded keeping in view appearance in number of controls vis-à-vis verum group)
    3. Classification of symptoms as stated below
      1. (RS)- Recent symptoms i.e. a symptom that you are suffering from now, or have been suffering from in the last year.
      2. (NS)- New symptom.
      3. (OS)- Old symptom. State when the symptom occurred previously.
      4. (AS)- Alteration in present or old symptom. (e.g. used to be left side, now on the right side)
      5. (US)- An unusual symptom for you.
 
7-SAMPLE SIZE
 
    1. At least 15 provers from one centre, out of which 6 (3 males and 3 females) should be from non- homoeopathic background.
    2. Screening procedures
      1. Social desirability scale
 
8-ETHICAL CONSIDERATION
  Council's Drug Proving Programme has been duly approved and cleared by the Ethical Committee of the Council with the following observations/guidelines:
 
  [Archived image unavailable]   Safety for the volunteers is an important prerequisite in Drug Proving
       
  [Archived image unavailable]   The drug substance will be administered in potency only, which is known to provoke transient �proving" symptoms, but does not cause toxicological effects.
       
  [Archived image unavailable]   The prover should be in such a mental, physical state as to be able to exercise fully his/her power of choice.
       
  [Archived image unavailable]   The nature and purpose of the drug proving must be explained to the provers.
       
  [Archived image unavailable]   The investigator or the investigating team should discontinue the proving if in his/her or their judgement, the proving, if continued, may be harmful to the prover.
 
9-REPORTING PROFORMAE
  Since a large amount of information is obtained from a prover, the following formats for data recording will be adopted while conducting Drug Proving:
  PRE-TRIAL/ POST-TRIAL MEDICAL EXAMINATION (PME/TME) REPORTS PROFORMA (Form-D)�is for recording the state of the health of the subjects both before and after the Drug Proving trial. These proformae are to be filled in by the Honorary Consultants/incharge of the Laboratories attached to the Drug Proving Research Institute/Unit on the basis of the findings on examination of the subjects, as follows:
 
Parts of Form-D Examiner System(s) to be examined
Part –I Proving Master/
Proving Associate		 �Health status of the volunteer
Part-II Psychiatrist �Psychological Examination
  General Physician Examination of �Respiratory system,
  General Examination of �Gastro-Intestinal System,
General Examination of �Cardiac system"
Examination of �Nervous System,
Examination of �Genitalia (Male) and
Examination of �Urinary system
Gynaecologist Examination of �Genitalia (Female) and �Menstruation"
Ophthalmologist Examination of �Eye"
E.N.T. specialist Examination of �Ear and
Examination of �Nose & Throat"
Dermatologist Examination of �Skin"
Pathologist �Pathological Examination"
Part-III X-Ray
(Out sourcing)		 Chest X-Ray
 
Proformae used in Drug Proving
 
  • Provers Day Book Proforma (P.D.B.P.) - For the prover, to record the subjective symptoms or deviations, if any, from his/her normal condition(s) of life during TRIAL PERIOD, observed after the intake of the trial drug.

  • Symptoms Elaboration Proforma - To be filled in by the Proving Master/Proving Associate the details of each symptom recorded by the prover in the P.D.B.P. i.e. location, sensation, modality, concomitant & extension, etc.

  • Pathological Report Sheet - To be filled in by the Pathologist at the time of PME/TME and during the proving.
 
10. PERIODICAL REPORTS (Form-I & J)
  Monthly (Form I) & Quarterly/Annual reports (Form J) will be submitted to CCRH/New Delhi through the Incharge the Institute/Unit in the first week of the month/reporting period.
 
11- PARTICIPATION CERTIFICATE
  A participation certificate will be awarded by the Central Council for Research in Homoeopathy, New Delhi only to the students from Homoeopathic Medical Colleges, who participate in Council's proving programme fully till the conclusion of relevant drug proving programme.
 
12-ACKNOWLEDGEMENT
  Involvement of authorities of the Homoeopathic Medical College, Head of the Departments/teachers and students will be duly acknowledged for associating in the proving programme.
 
13-DATA SHARING
  Final compiled proved data (Drug Pathogenesis) of the drug would also be made available to college authorities for academic interest.
 

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