Source: https://hpathy.com/homeopathy-papers/comprehensive-study-harmonization-methodology-homoeopathic-pathogenetic-trial-ccrh-lmhi-hpus-ech-ecch/
Timestamp: 2019-04-19 18:21:04+00:00

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Introduction: Hippocrates, Paracelsus and etc. mentioned the ‘Law of Similia’ before Hahnemann, but none of them proceeded systematically to offer an experimental proof. Dr. Hahnemann established experimental human pharmacology by proving drugs on healthy human beings. He obtained data on the pure effects of drugs which he recorded in his ‘Chronic Diseases’ and in the ‘Materia Medica Pura’. The human Drug-Proving (pathogenetic trial) is not conducted to such an extent that it would produce irreversible pathological changes. The pathological data/symptoms recorded in Homoeopathic Materia Medica chiefly belong to clinical observations, supported by reports of accidental poisoning and a few valued animal proving. Thus Homoeopathic Materia Medica is essentially a register of human functional pathology made by man for humans.
In order to enhance symptoms of Materia Medica and /or confirm existing symptoms with its amplitude, drug proving is one of the fundamental tools in the homoeopathic field. Since the inception of Homoeopathy, considerable manpower was used in different countries, including India to conduct or participate in human pathogenetic trials. From daily experiences drug proving protocol has been modified accordingly from time to time. In the relevant perspective comparison has been made and a comprehensive table is given below for ready references.
[*1] Locations of the study- Should be multi centric in plane, sea coast and mountain/hilly area to eliminate or include circumstantial influences on developing pathogenetic effects.
[*2] Age – Above 18 years of age. The prover must be young .[Ref -2, §145, FN 106,p-212] ;.[Ref -4,p-200] between 18 to 40 , to avoid bodily degeneration due to aging factor.
[* 3] Controls – Among above said authorities CCRH is holding provision for 30% control which is very much justified from a statistical analysis point of view. In a CCRH protocol regarding control, it is noted under criteria for selection of symptoms as ‘same symptoms to be discarded keeping in view appearance in number of controls vis-a-vis verum group’. Sometimes it may happen that control groups are also narrating some symptoms and it is better that it not be discarded but will be listed separately and kept in a different category, mentioning them as developed in control group for further retrospective study .
[*4] Potency and Dose- Regarding potency, Richard Hughes in his book A Cyclopedia of Drug Pathogenesy stated that “ IX- Include symptoms reported as coming from attenuation above the 12th decimal only …” . [Ref -5, p-xiii] Any potency above 12th Decimal is justified for all practical purposes.
‘ ….even though the experimenter had observed, a considerable time previously, the spontaneous occurrence of similar phenomena in himself. The reappearance of these during the trial of the medicine only show that this individual is by virtue of his peculiar constitution, particularly disposed to have such symptoms excited in him. In this case they are the effect of the medicine; the symptoms do not arise spontaneously while the medicine that has been taken is exercising an influence over the health of the whole system, but are produced by the medicine. [Ref -2, §138, ,p-207].
So apart from the development of new symptoms, if anything happens like above, that may be noted and counted as the pathogenetic effect of that medicine.
Single dose administration of chronic medicine may produce symptoms to sensitive provers; for that we have to observe the phenomena. ‘if the first dose administered shall have been sufficiently strong, the prover express the symptoms in such a way, the order of succession of the symptoms and can note down accurately , the Genius of the medicine’[Ref -2, §130, ,p-202-203]. ‘Same medicine for successive dosage may produce several symptoms but we do not ascertain Genius….’ [Ref -2, §131, ,p-203] . So, during experiment one quota may be sacrificed to have the genius symptom of medicines if it develops in any prover.
[*5] Categorization of Symptoms- In the CCRH protocol regarding this point Title is ‘Criteria for selection of symptoms’. Instead of that Categorization of Symptoms is a more appropriate term that may be coined.
After qualifying PME, participants should begin to take notes about any deviation of health both in mental and physical level seven days prior to taking medicine. Some drug symptoms appear with tolerably uniform regularity in each of the several provers, others appear rarely and with only isolated provers.
Mental symptoms : The range of enquiry is not desirable in the perspective of a predetermined field, but all symptoms in the realms of mind, intellect and body are to be noted and documented . Apart from Form G, a separate elaboration sheet (Form) for noting mental symptoms is necessary.
1. As per the appearance of Symptoms , the symptoms which appeared last in the proving are of the great value’- Hering, confirmed by Boenninghausen [Ref -1 ,p- 185] these symptoms to be categorized , and may be taken into consideration for clinical verification with priority.
i. (RS)- Recent symptoms i.e. a symptom that you are suffering from now, or have been suffering from in the last year.
ii. (NS)- Symptoms which are experienced as new, never experienced before.
iii. (OS)- Old symptom. State when the symptom occurred previously.
v. (US)- An unusual symptom for you.
Some drugs may produce alternating symptoms and may be noted as [ALS] which is very rare and characteristic of the drug [ALS] and should not be confused with alternating side of affection from left to right as stated in existing CCRH protocol noting (AS).
As through PME, the prover has to be selected, recent symptoms(RS) that anyone suffering for a long time does not arise [vide exclusion criteria], likewise as there was no existing symptoms, so chances of cure are not relevant (CS) during proving.
During proving any old symptoms may reappear for several reasons and may be noted with (OS) separately with detail of their progress and cessation. If retrospective anamnesis reveals that OS is the result of the phenomena that has taken place during proving, that should be noted as reactive power (RPM) of the medicine under trial.
Rare, peculiar symptoms developed rarely in very sensitive idiosyncratic prover are to be noted as (IRS), and may have qualitative value in clinical application.
[*6] Adverse event [AE]- Any untoward medical occurrence in a volunteer administered a proving substance and which does not necessarily have a causal relationship with the action of the substance. An adverse event (AE) can therefore be any unfavourable and unattended sign, symptom or disease temporally associated with the administration of a proving substance, whether or not related to it. If it took place that is to be noted in a separate page as AE .
[*7] Adverse effects /Drug Reaction, ADR] : In homeopathic drug provings a conventional Adverse Drug Reaction will not occur, because there are no toxicologic effects of the proving substances, since they usually are administered in high dilutions. In the existing protocol there is no citation regarding adverse effects which are likely to be caused by the administration of the proving substance and adversely affects the well being of a volunteer, disturbs the normal daily routine and may require the withdrawal of the volunteer from the homeopathic drug proving. If it took place that should be noted in separate page as ADR.
Adverse Proving Symptoms [APS]: Any untoward medical occurrence in a volunteer administered a proving substance and which necessarily have a causal relationship with the action of the substance that endangers volunteer’s life and health but not any outcome of toxicity. Any adverse proving symptoms (APS) can therefore be any unfavourable sign, a symptom associated with the administration of a proving substance. If it took place, that may be noted in a separate page as APS .
Sensitivity trial: A small amount of its dose should be taken and every change which occurs after it be observed before going for proper trial [Ref -2, §108, FN 93,p-191] to avoid adverse effects that may take place in selected cases.
Research personnel should not be confused by the term ‘Adverse effects [Drug Reaction]’ with ‘Adverse event’. Since Homeopathic Drug Provings are done with only non-toxic dilutions of a proving substance, it is very unlikely to have serious adverse drug reactions. Though it is very unlikely to happen but only in case of a severe adverse event, the volunteer has to be withdrawn from the trail.
[* 8] ‘Stop’ proving – If a good result occurs, drug administration will be suspended, but if slight response takes place, add a few more globules[Ref -2, §129, ,p-202].This does not mean withdrawal from the trial. Apart from voluntarily withdrawal, in any circumstances that demands medical intervention, proving is to be discontinued. If any extraordinary circumstances,shock, vexation, a fright, or severe external injury takes place during experiment[Ref -3, p-2] proving should be discontinued.
Language of Symptoms recorded: For the sake of being able to trace back a proving symptom to its ultimate origin, it must be kept in original language and wording of the volunteer, who experienced it. How it could be feasible to reach this goal with respect to translations has to be discussed. But, it should be discussed so that the sentences out of which the proving symptoms have been collated will at least be documented in their original wording by the director of the proving.
Boenninghausen’s Characterstics Materia Medica & Repertory- C M Boger , Published by B.Jain (p) Ltd. New Delhi 2002.
Hahnemann S – Organon of Medicine 6th edn, translated by W.Boerick, published by B.Jain (p) Ltd. New Delhi.
Hahnemann S- Materia Medica Pura ( Vol-I), published by B.Jain (p) Ltd. New Delhi.
Kent . J.T- Lectures on Homoeopathic Philosophy, published by B.Jain (p) Ltd. New Delhi.
Richard Hughes- A Cyclopedia of Drug Pathogenesy, Vol-I, published by B.Jain (p) Ltd. New Delhi.

References: §145
 §138
 §130
 §131

v. 
 §108
 §129