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Date posted: April 24, 2012

A Homoeopathic Drug Proving of Trachyspermum Ammi  and an effective protocol on how to conduct a homeopathic drug proving

Dr Ajith Kumar D S

Introduction
Homoeopathy is a specialised system of therapeutics based on the law of healing – Similia Similibus Curentur which means ‘let likes be treated by likes’.

Homoeopathy offers a life of service to humanity and it is the only method of healing that surely sets the sick person on the permanent road to recovery.

Experimentation of a drug on healthy human beings to ascertain its pathogenetic properties is peculiar to the art & science of homoeopathy. These pathogenetic recordings form the foundation and basis of Homoeopathic Materia Medica and selection of Homoeopathic similimum.

Every Homoeopathic prescription is based on a comparison between the portrait of the disease and the drug picture obtained through drug proving. The law of Similars states that any substance which can produce a totality of symptoms in a healthy human being can cure that totality of symptoms in a sick human being.

Ever since the first drug proving of CINCHONA by Dr. Hahnemann the methodology of drug proving have been improved & undergone many modifications. Hahnemann’s discovery of dynamisation of medicines is of the greatest importance to the development of the methodology of drug proving. By drug dynamisation the therapeutic virtue of crude drugs are activated, the toxicity of poisonous substances are annulled and the inert substances are aroused to activity so that the proving becomes more effective.

Proving of drugs on healthy human beings is a superior method when compared to proving on animals or sick persons. The effects of drugs on animals & human beings are different. Subjective symptoms cannot be studied in animals. An attempt to study the action of drugs on sick persons defeats its own purpose because the positive action of a drug is liable to be vitiated by the already existing disease in the organism.

Now the Homoeopathic Materia Medica is enriched with the provings of a vast number of drugs from all sources i.e. from vegetable kingdom, animal kingdom, minerals, nosodes, sarcodes, imporadablia & synthetic sources.

The plant kingdom is the largest source of Homoeopathic medicines. A continuing supply of high quality provings is essential for the progress of Homoeopathy. A good many Homoeopathic remedies are now being prepared from indigenous plants & herbs of India. The medicinal use of herbs & plants are mentioned in the Rig-Veda & widely used in Ayurvedic system of Medicine. Many of these drugs after proving on healthy human beings & used homoeopathically have found to effect magnificent cures. It is the duty of homoeopathic physician of India to make homoeopathic provings of these indigenous drugs & their by enrich our Materia Medica.

This is a humble effort made by me to homoeopathically prove Trachyspermum ammi, a well known Ayurvedic medicine which is commonly known as ‘Ayamodakam’. It is an aphrodisiac, anthelmintic, carminative & laxative. It is widely used in Ayurvedic medicine in the treatment for ascites, abdominal tumours, and enlargement of the spleen, piles, vomiting, abdominal pains, biliousness, toothache & good for the heart.

The Homoeopathic drug proving of Trachyspermum ammi helps to unfold the therapeutic virtues of the drug, so that after repeated provings & clinical verifications, it can be added to our homoeopathic Materia Medica and can be prescribed to the sick according to homoeopathic principles.

“We are here to add what we can to, Not to get what we can from, LIFE”       - William Osler 

AIMS AND OBJECTIVES 

  • To introduce a new drug (Trachyspermum ammi) into Homoeopathic Materia Medica.
  • To elicit the symptomatology of the same through Homoeopathic drug proving.
  • To substantiate the symptomatology of Trachyspermum ammi with synthesis Repertory.   

BUILDING UP OF THE MATERIA MEDICA (2, 10, 50)
If tests with a considerable number of simple medicines have thus been carried out on healthy individuals, and a careful and faithful recording of all the disease elements and symptoms that they are capable of developing is done, then only a true Materia Medica can be built up.

This will be then a collection of real, pure, reliable modes of action of simple medicinal substances, a volume, wherein is recorded a considerable array of the peculiar changes of the health and symptoms ascertained to belong to each of the powerful medicines, as they were revealed to the attention of the observer, in which the likeliness of the (homoeopathic) disease elements of many natural diseases to be hereafter cured by them are present, which, in a word, contain artificial morbid states, that furnish for the similar natural morbid states the only true, homoeopathic, that is to say, specific, therapeutic instruments for effecting their certain and permanent cure. (Aphorism 143)

From such a Materia Medica, everything that is conjectural, all that is mere assertion or imaginary should be strictly excluded. Everything should be the pure language of nature carefully and honestly interrogated. (Aphorism 144)

Of a truth it is only by a very considerable store of medicines accurately known in respect of these their pure modes of action in altering the health of man that we can be placed in a position of discover a homoeopathic remedy, a suitable artificial (curative) morbific analogue for each of the infinitely numerous morbid sates in nature, for every malady in the world. Few disease remain for, which a tolerably suitable homoeopathic remedy may not be met with among those now proved as to their pure action, which without much disturbance, restores health in a gentle, sure and permanent manner infinitely more surely and safely than can be effected by all the general and special therapeutics of the old allopathic medical art with its unknown composite remedies, which do but alter and aggravate but cannot cure chronic diseases, and rather retard   than promote recovery from acute diseases and frequently endanger life. (Aphorism 145)

We thus build a complete Materia Medica. It is to borne in mind that the daybooks are not the Materia Medica. Not until the masses of symptoms have been analyzed, sifted, classified. Hahnemann called it Materia Medica Pura, because it consisted of the collective statements of the positive and perceptible reactions of the healthy human body recorded in the words of persons acted upon by drugs and admits no misinterpretations with changing medical terminology, altered biological concepts and newer scientific developments.

TRACHYSPERMUM AMMI (6, 7, 8, 13, 26, 27, 28, 29,  30, 31, 36, 37, 46, 47, 52, 55, 56, 57)
(Carum copticum) 

SCIENTIFIC CLASSIFICATION

  • Kingdom : Plantae   – Plants
  • Subkingdom        : Tracheobionta    – Vascular plants
  • Superdivision      : Spermatophyta – Seed plants
  • Division   : Magnoliophyta   – Flowering plants
  • Class  :  Magnoliopsida   – Dicotyledons
  • Subclass : Rosidae
  • Order       : Apiales
  • Family     : Apiaceae ( Umbelliferae )
  • Genus      : Trachyspermum
  • Species    : ammi

BOTANICAL SYNONYMS
Carum copticum, Carum ajowan, Ptychotis ajowan, Trachyspermum copticum

ORIGIN
Eastern Mediterranean, maybe Egypt. The main cultivation areas today are Persia and India, but the spice is of little importance in global trade. This plant grows and is largely cultivated in Eastern India, particularly abundant in and around Indore and the Nizam’s dominions.

DISTRIBUTION: Cultivated extensively in Indian gardens, Baluchistan – also in Afghanistan, Persia, Egypt, and Europe.

EXTERNAL MORPHOLOGY
An erect annual, 0.3-.09 meter high, glabrous or minutely pubescent.

Leaves- rather distant. 2-3 pinnate, ultimate segments 1.3-2.5cm. all linear. Bracts usually many, linear, sometimes divided; bracteoles 3-5, small, linear. Rays of umbel pubescent.

Flowers -pure white.

Fruit- 2mm. ovoid, muricate, sub hispid, carpals dorsally compressed, ridges distinct; vittae solitary, small.

CHEMICAL CONSTITUENTS (6, 7, 8, 34, 36, 37, )
The essential oil (2.5 to 5% in the dried fruits) is dominated by thymol (35 to 60%); furthermore, apiece, p-cymene, limonene and a terpinene have been found. In the essential oil distilled from aerial parts (flowers, leaves) of ajwain grown in Algeria, however, isothymol (50%) was found to be the dominant constituent before p-cymene, thymol, limonene and a-terpinene. Note, however, that the name isothymol is not well defined and might refer to both 2-isopropyl-4-methylphenol and 3-isopropyl-6-methylphenol (carvacrol). (Journal of Essential Oil Research, 15,39,2003)

From South Indian ajwain fruits, almost pure thymol has been isolated (98%), but the leaf oil was found to be composed of monoterpenoids and sesquiterpenoids: 43% cadinene, 11% longifolene, 5% thymol, 3% camphor and others. (Indian Journal of Pharmaceutical Sciences, 64, 250, 2002).

A new phenolic galactoside – 3-galactosyloxy-5-hydroxytoluene-isolated from seeds along with galactose, β-methygalactoside and 2-methyl-3-glucosyloxy-5-isopropylphenol. (compendium of Indian medicinal plants: vol-4)

ANALGESIC ACTIVITY:-
Externally it is applied to relieve rheumatic and neuralgic pains. flatulent colic, Omum seeds, black pepper, ginger, each ½ drachm and cardamom 1 drachm all powered and mixed forms a useful carminative for colic etc; In cases of colic or pain in the bowels, chakradatta recommends a compound powder, made up of equal parts of Ajowan, rock salt, sonchal salt, yavakshara, and asafoetida and chebulic myrobalans. Dose is 10 to 20 grains taken with wine. 

ANTHELMINTIC ACTIVITY:-
Dose is one drachm twice daily, ‘the chief importance of Ajwon seeds is for production of thymol, which is a very valuable anthelmintic.’ – chopra. Ajowan of the variety imported from Khorasan province of Persia is good for ankylostoma; it is taken with rock salt on empty stomach early in the morning.-(Dr. Roy).

PREPARATION OF MOTHER TINCTURES
MODERN APPROACH (22, 50)   In every instance, the dry crude substance is to be taken as the starting point from whence to calculate its strength, and with very few exceptions, the mother tinctures contain all the soluble matter of one grain of the dry plant in ten minims of the tincture. [HPUS] 

STANDARD UNIT OF MEDICINAL STRENGTH (22, 50)
According to modern approach, the tinctures should be of uniform strength. While Hahnemann observed that plant moisture is a part of medicinal substance, the modern view is that the plant moisture constitutes merely as a vehicle or menstrum and forms no part of medicinal substance. In most cases of medicinal preparations, (in modern method) with the exception of few drugs, the drug strength is of uniform standard i.e.10% or 1/10 or 1X

Purpose of modern method is to avoid double standard made by Hahnemann and to secure uniformity in strength (drug power) of all preparations and attenuations; thereby making dilutions and triturations of equal degree correspond in medicinal strength.

A distinctive feature of the modern method is that, instead of using the fresh juice of the succulent plants only, it provides using of a drug substance as a whole. 

GENERAL PRINCIPLES (22, 50)
After procuring the crude drug substances, the first step will be to qualify them for medicinal use, which involves two forms or conditions, the liquid form and the solid form, i.e. the liquid tinctures solutions and the triturations.

All the drug substances soluble in alcohol, purified water or glycerine, will have to be properly made into tinctures or solutions and next their attenuations or dilutions. Aqueous mother solutions are prepared from substances which are soluble in water, but are insoluble in alcohol.

Tinctures of alcoholic solutions of solids or semi-solids are made of various varieties of drug substances, which are partially or wholly soluble in alcohol. They embrace all plants and different parts of plants, e.g., roots, stems, rhizomes, bulbs, barks, leaves, fruits, seeds, gums, resins, balsams, alkaloids etc.

Substances like camphor, iodine, phosphorus and volatile oils etc., which are volatilized on triturating, they are better prepared as tinctures.

MOISTURE CONTENT (22, 50)
Moisture content of the plant is the amount of juice contained in a plant. Fresh succulent plants and other substances containing water should be treated according to the fundamental rule that the dry crude drug is taken as the starting point from whence to calculate the strength of the tincture. Hence first take a suitable quantity of the fresh plant or part thereof and estimate the moisture content. Only the proportion of anhydrous drug is taken in calculation.

Hahnemann considered the moisture as a part of the active constituents of the plant and preparations were based on this consideration. But the strengths of the tinctures varied due to variability of moisture contained in the same plant at different times, seasons, and conditions of growth, procurement and storage. As such, moisture content or water content of each crude sample is ascertained before hand.  

Proving Director:
Dr.Esmail Sait, Principal (Rtd.)
Government Homoeopathic Medical College,  Kozhikode.
Proving Supervisor/ Coordinator/Master prover:
Dr.Ajith kumar.D.S, B.H.M.S 

Methodology

  • Data Collecting    : Diary/journal format (Prover’s Day Book Proforma)
  • Study Design        : Single group with placebo run-in
  • Method of Binding: Single-Blind
  • Controls               : Intra-individual controls, placebo run-in, placebo controls 

Medications
The medication used in this homoeopathic drug proving was prepared in the Department of Pharmacy, Government Homoeopathic Medical College, Thiruvananthapuram as liquid in 3X and 30C potencies. 

Subject Population
There were 40 subjects: 18 men and 22 women 18to 40 years. 35 subjects received the drug, 5 received placebo.

THE TECHNIQUE
The technique used in this study is Single blind Randomized control trial using crossover technique during consecutive proving of a higher potency after proving a lower potency. In the single blind randomized control trial, the person proving the drug does not know whether he is a prover or a control. Only the master prover knows whether the drug Trachyspermum ammi or placebo (as control) was given to a person considered for proving. In the crossover technique, the controls taken during the 3X proving are made as provers for the 30C potency and vice versa.

The project director of the proving program was Dr. Esmail Sait, Principal (Rtd) Government Homoeopathic Medical College, Kozhikode. He provided the directions about the program and decided upon the drug and potencies that were to be proved.

Dr. Remadevi Amma, Reader, Department of Pharmacy, Government Homoeopathic Medical College, Thiruvananthapuram supervised the drug preparation and potentisation procedures.

After preparation of the drug, I was the Investigator/ coordinator of the investigation who monitored the responses in the prover’s day book proformas. I took the cases of the provers before the proving and maintained a close contact with the provers from the start of the proving program. Utmost attention was paid towards the changes noted in the health of the provers. The provers day book was monitored every fifth day and the elaboration book was made.

SELECTION OF THE DRUG
After discussion with my guide and experts in different fields, the drug Trachyspermum ammi was selected due to its proved action in the traditional Hindu system of medicine, Ayurveda.

The pharmacognosical identification was done by the department of pharmacognosy, Ayurvedic Research Institute, Poojapura.

The alcoholic extraction of the crude drug prepared Homoeopathically by the methods of maceration in the Pharmacy Lab of Government Homoeopathic Medical college, Thiruvananthapuram.

Proving was done with standard preparation of only 3X and 30C potencies of Trachyspermum ammi. Potencies were given in clean phials, as medicated No. 40 Globules. Identical phials of globules saturated with dispensing alcohol were used as placebo. 

MOTHER TINCTURE PREPARATION

  • 100 ML of Tachyspermum ammi mother tincture was made using ;
  • 10 gm of dried Tachyspermum ammi seeds
  • 18.5 ml of distilled water(to compensate for the moisture content)
  • 81.4 ml of alcohol

The drug substance is made into a pulp (magma). The pulp was placed in a macerating jar, made of glass. 81.5 ml of alcohol (pre calculated) was added to cover the whole mass of drug substances. 18.5 ml of distilled water was added. The macerating jar was now carefully corked or sealed in order to prevent the evaporation of the menstrum(alcohol) . The jar was kept in a cool dark place, free from dust, odour, heat or direct sunlight. The temperature is better with in the range of  15 C- 20 C. The jar was kept for 2 to 4 weeks and was shaken every day.

OBSERVATIONS AND DISCUSSIONS
Forty volunteers were considered for the Homoeopathic drug proving of the new drug Trachyspermum ammi. The forty volunteers were divided into two groups ‘provers’ and ‘controls’. 22 of the volunteers were doctors, (4 – teachers & 18 – PG scholars) 16 were homoeopathic medical students and two interns. Volunteers were in the 18-40 age group and the maximum volunteers were in the20-30 age group.

The 3X was the first potency considered for proving. Of the forty people, 35 were considered under the ‘prover’ category and 5 under the ‘control’ category. The prover control ratio was 7:1.

It could be observed that the site of action of remedy mostly centered on the head, GIT, throat and skin. The main symptoms were abdominal pain, flatulence, diarrhea, heart burn, headache, pimples, throat pain, fever, joint pains, sneezing & irritability.

It could be observed that out of the thirty five people, eighteen developed abdominal pain, fourteen had pimples, eleven had headache, five had diarrhea, ten had throat pain, seven had fever, and six had joint pain & five sneezing in 3 X potency. Out of the thirty five people  nine developed abdominal pain, ten had pimples, thirteen had headache, ten had fever,  seven sneezing, seven had flatulence, four had heart burn & four had irritability  in 30C potency.

During the proving of the 30C potency, all the controls of 3X were given the 30C potency and some of the people who were in the prover category of the 3X proving were made controls. The 30C proving helped in reconfirming many of the symptoms received after the proving of 3X thus increasing the validity of these symptoms. Mental symptoms are less during the proving of  3X  potency when compared to 30C  potency.

Twenty two of the provers were homoeopathic physicians. The well described and conscientiously observed signs and symptoms confirm the fact that “Physicians are the best provers” because they already know all the facts about the proving and are very observant to the smallest changes in health occurring in the mind and body.

The master prover described a lot of symptoms thus confirming the fact that the master prover should play the part of the prover in the proving experiment. The master prover could better describe the symptomatology which he had received from the different provers while proving on himself.

The symptomatology of trachyspermum ammi could be described well through the proving of this drug by forty provers using the single blind randomized control trial technique. This new drug, Trachyspermum ammi is now introduced into the Homoeopathic Materia Medica after a thorough homoeopathic drug proving. Reproving and clinical verification of Trachyspermum ammi is to be done for proper inclusion of it into the homoeopathic Materia Medica.

After referring the symptoms to the repertory Synthesis (edition 8.1), the whole symptomatology, described after the proving of 3X and 30C potencies, is converted into rubrics and the drug is included under the corresponding rubric in the repertory. If no rubric is found corresponding to its symptom, a new rubric is formulated and is added to the Synthesis repertory edition 8.1.

CONCLUSIONS 

  • The proving of the 30C potency developed more symptoms on the mind than the 30X potency.
  • It was observed that the site of action of the remedy mostly centered on the Head, GIT, Throat and Skin. The main symptoms were abdominal pain, flatulence, diarrhea, heart burn, headache, pimples, throat pain, fever, joint pains, sneezing & irritability.
  • The 30C proving helped in reconfirming many of the symptoms received after the proving of 3X thus increasing the validity of these symptoms.
  • The symptomatology of Trachyspermum ammi could be described well through the proving of this drug by forty provers using the single blind randomized control trial technique. This new drug, Trachyspermum ammi is now introduced into the Homoeopathic Materia Medica after a thorough homoeopathic drug proving. Now a reproving and a clinical verification of the therapeutic action of Trachyspermum ammi are to be done for proper inclusion into the homoeopathic Materia Medica.

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Dr. Ajith Kumar.D.S. B.H.M.S, M.D.(HOM),
DEPARTMENT OF PHYSIOLOGY & BIOCHEMISTRY,
GOVERNMENT HOMOEOPATHIC MEDICAL COLLEGE, CALICUT, KERALA
E-mail: ajithdevarajan@yahoo.co.in
Mob: 9447051611

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