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Research on Posology

The rasa, guna, virya, vipaka and prabhava (factors that decide drug action) are known for all ayurvedic herbs. However, the rasa, guna, virya, vipaka and prabhava of combinations of herbs remain unknown. These five-fold characteristics of major combinations of herbs can be determined by studying the contributions of the Arab physician Al-Kindi. Yakub ibn Ishaq al-Sabah al-Kindi (A.D. 800-866) was the first Arab philosopher. He is considered to be a “Renaissance man” of the Arab world, centuries before the Renaissance happened in Europe. Al-Kindi’s most important work on medicine was De Medicinarum Compositarum Gradibus Investigandis Libellus (The investigation of the strength of composite medicines). The treatise is all about posology, a branch of medicine, which al-Kindi practically invented for dealing with dosages of drugs. Before al-Kindi there was very little scientific study on this subject. In this book he describes all kinds of medicines that physicians used to cure various ailments at the time. Finding out the dosages of these medicines was a guessing game in those days (Abboud 2006).

Using brilliant deduction, al-Kindi applied mathematical calculations to the earlier w'ork on degrees of warmth and coldness of drugs done by Galen (A.D. 131-201). He formulated an easy- to-use table that pharmacists could refer to when writing prescriptions. If a drug was to be neither warm nor cold, then he would add one-part warm ingredient and one-part cold ingredient, finally cancelling out any warmth. If the formulation was to have first degree of w'armth, the drug mixture should contain two-parts w'arm to one-part cold. For the second degree of warmth, three-parts warm were added to one-part cold, and so on. By documenting amounts of drugs with a formula which anyone could follow, al-Kindi revolutionized medicine. Drugs could now be formulated according to fixed amounts, with the result that all patients would receive standardized dosages of medicines (Abboud 2006). Compound ayurvedic formulations can be administered w'ith precision once their rasa, guna, virya, vipaka and prabhava are known.

Research on Rasaśāstra

While mainstream Ayurveda uses only herbs for the preparation of medicines, there is a distinct stream of Ayurveda which employs metals, minerals and animal products along with herbs. Rasousadhi (minerallo-metallic preparations) have the three characteristics of instant effectiveness, requiring only very small doses and extensive therapeutic utility, irrespective of constitutional variation in patients. The 8th-century Buddhist sage Nagarjuna is said to have perfected this system (Savrikar and Ravishankar 2011). It is significant that classical Ayurveda texts like Caraka Samhita, Susruta Samhita, Astdngasamgraha and Astdhgahrdaya do not discuss rasasastra.

Western medicine considers mercury inherently toxic, its toxicity not being due to the presence of impurities. Compounds of mercury are known to cause permanent damage to brain and kidneys (Anonymous 1999). However, exponents of rasasastra consider mercury, arsenic, zinc, tin, lead, antimony, sulfur and so on as valuable medicinal substances, if treated in the proper way. Rasasastra texts describe various elaborate procedures of sodhana (detoxification-cum-potentiation) (Jagtap et al. 2013a).

Some studies have been carried out to determine the toxicity of calcined powders of metals and minerals. Jagtap et al. (2013b) studied the toxicity of tamra bhasma (calcined powder of copper) using non-detoxified copper and detoxified copper. Tamra bhasma prepared from non-detoxified copper caused pathological effects on several hematological parameters and cytoarchitecture of different organs, even at therapeutic dose level of 5.5 mg/kg. However, Tamra bhasma prepared from detoxified copper was found to be safe even at doses five times higher than the therapeutic dose (27.5 mg/kg). These observations lend scientific evidence for effectiveness of the process of detoxification recommended in rasasastra texts.

57c//? Makardhwaj is a rasasastra formulation prepared from gold, mercury and sulfur. The safety of this preparation was reported by Kumar et al. (2014). They reported that Sidh Makardhwaj administered for 28 days, at doses five times higher than the human dose, did not show any toxicological effects on brain cerebrum, liver and kidney of rats. Svarria bhasma, another calcined powder of gold was also found to be safe in a 90-day toxicity study carried out in Wistar rats (Jamadagni et al. 2015)

Nevertheless, not all rasasastra medicines are free from side-effects. Naradlya LaksmTvilasa Rasa is an ayurvedic medicine used in tablet or powder form, prepared with mica, mercury, sulfur and 13 herbs. It is used in the treatment of sinusitis, chronic skin diseases, diabetes and urinary tract disorders (Anonymous 1978c). Hasan et al. (2016) studied the toxicological effects of this formulation following administration for 32 days. It was observed that this medicine increased the weight of heart, lungs, liver, kidneys, spleen and testes. The authors inferred that Naradlya LaksmTvilasa Rasa should not be administered chronically in higher doses.

It is believed that the aims of sodhana procedures are removal of physical and chemical impurities, minimization of toxicity of the substance, transformation of the hard and non-homogeneous material to a soft, brittle and homogeneous state, conversion of the material to a suitable form for further processing and enhancement of therapeutic efficacy of the drug (Jagtap et al. 2013a). However, further investigations are required to confirm this. As minerallo-metallic preparations have the inherent danger of toxicity, they need to be used with extreme caution.

Objective Way of Teaching Ayurveda

Ayurveda is taught at present solely with the help of the Sanskrit texts and without making use of figures, tables, flowcharts or diagrams which make learning easier. Instead of encouraging them just to memorize Sanskrit quatrains, students should be taught Ayurveda objectively. Concepts like prakrti (constitution) and dbsakopam (enragement of dosas) should be taught with the aid of practical classes. At present, in examinations, the knowledge of a student is judged on his ability to recite Sanskrit quatrains correctly. Instead of that, their skill in identifying prakrti of individuals and assessing the degree of dbsakopam should be evaluated. Greater emphasis should be given to identification of symptoms and signs. When students are taught Ayurveda in a progressive way, they will be able to diagnose diseases on the basis of ayurvedic principles.

Diagnosis of Diseases

Considering the fact that the human organism is a part of the cosmos, Ayurveda insists upon the need to examine minutely ten factors for effective diagnosis and treatment of diseases (Kumar 1992). They are briefly described below.

I. Physiological constitution (prakrti)

The concept of prakrti has some similarities with the Greco-Arabic concept of mizaj (Ahmer et al. 2015). Ayurveda considers mainly seven types of prakrti (vide supra). As individuals belonging to each prakrti are susceptible to diseases arising out of the destabilization of the corresponding component(s) of tridosa, knowledge of prakrti helps in the selection of food, measures and medicinal substances that are to be adopted to promote the steady state of tridosa (Upadhyaya 1975c).

II. Tissue elements (dhdtu)

An intelligent practitioner can accurately gauge the state of dhatu cycle by correlating symptoms and signs with the dhatu, mala and tridosa.

III. Digestive efficiency (agni)

Metabolic activities of the human body are regulated by the omnipresent fire (agni) which, for the sake of convenience, is classified into 13 varieties. The ingested food is first digested by the abdominal fire (jadharagni), followed by five bhUtagni (fires of the pahcabhiita), one agni assigned to each bhUta present in matter. The essential products of digestion enter the dhatu cycle, each step of which is catalyzed by a dhatvagni corresponding to each dhatu (Upadyaya 1975c).

Ancient authorities of Ayurveda considered jadharagni as the prime regulator of metabolism. It is classified into four types depending on the intensity. Visamdgni (irregular fire) is observed in conditions related to increased vata. Predominance of pitta gives rise to tiksndgni (sharp fire). Manddgni (dull fire) results from the influence of kapha and samagni (regular fire) is experienced by individuals in whom there is steady state of tridosa (Upadhyaya 1975b).

IV. Temporal aspects of tridosa (kalam)

The tridosa exhibit circadian and circannual rhythms. Day and night start with kapha and end with vata, the intermediate period being characterized by pitta (Upadhyaya 1975b). Similarly, the tridosa fluctuate during the seasons of the year (Upadhyaya 1975h). The temporal aspects of tridosa are to be considered in diagnosis, selection of medicines and time of their administration.

V. Age (vayah)

If the life span of an individual is divided into three equal parts (childhood, adulthood and old age), the first part will be dominated by kapha, followed by pitta and vata respectively (Upadhyaya 1975b). The age of the patient helps the physician to decide the dosage of medicines and to make a prognosis.

VI. Physical strength (balam)

The season of the year and the age of the individual, by virtue of their tridosa- modulating qualities, alter the physical strength and so does the adoption of food and measures (Upadhyaya 1975i). The constitutional and temporal aspects of balam are to be considered in the selection of such food and measures which help the body to regain health.

VII. Place of residence (disam)

Depending on climatic and geographical features a land (desam) is divisible into jangala (arid), dnftpa (wet, marshy, sylvan) and sadharana (mixed) varieties. Vata is predominant in the first one and kapha in the second. The third type is favorable for the maintenance of a steady state of tridosa (Upadhyaya 1975b). The type of place of residence has its own clinical importance. For example, if a vata disease manifests in one individual each of the jangala and dnupa areas, the drug should be administered to the former in the medium of clarified butter and the latter should receive only a plain decoction.

VIII. Homologation (satmya)

Getting used to food, drinks and measures is called satmya (homologation). Unwholesome victuals and measures will be injurious in the long run, even though they do not evoke any immediate adverse effects. The habits and addictions of a patient need to be understood for achieving homologation. The patient should achieve homologation through food, measures and medicines that bring the tridosa to steady state (Upadhyaya 1975j).

IX. Food (ahara)

Ayurveda states that the physical and mental characteristics of a person are influenced by the type of food consumed. Consequentially, proper dietetics is essential to cure diseases and to maintain health (Upadhyaya 1975k).

X. Emotional status (satvam)

Fear, anxiety and other psychological stresses cause disease and aggravate them. The patient is therefore, expected to be optimistic and fearless to undergo treatment (Upadhyaya 1975b). Adequate counseling should be given to the patient for adopting a positive outlook.

However, in contemporary ayurvedic practice, diseases are diagnosed exclusively on the basis of Western medical jargon and technology. As ayurvedic theory correlates qualities of matter, seasons, symptoms of diseases and several other factors with vata, pitta and kapha, introduction of any new parameter into ayurvedic practice calls for establishing its relationship with the tridosa. For example, clinical data obtained through instrumental techniques like spectrophotometry, electrocardiography, electromyography, computed tomography scan and the like are to be rationally correlated with tridosa before they are integrated into Ayurveda. However, as such an exercise seems to be a difficult task in the light of the present state of affairs, it will be more appropriate to use only the parameters of Ayurveda in the diagnosis of diseases. There are nearly 2500 distinct symptoms described in Astdhgahrdaya. A wise physician should collect as many symptoms as possible through darsana (observation), sparsana (palpation) and prasna (interrogation). Thereafter, he should classify these symptoms at the levels of tridosa, dhatu, mala, sadkriyakala (the six stages of development of a disease), pUrvariipa (premonitory symptoms and signs), avarana (envelopment) and the various diseases described in Ayurveda. Such a diagnostic approach will help the medical world to look at disease entities described in Western medicine through the Ayurveda perspective, offering the possibility of identifying lines of ayurvedic treatment for many refractory diseases. Western medical knowledge and investigation technology can be employed for evaluating the success of ayurvedic diagnosis and treatment.

Clinical Research on Ayurvedic Medicines

Ayurveda advocates specific protocols in the treatment of diseases. Medicinal preparations in several dosage forms, medicinal food and therapeutic measures are used in the process. However, almost all clinical studies on Ayurveda are carried out without considering the individualization of therapy, which is a salient feature of Ayurveda. For example, seven studies have been reported on the ayurvedic treatment of rheumatoid arthritis (Park and Ernst 2005). Nevertheless, none of them dealt with classical ayurvedic treatment of rheumatoid arthritis or allowed individualization of therapy. They used fixed combinations of the same formulations throughout and did not individualize the therapies. As a result, these studies show that ayurvedic treatment is ineffective (Kulkarni et al. 1992; Sander et al. 1998; Chopra et al. 2000).

The treatment of respiratory diseases (Svasahidhma cikitsa) described in Astangahrdaya would serve as an example of individualized therapy. As the first step in the treatment, the patient is to be smeared with an appropriate oil mixed with powdered rock salt. Thereafter, he is to be given a bath in warm water. The kapha lodged inside the channels of the body get loosened and reach the alimentary canal. After sudation, the patient should consume unctuous food mixed with soup prepared with fish and meat of animals from water-logged terrains. After that, mild emetic medicine is to be administered to facilitate vomiting. The emetic should contain fruits of Piper longum, rock salt and honey. Kapha from the body will come out along with the vomitus and the patient will feel great relief. This is to be followed by inhalation through nose of the smoke emanating from powdered leaf of turmeric (Curcuma longa), root of Ricinus communis, dried grapes and heartwood of Cedrus deodara, all rolled into wicks, dipped in clarified butter and burnt. Fomentation of thorax and neck with sweetened warm milk, warm water, various medicinal oils and crude herbs will bestow further relief. As the final step in therapy, the patient is to be administered with appropriate decoctions (e.g., Dasamiilakatutrayam), electuaries (e.g., Agastya rasdyanam, Kamsahantaki) and medicated clarified butter (e.g., Amrtaprasam ghrtam, Rasnadasamula ghrtam) (Upadhyaya 19751). This shows that therapy needs to be individualized and that a one disease, one medicine approach is not favored in Ayurveda.

Controlled double-blind studies of classical Ayurveda have not been conducted so far because of the lack of placebos for the traditional, individually varied, dosage forms and therapeutic measures of Ayurveda. A novel study using placebos was reported for the first time by Furst et al. (2011a). Six placebos, appearing identical to the traditional dosage forms for classical ayurvedic treatment of rheumatoid arthritis, were employed. They included decoction, powder, pills, electuaries, asava- arista and medicinal oil. The placebos were shown to effectively double-blind the trial (Furst et al. 2011b).

Forty-three seropositive rheumatoid arthritis patients with disease duration of less than 7 years were assigned to groups like methotrexate plus ayurvedic placebo, Ayurveda plus methotrexate placebo, or Ayurveda plus methotrexate. The ayurvedic physician had full freedom to prescribe any combination of medicines and therapies for all patients, based on his clinical judgment. Therefore, the patients received individualized therapy according to true ayurvedic precepts. All patients were not expected to receive all the dosage forms or corresponding placebos. But they were dispensed verum or placebo depending on their particular treatment group assignment. Forty ayurvedic formulations were used. After 36 weeks of therapy the success of treatment was evaluated using the Disease Activity Score (DAS28-CRP) (van Gestel et al. 1999), American College of Rheumatology 20/50/70 criteria for clinical improvement (Felson et al. 1995) and Health Assessment Questionnaire- Disability Index (Lubeck 2002).

All groups were comparable at baseline in disease characteristics. All three treatments were approximately equivalent in efficacy. There were no significant differences among the three groups on the efficacy measures. The methotrexate groups, however, experienced more adverse events than the Ayurveda group. This study shows that double-blind, placebo-controlled, randomized studies are possible when testing classical ayurvedic medicines against medications of the Western medical system, in a way acceptable to both Western medicine and Ayurveda (Furst et al. 201 la).

 
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