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The disease Amlapitta has been selected for the clinical trials because it presents two type of manifestations depending upon the involvement of Agni (Ushnagunadhikya) and Jala (Dravagunadhikya) Mahabhuta. The present research work was focused at Drava Guna, with an aim to assess the efficacy of a drug with quality of Ruksha and Ushna predominance like Bhringaraja in treating Amlapitta with Pitta Drava Guna Vriddhi. Randomized open clinical trials were conducted on 22 patients of Amlapitta who were screened on the basis of clinical findings and allocated in to two groups. The criteria for selection were the signs and symptoms of Dravagunadhikya Amlapitta, irrespective of sex, religion, etc. Group A consisting of 15 cases received the trial drug Bhringaraja tablet (4 Tab. two times, 1 tablet=500 mg) and 7 cases in Group B received rice powder tablet as a placebo (4 Tab. two times, 1 tablet=500 mg) for 4 weeks. Special scoring pattern was adopted for the assessment of Amlapitta. Routine pathological tests such as blood, urine, stool, etc. were also carried out. In Group A, 55.33% patients showed marked improvement, whereas moderate improvement was observed in 26.67% patients. Complete cure was found in 06.67% of the patients and mild improvement in the chief complaints was observed in 13.33% patients. All the selected symptoms showed statistically significant results (P<0.01) except the Vidbheda in treated Group A, while in Group B, all symptoms showed statistically insignificant results except the Utklesha and Amlodgara. Total effect of the therapy showed statistically significant effect of the test drug. These results support the hypothesis
Amlapitta is a very common disease in the society and is an abnormal pathological condition of Pitta. Drava Guna plays an important role in the pathogenesis of Amlapitta. On the basis of predominant Rasa and Gunatmaka diet consumed by the patient, one can visualize two types of Amlapitta (Vikalpa Samprapti) and thus can plan the therapeutic intervention [Figure 1]. If Nidanas (diet) are Amla–Lavana–Drava–Snigdha–Ushna dominant in nature, then Drava property of Pitta increases, and if Nidanas are Katu–Ushna–Ruksha dominant in nature, Ushna and Ruksha properties of Pitta get increased.
The present study was carried out to evaluate clinically Ruksha and Ushna drug, i.e. Bhringaraja, in countering the Drava Bahula Amlapitta, thereby suggesting a fundamental approach based line of treatment for Amlapitta.
This study was carried out with the following aims and objectives:
Patients satisfying the above criteria were selected from the OPD/IPD of Department of Basic Principles, I.P.G.T. and R.A., G.A.U., Jamnagar.
Patients were divided into two groups.
The test drug and placebo used in this study were mentioned in Table 1 with their details.
Laboratory investigations were carried out before and after treatment to rule out any other pathological conditions as well as to record any specific change brought about by the treatment.
Placebo-controlled randomized clinical trial was done. Informed written consent was taken from the patients before including them in the trial. An elaborative case taking proforma was specially designed for the purpose of incorporating the disease and Drava Guna concept.
Pathyapathya (wholesome–unwholesome diet): Patients were advised to take Pathyahara and to correct their dietary habits and avoid Apathyahara as per the classical guidelines.
Relief in signs and symptoms of Amlapitta was assessed by B.T. and A.T. gradation of clinical features, on the basis of scoring pattern.
The overall assessment based on relief from the symptoms is shown in Table 2.
The information gathered on the basis of observations was subjected to statistical analysis. Chi-square test and Student's paired “t” test were carried out for all subjective parameter (symptoms). Student's paired “t” test was applied for the objective parameters like hematological and biochemical investigations. The results were interpreted at P<0.05, P<0.01 and P<0.001 significance levels. Total effect of therapy was calculated with the help of Chi-square test.
In the present study, 42 patients of Amlapitta [Table 3] were evaluated. It was found that 42.86% patients were in the age group of 31–40 years [Table 4], which is Pitta Dosha dominance stage of life. This finding correlates with the findings of Iyer Shividya, Prof. R. R. Dwivedi et al. (2003) and Santosh Mane, Prof. R. R. Dwivedi et al. (2008). At this particular age, strenuous work, traveling, dietetic incompatibilities like Vishamashana, ignorance about Dinacarya, etc. are the other factors that set a solid foundation for Pitta disorders due to vitiation of Agni. Maximum (i.e. 69.04%) patients were taking Snigdha, Ushna, Guru, Drava diet like oily substance, spicy food which contains Snigdha as well as Ushna Guna [Table 5]. The symptoms exaggerated in 76.12% patients in relation to oily, spicy diet [Table 6]. These observations of the two tables indicate that Snigdha–Ushna Gunatmaka diet provokes the Drava Bahula Amlapitta which is in accordance with Madhukosha commentary view that Snigdha and Ushna are Hetu for Pitta Drava Vriddhi.
Maximum patients (80.95%) were habituated with improper diet styles like Samashana, Vishamashana and Viruddhashana [Table 7]. From this point of view, it can be said that for the manifestation of disease Amlapitta, all the above factors may be responsible collectively as well as individually. As per Acharya Sushruta, these are the most important factors in creating the Agnimandya. However, the role of these factors in increasing Pitta Dravata is still not clear. It can be inferred that Samashana, Vishamashana and Viruddhashana which includes Snigdha and Ushna Gunatmaka diet may be the reason for increase in Pitta Dravata.
On examining the Shareera Prakrti, it was observed that maximum (i.e. 35.72%) patients prone to this disease were of Kapha–Pittaja and Kapha–Vata Prakriti. This shows the tendency of Kapha Pitta predominance leading to Dushti of Annavahasrotas and ultimately producing its symptoms earlier than others [Table 8]. In Amlapitta, Pitta is the leading vitiated Dosha and Kapha is next to Pitta. Kapha and Pitta both have the Drava Guna. Hence, Pitta and Kapha Prakriti persons are more prone to the disease, Amlapitta, as Drava Guna of Pitta increases in Amlapitta.
In this study 88.09% patients were having Avara Jarana Shakti [Table 9]. Pachaka Pitta is responsible for digestion. In normal condition, Pachaka Pitta is devoid (i.e. a smaller amount) of Drava Guna. If Drava Guna of Pachaka Pitta increases, then it decreases Ushna Guna of Pachaka Pitta which is the most essential Guna for digestion. In Amlapitta, due to increase in Drava Guna and decrease in Ushna Guna of Pitta, Avara Jarana Shakti was observed. This is in accordance with the classical view that if Drava Guna of Pitta increases, then it hampers digestion by creating Agnimandyata.
Maximum patients (i.e. 57.14%) had been suffering from Amlapitta since more than a month [Table 10]. This indicates Chirakari Swabhava of Amlapitta. 83.33% and 9.05% of the patients were taking Guru Bhojana and Viruddhahara, respectively, while 38.10% of the patients were taking Atisnigdhahara [Table 11]. This % of Aharaja Nidanas [Table 11] directly indicates their role in Amlapitta. Annavaha and Rasavaha Srotas involvement was seen in all of the patients (i.e. 100%) [Table 12]. This observation supports the classical view of Kashyapa which indicate Rasa Dhatu as the main Dushya in Amlapitta.
In Group A (Bhringaraja treated), 100% relief was observed in Chhardi symptom. Next to Chhardi, maximum 85.71% relief was observed in Kandu/Kotha, followed by 83.33% in Angasada and 80.56% in Amlodgara. Utklesha was reduced by 79.31%, while Klama and Avipaka improved by 78.26% and 76.92%, respectively. 70.97% relief in Guru Koshthata and 66.67% in Aruchi were observed. Placebo (Group B) drug showed maximum 52.94% improvement in Amlodgara and 50% improvement in Chhardi. It also showed improvement in Utklesha by 42.11% [Figure 2].
Use of placebo control excludes the psychological and environmental factors affecting the treatment efficacy. Hence, results obtained in Group A are due to the drug efficacy and not due to the effect of psychological and environmental factors.
Statistically highly significant result (P<0.01) was obtained in symptoms like Utklesha, Amlodgara, Avipaka, Guru Koshthata, Aruchi, Angasada, Klama, Kandu under Group A. Significant result (P<0.05) was obtained in Gaurava symptom, while nonsignificant result was obtained in Vid Bheda in Group A [Table 13]. Statistically nonsignificant result was obtained in symptoms like Avipaka, Gaurava, Guru Koshthata, Aruchi, Angasada, Klama, Vid Bheda in Group B, while statistically significant results (P<0.05) were observed in Utklesha, Amlodgara symptoms [Table 14]. This may be due to Nidana Parivarjana and Pathya followed by patients.
This illustrates that test drug Bhringaraja is efficacious insignificantly in improving the above individual symptoms [Table 15]. Small sample size and variation of symptoms, i.e. all the symptoms not being present in each patient, may be the reason behind the insignificant results obtained with Chi-square test.
It is evident that the Bhringaraja treated group showed statistically significant increase (paired “t” test) in four parameters: Hb (gm%) (P<0.001), total red blood cell count (TRBC; ×1012/l), packed cell volume (PCV; %), and serum glutamate oxaloacetate transaminase (SGOT) [Table 16].
It can be inferred that statistically significant increase in Hb (gm%) (P<0.001), TRBC (×1012/l), PCV (%), and SGOT cannot be directly correlated with the Drava Guna concept. But as all these parameters can be included in Pitta Varga, it can be said that Bhringaraja has positive correlation with Pitta. Increase in these parameters can be taken as increase in Agnimabhutatmaka portion of Pitta. It is a hypothetical explanation which requires further logics to prove it. As there is no statistically significant increase or decrease in parameters like serum cholesterol, low density lipoprotein (LDL), and Total Leukocyte Count (TLC) which are considered as Kapha Varga parameters, it can be said that Bhringaraja has not that much effect on Kapha Varga parameters. The test drug did not cause abnormal deviation (out of normal physiological limit) in parameters but helped to maintain them within normal limits (e.g. statistically significant increase in SGOT was observed, but it was within normal range).
Moderate to marked (summation of moderate+marked) improvement was observed in more than 80% and 14.29% of patients in groups A and B, respectively, when data were presented in percentage improvement method [Table 17]. 80% and 14.29% values distinctly show the efficacy of Bhringaraja in contrast to placebo.
Group A (Bhringaraja administered) showed statistically highly significant effects on chief complaints as compared to placebo [Table 18]. This indicates that though nonsignificant results were obtained when the symptoms were looked at separately, Bhringaraja showed increased efficacy when the overall effect was considered.
In Amlapitta, Drava Guna of Pitta gets increased leading to pathogenesis. If Drava Guna increases, for reducing it one should use drugs which have opposite properties to that of Drava Guna (according to Samanya-Vishesha Siddhanta). Bhringaraja, the selected drug, has opposite properties (like Ruksha–Ushna) to that of Drava Guna, by means of which it is able to reduce increased Drava Guna and its actions. As per the classical view, Ruksha Dravya (like Bhringaraja) can reduce Dravata. Ushna Virya Dravya (like Bhringaraja) can reduce Dravata of Grahanistha Sama Pitta. Bhringaraja has both these properties, i.e. Ruksha and Ushna Virya. That is why Bhringaraja is capable of reducing Drava Guna of Pitta in Amlapitta. Drava Guna is a Jalamahabhuta property, while Bhringaraja is Agnimahabhuta dominant drug. Hence, Bhringaraja is supposed to decrease the Drava Guna, which has been verified clinically on Drava Bahula Amlapitta patients. The present research is helpful to study a different aspect of Amlapitta with emphasis on Drava property of Pitta Dosha. The data support the findings of previous research done at Tata Memorial Hospital, which suggest Jeerna Amlapitta as the predisposing disease factor responsible for Cancer of esophagus caused by consumption of excess Amla (sour), Lavan (salty), Ushna (hot), Snigdha (unctuous) dominant diet. These factors increase the Drava property of Pitta and may indeed lead to dreadful diseases.
The above explanation proves that Bhringaraja has efficacy in treating the Drava Bahula Amlapitta in comparison to placebo. Bhringaraja can give moderate to marked improvement in Drava Bahula Amlapitta patients. Statistically significant results observed in Group A (Bhringaraja) specify that the applied concept of Drava Guna plays an important role in the pathogenesis of disease. Hence, Bhringaraja having Drava opposite properties, i.e. Ruksha–Ushna, can be a choice of remedy for the physician while treating diseases of Pitta Drava Guna Vriddhi like Amlapitta.
The authors would like to acknowledge the authorities of I.P.G.T. and R.A., Jamnagar, for providing facilities for the study.