MATERIAL AND METHOD:
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The Provers
As far as possible, healthy volunteers were chosen and subjected to thorough preliminary physical and clinical examination, laboratory investigations concerning blood, urine, stool and radiological examination. Only those volunteers who were found fit for the proving were selected.
Thirty provers which included adult males (21) and females (9) took part in the first proving conducted at the research unit at Lucknow (U.P.). Most of the provers were from amongst the students of the homoeopathic college where the research unit was located, only a few were from the middle age-group who were engaged in different kinds of job. The minimum and maximum age of the provers were 18 and 50 years respectively (Appendix-1).
In the second proving which was conducted at Bhagalpur (Bihar) and Midnapore (West Bengal), thirty seven provers, fifteen at Midnapore and twenty two at Bhagalpur, participated and included males (24) and females (13). Minimum and maximum age of these provers were 18 and 40 years respectively.
The findings of the preliminary examination and the symptoms peculiar to the individual prover were recorded in a pre-designed proforma (Appendix-III)
The Drug
Reliable preparations of Cassia sophera were procured from Messers. Hahnemann Publishing Co. Pvt. Ltd., 165, Bipin Behary Ganguly Street, Calcutta (West Bengal) in mother tincture, 30th and 200th centessimal potencies.
The Central Drug Proving Cell (CDPC) of the erstwhile Central Council for Research in Indian Medicine and Homoeopathy (parent organisation of the Central Council for Research in Homoeopathy) coded the drug and made separate vials containing mother tincture, medicated globules for true provers and placebo for the controls. Food colours were used to make a mild alcoholic solution resembling the mother tincture for controls.
Method Of Proving
The Hahnemannian concept of proving of drugs on apparently healthy human volunteers with modifications suggested by Drysdale. (double blind technique--wherein neither the Proving Master nor the provers knew the name of the drug) was followed through out the two provings conducted on different provers and at different places and time. It was necessiated by the fact of variations in life styles, food habits and climate in different parts of the country, and also in view of different environmental, constitutional and temperamental factors which could have a bearing on the evolution of drug pathogenesis.
The provers selected for the proving were subjected to a thorough preliminary medical examination, in order to establish their fitness for undertaking the proving. They were advised not to make any change in their daily routine with regard to sleep, exercise, bathing, meals etc. They were watched for any excess in respect of their personal habits. Any prover who made regular use of tobacco or any other stimulant including coffee and tea was advised not to take them in excess quantity. Care was taken to ensure that the provers did not use any other medicines and also camphor or seasoned food which might have possibly affected the pathogenesis, during the entire course of proving. The provers were also watched for their duration of sleep, digestive function, mental state, fatigue etc. while the proving was in progress.
Each prover was provided sufficient number of blank sheets to make record of all the signs and symptoms, subjective and objective, they experienced during the course of proving. The recorded symptomatic data were subsequently handed over to the Proving Master (technical officer in the concerned unit who conducted the proving), on their next visit.
The proving of the drug was carried out with mother tincture, 30th and 200th centessimal potencies, first in descending order i.e. starting with 200th potency. Later, after sufficient period of gap the drug was again administered to the provers, but this time in ascending order i.e. starting with mother tincture. During the entire course of proving, the CDPC maintained a strict control.
The CDPC issued instructions and directions for administration of drug separately with each quota of the drug i.e. mother tincture and different potencies. The prescribed single dose of medicated placebo globules was constituted of 4-6 globules, whereas in the case of mother tincture placebo (dilution) it was of 4-5 drops, either directly on the tongue or mixed with a table spoonful of water. The dose thus suggested was given thrice daily till such time the prover developed any morbid sign and symptom.
All the provers were initially administered with placebo in order to ascertain the genesis of placebo symptoms occurring due to psychogenetic effects. Later, in the second stage when the actual proving commenced, all the controls received nothing but placebo at all stages of proving, and those who received the coded drug continued to do so till the times they developed morbid signs and symptoms. Administration of drug was stopped immediately after the appearance of any abnormal signs and symptoms.
Each prover was summoned to the research units during the course of proving and the data recording sheet was collected. Additional information which deemed necessary in relation to the individual prover's symptomatic observations viz. location, sensation, modalities, concomitants, extension, duration etc. with regard to each sign and symptom, and also their intensity, sequence of their occurrence and recurrence was noted on the record sheets. The number of provers who developed identical symptoms was also recorded. Laboratory investigations such as pathological, biochemical etc. were also made wherever the symptoms warranted them, and the findings thereof were recorded on the record sheet just below the concerned symptom. This exercise was undertaken to determine the character and relation of symptom to each other. Whenever it was deemed necessary, services of specialist consultants were made use of to ascertain the clinical value of each sign and symptom and their observations were also recorded properly in the prover's daily record.
Thus each prover was interrogated meticulously at each of his,her visit, particularly with regard to the observations he ,she had made, and the data were recorded in detail alongside the signs and symptoms recorded by them on the record sheets. Weather, temperature, percentage of humidity etc. were also noted daily prior to the interrogation of the provers.
Data Reporting and Documentation
The data reported by the provers and as recorded by the Proving Master after interrogating the provers with regard to the location, sensation, modalities, concomitants, extension (if any) and duration of each reported symptom, and the findings of the clinical, laboratory and radiological investigations were recorded in a pre-designed proforma (Appendix-II).
Data Analysis and Compilation
The pathogenesis obtained by the Proving Master was thoroughly screened by CDPC.
The signs and symptoms which were produced by the controls were discarded. Also, such symptoms which were identical in both the provers and controls were also discarded.
Only such signs and symptoms which were distinctly experienced by prover(s) persistently at all times during the course of proving, were considered for compilation. The signs and symptoms thus compiled were arranged in schematic form as in Kent's Repertory, with minor modification.
The Provers
As far as possible, healthy volunteers were chosen and subjected to thorough preliminary physical and clinical examination, laboratory investigations concerning blood, urine, stool and radiological examination. Only those volunteers who were found fit for the proving were selected.
Thirty provers which included adult males (21) and females (9) took part in the first proving conducted at the research unit at Lucknow (U.P.). Most of the provers were from amongst the students of the homoeopathic college where the research unit was located, only a few were from the middle age-group who were engaged in different kinds of job. The minimum and maximum age of the provers were 18 and 50 years respectively (Appendix-1).
In the second proving which was conducted at Bhagalpur (Bihar) and Midnapore (West Bengal), thirty seven provers, fifteen at Midnapore and twenty two at Bhagalpur, participated and included males (24) and females (13). Minimum and maximum age of these provers were 18 and 40 years respectively.
The findings of the preliminary examination and the symptoms peculiar to the individual prover were recorded in a pre-designed proforma (Appendix-III)
The Drug
Reliable preparations of Cassia sophera were procured from Messers. Hahnemann Publishing Co. Pvt. Ltd., 165, Bipin Behary Ganguly Street, Calcutta (West Bengal) in mother tincture, 30th and 200th centessimal potencies.
The Central Drug Proving Cell (CDPC) of the erstwhile Central Council for Research in Indian Medicine and Homoeopathy (parent organisation of the Central Council for Research in Homoeopathy) coded the drug and made separate vials containing mother tincture, medicated globules for true provers and placebo for the controls. Food colours were used to make a mild alcoholic solution resembling the mother tincture for controls.
Method Of Proving
The Hahnemannian concept of proving of drugs on apparently healthy human volunteers with modifications suggested by Drysdale. (double blind technique--wherein neither the Proving Master nor the provers knew the name of the drug) was followed through out the two provings conducted on different provers and at different places and time. It was necessiated by the fact of variations in life styles, food habits and climate in different parts of the country, and also in view of different environmental, constitutional and temperamental factors which could have a bearing on the evolution of drug pathogenesis.
The provers selected for the proving were subjected to a thorough preliminary medical examination, in order to establish their fitness for undertaking the proving. They were advised not to make any change in their daily routine with regard to sleep, exercise, bathing, meals etc. They were watched for any excess in respect of their personal habits. Any prover who made regular use of tobacco or any other stimulant including coffee and tea was advised not to take them in excess quantity. Care was taken to ensure that the provers did not use any other medicines and also camphor or seasoned food which might have possibly affected the pathogenesis, during the entire course of proving. The provers were also watched for their duration of sleep, digestive function, mental state, fatigue etc. while the proving was in progress.
Each prover was provided sufficient number of blank sheets to make record of all the signs and symptoms, subjective and objective, they experienced during the course of proving. The recorded symptomatic data were subsequently handed over to the Proving Master (technical officer in the concerned unit who conducted the proving), on their next visit.
The proving of the drug was carried out with mother tincture, 30th and 200th centessimal potencies, first in descending order i.e. starting with 200th potency. Later, after sufficient period of gap the drug was again administered to the provers, but this time in ascending order i.e. starting with mother tincture. During the entire course of proving, the CDPC maintained a strict control.
The CDPC issued instructions and directions for administration of drug separately with each quota of the drug i.e. mother tincture and different potencies. The prescribed single dose of medicated placebo globules was constituted of 4-6 globules, whereas in the case of mother tincture placebo (dilution) it was of 4-5 drops, either directly on the tongue or mixed with a table spoonful of water. The dose thus suggested was given thrice daily till such time the prover developed any morbid sign and symptom.
All the provers were initially administered with placebo in order to ascertain the genesis of placebo symptoms occurring due to psychogenetic effects. Later, in the second stage when the actual proving commenced, all the controls received nothing but placebo at all stages of proving, and those who received the coded drug continued to do so till the times they developed morbid signs and symptoms. Administration of drug was stopped immediately after the appearance of any abnormal signs and symptoms.
Each prover was summoned to the research units during the course of proving and the data recording sheet was collected. Additional information which deemed necessary in relation to the individual prover's symptomatic observations viz. location, sensation, modalities, concomitants, extension, duration etc. with regard to each sign and symptom, and also their intensity, sequence of their occurrence and recurrence was noted on the record sheets. The number of provers who developed identical symptoms was also recorded. Laboratory investigations such as pathological, biochemical etc. were also made wherever the symptoms warranted them, and the findings thereof were recorded on the record sheet just below the concerned symptom. This exercise was undertaken to determine the character and relation of symptom to each other. Whenever it was deemed necessary, services of specialist consultants were made use of to ascertain the clinical value of each sign and symptom and their observations were also recorded properly in the prover's daily record.
Thus each prover was interrogated meticulously at each of his,her visit, particularly with regard to the observations he ,she had made, and the data were recorded in detail alongside the signs and symptoms recorded by them on the record sheets. Weather, temperature, percentage of humidity etc. were also noted daily prior to the interrogation of the provers.
Data Reporting and Documentation
The data reported by the provers and as recorded by the Proving Master after interrogating the provers with regard to the location, sensation, modalities, concomitants, extension (if any) and duration of each reported symptom, and the findings of the clinical, laboratory and radiological investigations were recorded in a pre-designed proforma (Appendix-II).
Data Analysis and Compilation
The pathogenesis obtained by the Proving Master was thoroughly screened by CDPC.
The signs and symptoms which were produced by the controls were discarded. Also, such symptoms which were identical in both the provers and controls were also discarded.
Only such signs and symptoms which were distinctly experienced by prover(s) persistently at all times during the course of proving, were considered for compilation. The signs and symptoms thus compiled were arranged in schematic form as in Kent's Repertory, with minor modification.
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