To Prove Medicines Which Are Partially Proved in

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TO PROVE MEDICINES WHICH ARE

PARTIALLY PROVED IN ORDER TO


ASCERTAIN ITS TRUE NATURE AND
QUALITIES FOR THE IMPLEMENTATION
OF SIMILIA

PRESENTED BY – DR.BHAGYAVANTI
DEPARTMENT OF REPERTORY
UNDER THE GUIDANCE OF-
DR.SUNANDA .S.
OBJECTIVES :
1. Drug proving
2. Thoroughly proved drug.
3. Characteristics of partially proved drugs. 
4. Need for reproving of partially proved drugs. 
5. Measures to be taken for reproving the drugs.
6. scope and limitations of partially proved drugs.
DRUG PROVING :

 Drug Proving is the systematic process of acquiring


knowledge of the instruments intended for the cure of the
natural diseases.

 In other words we can say that “it is the systematic


process of investigating the pathogenetic power of drug
by administering the same in to the healthy individuals of
different age and both the sexes”.
SOURCES TO ASCERTAIN THE EFFECTS
OF MEDICINES
The effects of medicines can be ascertained from different
sources, including :
  Proving on healthy human being

  Toxicological studies in animals

  Clinical experiences

 Empirical

 Chemistry and biochemistry

 Accidental poisonings
Dr. Hahnemann, also called the “Father of Experimental
Pharmacology” for developing a new principle for
ascertaining the curative power of medicinal substances, laid
the foundation of drug proving and detailed the process. He
tested 99 drugs on himself, his family and his colleagues, in
order to discover the effects of drugs on healthy individuals.
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.
The Problems in Contemporary
Provings:
 Hahnemann was, among his many skills, what we would call
today a research scientist and the provings that he conducted
were of a very high standard. Sadly not all those that
followed him were as scrupulous and many very poor
provings were conducted over the years.

 Dr J. T. Kent , in his lesser writings, chapter 9, writes “ there


is a general call for our old remedies to be reproved but
nothing has been done yet to improve any of old proving
made in early days”
THOROUGHLY PROVED :WHEN CAN A
MEDICINE BE CONSIDERED TO HAVE BEEN
THOROUGHLY PROVED

 Dr Hahnemann has explained about knowledge of


instruments and drug proving in organon of medicine from aph 106
to 145

 Explanation of thoroughly or fully proved drug in aph 135


APHORISM 135
The whole of the elements of disease a medicine is
capable of producing can only be brought to
anything like completeness by numerous
observations on suitable persons of both sexes and
of various constitutions. We can only be assured
that a medicine has been thoroughly proved in
regard to the morbid states it can produce - that is
to say, in regard to its pure powers of altering the
health of man - when subsequent experimenters
can notice little of a novel character from its
action, and almost always only the same
symptoms as had been already observed by others.
 It must have been proved on suitable persons of both sexes
of various constitution.

 Almost always the same symptoms as had already been


observed by others are exhibited during reproving.

 Symptoms most carefully recorded are complete with


regard to their location, sensation, modalities and
concomitant factors so that a complete individual picture of
drug has been established
oClinical verification is one of the important step for
confirming the symptomatology of the drug generated during
the proving of the drug on healthy human beings

oClinical confirmation of signs and symptoms observed during


proving is essential for validation of symptoms of drug and its
therapeutic application

oProvings should be done in crude and highly potentised


doses
FULLY PROVED MEDICINES
 Better-known remedies not only have more recorded
symptoms, but that there has generally been more attention
paid to accurately grading these symptoms
 Ex: sulphur, natrum mur, lycopodium.
SMALL REMEDY
The first is that the remedy in truth has a limited sphere of
action, that it engages the economy of the organism only in a
focal and limited manner

The second is that the remedy is just poorly described – having


had an inadequate proving, or known only from some limited
toxicological symptoms, or adopted into our practice purely on
the basis of clinical recommendation from the botanical or
eclectic traditions.

Commonly used small Remedies

Asculus – hemorroids
Example of partially proved drug

 Proving status of ceanothus:

 ‘Ceanothus, new jerky tea, has received but fragmentary proving’,


says Dr. J.C.Burnett of England (1879).

 ‘Ceanothus was ignored even for giving its symptoms by many


authors, including Kent in M.M.Lectures’, says Willard Ide Pierce in
‘Comparative Materia Medica’. Nash in ‘Leaders’ gives
ceanothus only one line description.

 Allen forgets to mention it in his ‘Keynotes’.

 This was all due to incomplete proving of the drug.


CHARACTERISTICS OF PARTIALLY
PROVED REMEDIES:

These drugs are not well proved. Hence their therapeutic value is not
fully known.

 Their proving mainly contains less important symptoms such as


clinical symptoms, pathological symptoms, pharmacological actions
and clinical experience of doctors. Here generals are very few.

Because of the low intensity of symptoms or lack of authenticity,


these drugs are not given in many repertories. If at all considered, they
are given in a low grade and therefore are not usually selected in the
process of repertorization. (lac can)
4. When we come to a group of similar drugs for the final selection, we omit the
rare drugs due to partial similarity, and polycrest drugs are prescribed usually.(sulp)

Only the polycrest drugs are considered as deep acting drugs.

 Our previous experience with rare remedies may not be favourable and hence we
gradually stop prescribing such drugs.

Rare remedies are considered as short acting drugs and are prescribed in lower
potencies, as they don’t usually seem fully similar to the case

Many drugs used in Ayurveda and other traditional systems are also used in our
system. When we go through the literature of these drugs, we feel the scarcity of
symptoms with which we can prescribe homoeopathically.
NEED FOR REPROVING OF PARTIALLY
PROVED DRUGS:

 Majority of homoeopathic medicines are proved long back.


 They are proved in environmental conditions which is totally
different from country.
 Extreme differences in living standard, climate, food and
mental condition of prover .
 Due to urbanization, globalization, increased level of
education status and working environment, Stress of life has
changed.
 So if proving is done now in different countries, in different
races we can get much better and bigger picture of a remedy
suiting to our environmental circumstances.
MEASURES TO BE TAKEN TO REPROVE
DRUGS
 Government institutions like CCRH should reprove the
partially proved drugs in order to ascertain their complete
powers.

Steps taken by CCRH to reprove the drugs


92 drugs have been re-proved. The proving data has been published so far in the form of books – Drug
Proving (DP) volumes, Monographs and Drug Proving articles in CCRH Quarterly Bulletins (QB) &
Indian Journal of Research in Homoeopathy (IJRH)

 EG :
ALLIUM SATIVUM,
FORMIC ACID
ALFALFA
OCIMUM XANNUM
Who ever wants to conduct reproving should follow the rules
laid down by CCRH in India
Eg :
Index of ccrh journal about drug proving

cENTRAL COUNCIL FOR RESEARCH IN HOMOEOPATHY


 DRUG PROVING
 PROTOCOL
 Generic Drug proving protocol for DP Program with sequential use of potencies in drug
 Proving CCRH DP Program protocol
 Contents
 STUDY SUMMARY.............................................................................................................................4
 1. TITLE.........................................................................................................................................6
 2. TRIAL REGISTRATION..........................................................................................................6
 3. PROTOCOL VERSION...........................................................................................................6
 4. FUNDING..................................................................................................................................6
 5. ROLES & RESPONSIBILITIES............................................................................................6
 6. INTRODUCTION & BACKGROUND..................................................................................7
 6.1 Background .........................................................................................................................7
 6.2 Rationale...............................................................................................................................8
 7. STUDY OBJECTIVE............................................................................................................8
 8. STUDY DESIGN.....................................................................................................................8
 9. METHODOLOGY.......................................................................................................................8
 9.1 Study Settings.....................................................................................................................8
 9.2 Eligibility criteria:...............................................................................................................8
 9.3 Sample size:............................................................................................................................. 9
 9.4 Proving Process...................................................................................................................9
 10. When and how to withdraw the provers .......................................................................14

 11. STUDY DURATION.............................................................................................................14

 12. PROVER PARTICIPATION TIMELINE..............................................................................17

 13. DATA COLLECTION AND MANAGEMENT....................................................................18

 14. DATA ANALYSIS..................................................................................................................19

 14.1 Qualitative analysis:....................................................................................................19

 14.2 Quantitative analysis - Dose- biological response relationship.......................21

 15. ASSESSMENT OF SAFETY................................................................................................21

 15.1 Adverse events...............................................................................................................21

 15.2 Serious adverse event:.................................................................................................22

 15.3 Causation likelihood....................................................................................................22

 15.4 Un-blinding procedure................................................................................................22

 15.5 Follow-up of provers after AE (including SAE)......................................................22

 15.6 Flow chart for Adverse event handling .........................................................................23

 16. RECORD KEEPING.............................................................................................................24CCRH DP Program protocol

 October 2014 Page 3


 17. MONITORING.......................................................................................................................24

 18. PREMATURE TERMINATION OF STUDY......................................................................24

 19. ETHICAL CONSIDERATIONS...........................................................................................24

 20. TRAINING...............................................................................................................................25

 21. PROTOCOL AMENDMENTS..............................................................................................25

 22. PUBLICATION OF STUDY RESULTS:............................................................................25

 23. ACKNOWLEDGEMENT.......................................................................................................26

 24. OPERATIONAL DEFINITIONS.........................................................................................26

 25. REFERENCES:......................................................................................................................28CCRH DP Program protocol


Double-
blind, randomized and multi-centric trials are being conducted at
the following centres

1. Dr.D. P. Rastogi Central Research Institute (H), Noida (Uttar


Pradesh)
2. Central Research Institute (H), Kottayam (Kerala)
3. Regional Research Institute (H), Kolkata (West Bengal)
4. Homoeopathic Drug Research Institute, Lucknow (Uttar
Pradesh)
5. Regional Research Institute (H), Navi Mumbai (Maharashtra)
6. Regional Research Institute (H), Gudivada (Andhra Pradesh)
7. Drug Proving Unit, Bhubaneswar [Extension Unit of
Regional Research Institute (H), Puri, Odhisa]
8. Regional Research Institute (H), Jaipur (Rajasthan)
GIVING MORE IMPORTANCE TO
INDIGENOUS PLANTS REPROVING
 Many plants like aloevera, tulsi, ashwagandha, indian gooseberry,
neem, brahmi etc which are extensively used in ayurdevic
medicine preparation should be given importance for proving and
reproving than exotic plants.
SCOPE
OF PARTIALLY PROVED REMEDIES

 Can be used as a specific.


 Easy to remember

 Used in patients where we do not get generals.

 It can be used as a palliati


LIMITATIONS OF PARTIALLY PROVED REMEDIES

 Individualisation is not possible.


 Lack of knowledge among physicians.

 Lack of importance given to native or indigenous drugs


like carica papaya,calatrophis lactum.
THAK YOU

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