Clinical research Ayurvedic Methodology

1. Introduction:

 

Ayueveda, the veda of science, has specified three natures for human body, named Vata, Pitta and Kapha. Modern Science has recently discovered that these natures are genetic. Hence, this Prakriti creates a strong base for deciding the disease and then curing it afterwards. Besides this, Herbal medicines are also a majour remedy in our traditional ayurveda medical system, espically in developing countries.

 

On the other side, Clinical research  is a systematic study of new drugs in human subjects to generate data for discovering or verifying the Clinical, Pharmacological (including Pharmacodynamic and pharmacokinetic) or adverse effects and with the objective of determining safety and efficacy of the new drug.

It has capability of evaluating the efficacy of selected simple drug, simple herbal and herbo-mineral preparations.

 

WHO not only supports the appropriate use of herbal medicines, but also encourages the use of remedies, proven safe and effective.

 

2. Clinical-research and ayurveda:

 

Ayur means “Life”

Veda means “Knowledge or Science”.

 

Similarly, Clinical- research means “Examination of scientific-study of drugs on human-beings”

 

Therefore, Clinical-research and Ayurveda are correlated, both aiming at diagnosing and treating humans’ lives.

 

 

3. Ayurvedic drug: Boon or Curse

 

Journal-of-American-Medical-Association (JAMA) has recently published findings of a study, performed by JAMA on 14 commercially available Ayurvedic medicinal products sold in the Boston area. These findings indicate that one of 5 ayurvedic Herbal-Medicine-Products (HMP) produced in South-Asia contain lead, mercury and arsenic above permissible-levels. Hence, JAMA claimed that users of ayurvedic-medicines may be at risk of heavy-metal-toxicity. These findings highlight importance of mandatory testing of ayurvedic HMPs.

 

Moreover, Canadians banned the use of some ayurvedic drugs as these had high content of lead, arsenic and mercury. Toxic effects of lead, arsenic, mercury and other element may cause serious hazards to body. For e.g. Lead may cause abdominal pain, weakness, insomnia and kidney damage. Mercury can cause memory loss and brain and kidney damage, thereby deteriorating human health.

 

Hence,  while preparing any ayurvedic drug, it should be well checked with respect to the quality and quantity of various raw materials used in it such as metals, herbs etc.

 

4. Ayurvedic drugs, more research and development needed:

 

The WHO has published guidelines in order to define basic criteria for evaluating the quality, safety, and efficacy of herbal medicines aimed at assisting national regulatory authorities, scientific organisations and manufacturers in this particular area (WHO, 2000). Furthermore, the WHO has prepared pharmacopoeia monographs on herbal medicines and the basis of guidelines for the assessment of herbal drugs (WHO, 1999, 2001).WHO guidelines for Good Clinical Practice (GCP) are adapted from ICH guidelines.

The WHO guidelines on good agricultural and collection practices (GACP) for medicinal plants are an important initial step to ensure good quality, safe herbal medicines and ecologically sound cultivation practices for future generations.

Though the experience obtained from the traditional use of herbal medicines over the years should not be ignored, most of these still need to be studied scientifically. In today’s world, the rational use and development of herbal medicines will be further supported by appropriate scientific studies of these products.

 General considerations that should be kepk in mind while defining and evaluating the herbal medicinal research are:

-> Legal research,

-> Ethical research

-> Research on humans and animals,

->Respect for environment, and

-> Traditional knowledge of herbal medicines.

 

Moreover, following are the principles (based on traditional principal such as Ayurveda) and techniques that should be considered while conducting research on herbal medicines:

->Rregulatory requirments,

-> Purpose of research,

-> Selection of research projects,

-> Research approaches,

-> Knowledge of complete literature background,

-> A carefully planned protocol, and

-> The quality of plant material

 Additionaly, general pharmacological investigations are conducted to explain various pharmacological activities. Such investigations usually cover the tests on nervous, cardiovascular and respiratory systems etc.

 Systemic toxicity tests can be performed. These tests refer to alteration of either physiology, anatomy (gross or microscopic) or clinical chemistry (including haematology) that results from pathological changes in any organ distant from the site at which a herbal medicine is administered.

 Local toxicity tests can be performed to determine the local irritation and/or systemic absorption of a herbal medicine used for local applications (such as respiratory inhalants, drugs applied to skin or mucosa).

Hence, it is crucial that all the above factors are integrated and a strategic approach to validate Ayurveda into a globally acceptable and viable complementary healthcare system ensuring drugs’  safety and efficacy be developed. This will benefit millions of patients, to whom modern medicines have not been able to provide adequate relief from ill-health.

 

All these issues need to be addressed by the Ayurvedic industry along with academic research laboratories involved with this system of medicine. Though, due to the nature of the system and its products, it would not be possible to harmonize the system among all producers of Ayurvedic drugs and make them usable by all practitioners of Ayurveda, it is necessary that at least:

è    convincing evidence of quality, efficacy and safety should be there

è    types of patients should be noted down, on whom these drugs are to be used

è    diseases noted down for which these drugs are used,

è     dosage recommendation is mentioned,

è     duration of treatment is mentioned, and

 

other such  important considerations that have a bearing on the toxic effects of these drugs, are provided for all products marketed for human consumption.

 

 

5. Clinical-research on ayurvedic-therapeutics

 

If ayurvedic-therapeutics has to compete with new chemical-entities and biotechnology-products, it must focus on utilizing principles and practices of modern clinical- trials, using herbal medicine.

Clinical trials, which are conducted in four phases should be scientifically sound, and should be described in a clear and detailed protocol. These clinical trials of herbal medicines may have two types of objectives.

è    To validate the safety and efficacy that is claimed for a traditional herbal medicine.

è    To develop new herbal medicines, examine a new indication for an existing herbal medicine and change dose formulation or route of administration.

In some cases, trials may be designed to test the clinical activity of a purified or semi-purified compound derived from herbal medicines.

Globally, there is an increasing interest in Ayurveda as an alternative route to health. Hence, there is a need to conduct globally acceptable clinical research in ayurvedic therapeutics (AT). Some of the issues in investigating AT in randomized clinical trials (CT) are:

·        Selection of appropriate AT

·        Identification of objective outcomes

·        Devising adequate placebo/positive controls

·        Duration of trials

·        Number of patients

·        Dose optimization, etc

5. Conclusion:

 

As we have seen the ill effects of ayurvedic drugs in the section ’ boon or curse’, we should realize that to ensure more quality of ayurvedic drugs, it is necessary that more research and development is done in ayurvedic medicines. If we can accurately check each drug during its making, we can greatly reduce the negative effects of such drugs. To implement the same and reduce the poisonous nature of these drugs, it is required that more research is done in this field using modern techniques.   

To communicate Ayurvedic effectiveness and curative-properties to world, Ayurveda needs more research and development. Hence, I strongly believe that Clinical-research with ayurveda, will take ayurveda to new heights of success.

 

BIBLIOGRAPHY

1. Guidelines for the assessment of herbal medicine programme on traditional medicine. Geneva: World Health Organization, document, 1991 (WHO/TRM/91.4).

2. Guidelines for reproduction studies for safety evaluation of drugs for human use. Bethesda, MD: U.S. Food and Drug Administration, 1966.

3. 1990 Guidelines for toxicity studies of drugs manual/editorial supervision by New Drugs Division, Pharmaceutical Affairs Bureau, Ministry of Health and Welfare. Tokyo: Yakuji Nippo, 1991.

4. Clinical research on new drugs (traditional Chinese medicine). Beijing, China: Ministry of Public Health; Bureau of Drug Policy and Administration, 1989.

5. Proposed WHO guidelines for good clinical practice (GCP) for trials on pharmaceutical products WHO drug information 1992. 6(4) 170-188

Safe Pregnancy and Motherhood

Abstract: Safe motherhood ensures that all women should receive social and medical

care, so that they remain protected and healthy throughout the pregnancy period. It is

also important to seek the advice of a skilled birth attendant such as a doctor, nurse or

midwife, so that they can give proper and timely advice about hygiene and health related

issues when baby is about to be born. In Ayurveda, Kashyap Samhita discusses in details

about pregnancy, childbirth and childhood. Besides, Charaka and Sushruta have also

given emphasis on these features. An early stage treatment of various pregnancy disorders

such as vomiting, pre-eclamptic toxemia, eclampsia, fever, constipation, anemia, jaundice,

diarrhea etc. with the help of different ayurvedic methods leads to a safe and healthy

pregnancy. These disorders can also be avoided by using ayurvedic management including

medication described in Garbhani paricharya during each and every gestational month.

 

Keywords:  Safe pregnancy, Safe motherhood, Ayurveda, Kashyap samhita, Gestational month, Garbhani paricharya.

 

Introduction

Most often in a developing country, each minute of every day, a woman dies from complications related to pregnancy. For all women who die, 30 to 50 percent of women suffer from injury, infection, or other complication. Almost 15% complications of these are life-threatening and require immediate obstetric care. Hence, safe motherhood can be achieved by providing high-quality maternal health services to all women during pregnancy, childbirth, and during the postpartum period.

Maternal mortality

Most of the maternal mortality is due to following major medical causes:

1. Severe bleeding (hemorrhage);

2. Infection;

3. Unsafe abortion complications;

4. Hypertensive disorders of pregnancy; and

5. Obstructed labor.

Warning signs during pregnancy:

1. Failure to gain weight (at least 6 kilograms should be gained during pregnancy)

2. Anemia or paleness inside the eyelids (healthy eyelids are red or pink)

3. Unusual swelling of legs, arms or face

4. Movement of fetus being either very little or not at all.

Therefore, a pregnant woman needs to be checked at a clinic or health facility at least four times during every pregnancy. It is also important to seek the advice of a skilled birth attendant (such as a doctor, nurse or midwife), about where the baby should be born. A pregnant woman should also be properly educated so that she can take care of herself and her baby.

Still, a pregnant woman is susceptible to all those possible diseases which a normal human being can encounter. Hence, if there is any disorder during pregnancy, the situation can be best managed under the guidance of good physician.

Considering the above facts, in Ayurveda, Kashyap samhita has given two full chapters on this subject. Harita samhita has enlisted emaciation, nausea, vomiting, edema, fever, anorexia, diarrhea and discoloration etc. According to Sushruta samhita, pregnant women are prone to facial paralysis. Similarly Charaka samhita and Vagbhata also have suggested that the pressure caused by growing fetus increases in cases of piles and edema.

According to Charaka (C. 1000 B.C.), pregnant woman should be treated with soft, sweet, cold drugs, dietetics and gentle pleasing behaviour. She should not be given emetics and purgatives.

 Exercise and use of pungent drugs should be avoided (Charaka Sutra sthan 25/40).

According to Harita(10-12^th Cent. A.D.), unripe fruit of Bilva (Aegle marmelos Corr.) mixed with curd and sugar is always beneficial.

There are certain diseases whose treatment at the initial stage itself prevents them from becoming major disorders at a later stage. Treatments of such diseases are mentioned below:

 

Line of treatment in different gestational month:

During fourth month of pregnancy:  In this, if woman suffers from any disease of vata, retention of urine, pain etc. then castor oil with milk should be given (Kashyap khil sthan, 10).

During fifth month: Evacuative enema and nutritive enema containing sour, salty drug and sweet substance should be given (Kashyap khil sthan, 10).

During sixth month: In case of lymphadenitis, furunculous, inflammation, abscess, use of cauterization and surgery should be done (Kashyap khil sthan, 10).

During seventh month: If there is protuberant flesh then its suppression should be done with help of surgery or cauterization (Kashyap khil sthan, 10).

General disorder during pregnancy and their management:

1. Vomiting:

The vomiting related to pregnancy is classified as simple vomiting of pregnancy (milder type) and

Hyperemesis gravidarum(severe type). Slight vomiting is common in early pregnancy (about 50%). It may however, occur at any time in day, generally occurs in morning. It does not produce any impairment of health or restrict the normal activities of women and gets disappeared with or without treatment by 12-14 weeks of pregnancy.

It could be managed by avoiding fatty and spicy foods. Patient is advised to take plenty of fluids (2.5l in 24hr.) and fruit juices.

Hyperemesis gravidarum is severe type of vomiting of pregnancy which has got deleterious effect on the health of the mother in day to day activities. The etiology is obscure but the following are the known facts:

 

-It is mostly limited to first trimester.

-It is most common in first pregnancy.

-It has got a familial history.

-It has more prevalence in hydatidiform mole and multiple pregnancies.

-It is more common in vata vaigunya, non-fulfillment of dauhrida stage (i.e. non fulfillment of desired substance by mother during pregnancy)

Management:

To correct the fluids in body and other metabolic disturbance.

Nutritional support should be given with rich balance diet.

Nursing care: sympathetic but firm handling of the patient is essential.

Some useful drugs:

Paste of Dhanyaka (Coriandrum sativum Linn.) mixed with rice water and sugar should be given (Yogratnakar, Stri rog chikitsa sthan).

Flour of parched barley mixed with decoction of Sunthi (Zingiber officinale Rosc.) and Bilva (Aegle marmelos Corr.) (Yogratnakar, Stri rog chikitsa sthan ).

.

2. Pre-eclamptic toxemia: It is a multi system disorder of unknown etiology characterized by development of hypertension to the extent of 140/90mm Hg or more with proteinuria after the 20^th week. It may appear even before 20^th week as in case of hydatidiform mole and acute poly hydramnios.

Demonstration of pitting edema over the ankles after 12hr. bed rest, rapid gain in weight of more than 1lb a week or more than 5lb a month of pregnancy may be earliest evidence of pre-Eclampsia.

There is increased association of pre-eclampsia with primigravida, family history, placental abnormalities, genetic disorder and thrombophilias.

Management:  As long as the etiology is obscure the treatment is mostly empirical and symptomatic.

Diet should contain adequate amount of protein (about 100gm). Usual salt intake and fluids is not restricted. Total calories approximate 1600 cal/day.

In favorable cases, there is fall of blood pressure and weight with subsidence of edema. Urinary output increases with diminishing proteinuria, if previously present.

In unfavorable cases, the definitive treatment of pre-eclampsia is termination pregnancy through which mother could be saved.

3. Eclampsia:

Pre-eclampsia when complicated with convulsion and /or coma is called as eclampsia. The causes of cerebral irritation leading to convulsion are not clear. The irritation may be provoked by anoxia (spasm of the cerebral vessels following hypertension). Cerebral edema may also contribute to cerebral irritation, arrhythmia which increases following anoxia / edema.

Management:

Patient should be placed in a railed cot in an isolated room.

Anticonvulsant and sedative regime should be used.

4. Fever:

Fever to pregnant women is most troublesome disease and fetus also suffers due to transfer of heat of fever from the mother. If fever occurs before 4^th month then patient should be advised to fast for one day, followed by use of drinkables free from fat and salt. She should take only rice gruel followed by cereals with soups and no medicine should be given. Lekhan karma (the measures which makes the body light) could be used if it occurs after 4^th month (Kashyap khil sthan,10).

In taruna jwara (recent fever), massage with oil, nasal drops and sternutatory drugs (causing sneezing) should be avoided as they influence the fetus by making it stiff or immobile (Kashyap, khil sthan 10/18).

Similarly emesis produces fetal abnormalities, abortion and other serious disorders (Charka, siddhi sthan 2/9).

General treatment:

Decoction of Chandan (Santalum album Linn.), Sariva (Hemidesmus indicus R.Br.), Lodhra (Symplocos racemosa Roxb.) & mardvika (Vitis vinifera Linn.) mixed with sugar should be given. (Yogratnakar, Stri rog chikitsa sthan).

Hriberadi decoction prescribed for diarrhea is also beneficial (Kashyap, khil sthan.10).

5. Diarrhea during pregnancy:

Dietetic abnormalities, use of ripened fruits and polluted water, fear, grief etc. psychological trauma, emaciation and due to doshas or other body disease can cause diarrhea to anybody. However during pregnancy presence of least abnormalities may produce diarrhea.

Management:

Digestive drugs should be prescribed when diarrhea has sufficient quantity of mucous in feces and constipation drug should be prescribed incase feces do not contain mucous.

Kalyanakawaleha and Hriberadi decoction is beneficial in all types of diarrhea (Kashyap, khil sthan.10).

6.  Epilepsy:

In this, incidence of fetal malformation and still birth increases. The malformation includes- cleft lips/palate, mental retardation, cardiac abnormalities, limb defect. There is chance of neonatal hemorrhage. There is also a risk of developing epilepsy to the offspring of an epileptic mother.

Management:

-Juice of lemon mixed with vid and rock salt.

-Decoction of agnimantha (Premna mucronata Roxb.)

-Soups of meat of quail mixed with fat.

7. Jaundice:

When the serum bilirubin level exceeds 2mg % (normal being .2-.8mg %), visible yellow staining of the tissue appear. Its overall incidence in India is 1-4% per 1000 deliveries.

It may be due to severe pre-eclampsia, eclampsia, acute fatty liver (acute yellow atrophy of the liver), severe hyperemesis gravidarum, intra hepatic cholestasis is the second most common cause of jaundice in pregnancy, the first one being the viral infection.

Management:

-Decoction of prsniparni (Uraria picta Desv.), bala (Sida cordifolia Linn.) and vasa (Adhatoda vasica Nees) should be given (Yogratnakar, stri rog chikitsa sthan).

-Use of pippali (Piper longum Linn.) and root of ankotha (Alangium salvifolium Linn.f.) mixed with juice of horse dung and curd of buffalo’s milk is beneficial (Kashyap, chikitsa sthan. 2/6).

8. Heart pain:

In 32^nd week of pregnancy the pressure on heart is highest and with time it goes on increasing. In such cases, the patient needs special care.

We may use powdered pippali (Piper longum Linn.) with paste of patra (Digitalis purpurea Linn.), coca ( Coffea arabica Linn.) and priyangu (Callicarpa macrophylla Vahl.) mixed with juice of lemon(Citrus medica Linn.). (Kashyap, khil sthan.10).

9.  Tuberculosis:

The incidence ranges between 1-2% among the hospital deliveries in the tropics, and is predominantly confined to the under privileged sectors of society. Incidence of T.B. is also rising worldwide with the rising prevalence of HIV infected patients, positive family histories etc. Alcohol addiction and intravenous drug abuse are also responsible for this.

Management:

- An electuary made with maricha (Piper nigrum Linn.), bharngi (Clerodendrum serratum Linn.), and pippali (Piper longum Linn.) mixed with lemon juice should be given (Kashyap, khil sthan.10).

- If it is associated with trauma then use of an electuary made with madhuka (Glycyrrhiza glabra Linn.), sankhapushpi (Convolvulus pluricaulis Chois.), jiva (Leptadenia reticulate W. & A.), sugar and honey should be used (Kashyap, khil sthan.10).

- Pippalyadi leha is also useful (Kashyap, khil sthan.10).

10. Anemia:

It is the most common hematological disorder that may occur during pregnancy. According to standard laid down by WHO, anemia in pregnancy is present when the hemoglobin concentration in the peripheral blood is 11gm/100ml or less. During pregnancy, plasma volume expand (maximum around 32^nd week) resulting hemoglobin dilution, which result in fall of hemoglobin concentration.

Due to anemia pre-eclampsia, recurrent infections, heart failure at 30-32 week of pregnancy and preterm labor may happen.

General treatment:

1. A realistic balance diet rich in protein and vitamin is prescribed.

2. To improve the appetite and facilitate digestion, some drugs could be given, such as use of powder of pippali, pippalimula (root of Piper longum Linn.), mustak (Cyperus rotundus Linn.) with sweetened milk or honey. (Kashyap, Chitiksa sthan. 2/13)

3. Effective therapy to cure disease contributing to the cause of anemia.

 

Special therapy:  The principal is to raise the hemoglobin level to normal as far as possible. Thereafter an attempt is made to restore the iron reserve, before the patient goes in labor.

11. Acute pain in abdomen:

Some amount of abdominal pain is common during pregnancy.  In approximately 80% of women who are pregnant, back pain is present. The etiology of pain is probably related to a combination of mechanical, metabolic, circulatory, and psychosomatic and social contributing factors. The fact that one-third of the patients who experience pain starting during the first trimester when mechanical forces are not a significant force, highly indicates that the most probably cause is due to a change in hormonal influence. Patients are instructed to avoid excessive weight gain; exercise to strengthen the back muscles, maintain correct posture and wear sensible shoes (not high heels).

Pregnancy is one of the most beautiful aspects of womanhood. Each pregnancy, each child born, is a special opportunity for a woman to discover within herself great strength and flexibility. She can discover her great power yet her ability to surrender, her great compassion yet a detachment, most importantly, her greatest capacity to love.

In conclusion, considering all the disorders and their management mentioned above, it can be advocated that if the fetus and the pregnant woman are taken care of during each of the nine months, we can not only control all the possible disorders but can also help both mother and her child to live a healthy and happy life.

Reference:

1. Charaka Samhita: Charak Samhita of Agnivesh, Elaborate by Charak, redacted by Drdhabala   (vol.-1), Edited with  ”Vaidyamanorama”, Hindi Commentry Along with Special Deliberation etc. by Acharya Vidyadhar Shukla and Prof. Ravi Dutt Tripathi, Forward by Acharya Priy Vrata Sharma, Chaukhamba Sanskrit Pratishthan, Delhi, (2002).

2. Dutta D.C.: Text book of Obstetrics, 6^th Edi., New Central Book Agency (P) LTD., Calcutta, (2004).

3. Tewari PV: Ayurveda Prasutitantra Evam Striroga, (Part 1) PrasutiTantra (Obstetrics), by Prof. (Km.) Premvati Tewari, Chaukhambha Orientalia, Varanasi (2003).

4. Tewari PV:  Kashyap Samhita, (1 Ed.), Chaukhambha Viswabharati Prakashan, Varanasi (1996).

5. Harita Samhita: Harit Samhita,”Hari” Hindi Commentry by Pandit HariharPrasad Tripathi, Chaukhambha Krishndas academy, Varanasi (2005).

6  Sushruta samhita: Susruta Samhita of Maharsi Susruta, Edited with Ayurveda-Tattva-Sandipika, Hindi Commentary, Scientific Analysis, Notes etc, by Kaviraja AmbikaDutta Shastri, A.M.S.(Part-1) Chaukhambha Sanskrit Sansthan, Varanasi, (2004).

7  Yogratnakar : Yogaratnakara with ”Vidyotini” Hindi Commentry by Vaidya Laksmipati Sastri, Edited by Bhisagratna Brahmasankar Sastri, Chaukhambha Prakashan, Varanasi (2008).

8. Kashyap samhita: The Kashyap samhita or (Vrddhajivakiya Tantra), by Vrddha Jivaka, Revised by Vatsya, With Sanskrit Introduction, By Nepal Rajaguru ”Pandit Hemaraja Sarma”, with The ”Vidyotini” Hindi Commentary and Hindi Translation of Sanskrit Introduction  by Ayurvedalankar, ”Sri Satyapala Bhisagacharya”, Chaukhambha Sanskrit Sansthan, Varanasi (2008).

9. Vaghbata: A. Astanga Hrdayam of Srimad Vagbhata, Edited with ”Nirmala” Hindi Commentary, along with special delibration etc. By Dr. Brahmanand Tripathi, Chaukhamba Sanskrit Pratishthan, Delhi (2007).

B. Astanga Samgraha with Hindi Commentary (Vol.1) by Kaviraj Atrideva Gupta Vidyalankar, Bhishagratna. Foreword by Rajvaidya Pandit Sri NandaKishor Sharma, Bhishagacarya, Chowkhambha Krishnadas Academy, Varanasi (2005).

From:-

Dr. Vandana Sharma (BAMS & NDDY)

Medical Officer

For good health.

In Ayurveda, Skin is Updhatu (i.e. secondary tissue) of Raktdhatu (blood), therefore glowing skin is result of good quality of rakth, which is result of eating healthy food. For most of us, food is meant to be only for satisfying hunger. But in Ayurveda, clarity of food helps in purifying the inner self and nourishes the body, which results in creating good mind and spirit.

Today, more and more people are being attracted towards fast-foods, eating anything preferred as ‘tasty’ food in the roadsidestalls, restaurants, etc.Junk foods should be avoided in our daily diets. Non food additives such as synthetic colors, synthetic flavorings, preservatives, and synthetic oils found in margarine, can add toxins to the body, overload mucous membranes, and hence, weaken the immune system.

So, overall we found tht, eating healthy food will not only result in good health but also help in gaining good, healthy and glowing skin.

 

The main pricipal of ayurveda relaise in the fact that our body is made up of five elements earth, water, fire, air and sky. Balance of these is necessary for good health. We should follow a good and healthy lifestlye. Early to bed and early to rise, to take natural food instead of ready made food. One should do meditation and yoga daily to keep mind, soul and body healthy. These are the simple measure which can be done regularly to make ourself fit and fine.