PA01.17. A clinical study to evaluate the effect of extract based herbal formulation on hypertension- a single blinded standard controlled randomized study

PURPOSE: In Ayurveda although there is no such terminology like hypertension but still this work is an approach to establish relationship between Hypertension & vitiated functioning of three governing forces of our body i.e. Tridosha and to treat Hypertension on Ayurvedic principles. The logic behind such correlation is based on the fact that, like other physiological processes, B.P. too is normal phenomenon of our body which is governed by Tridosha. After going through modern pathogenesis of primary hypertension and its symptomology, in present study it has been correlated with Vata Kaphaja Vikara with Rasavaha, Raktavaha and Manovahi Srotas as the seat of disease. Looking at its pathogenesis, the term Uccha Vyan Bala (exaggerated physiological functioning of Vyan Vayu leading to increase contractility of heart & blood vessels) can be coined for hypertension. METHOD: Subjective criteria Headache, Palpitation, Vertigo, Dyspnoea on walks and Fatigue. Objective criteria BP value recorded by sphygmomanometer in supine position. Final assessment of results; Subjective assessment 75 to 100% disappearance of symptoms effectively cured. 50 to 74% disappearance of symptoms well cured. 25 to 49% disappearance of symptoms fairly cured. 0 to 24% disappearance of symptoms poorly cured. Objective assessment Patient showing reduction in BP by 10mmHg Poorly cured; Patient showing reduction in BP between 11 to 20mmHg Fairly cured; Patient showing reduction in BP between 21 to 30 mmHg Well cured; Patient showing reduction in BP by more than 30 mmHg Effectively cured. Research methodology Type of study-Single blinded comparative study. Study site IPD and OPD department of Shubhdeep ayurved medical college, Indore (MP). Sample size 50 patients divided randomly into two equal groups. Group A given trial drug whereas Group B given control drug. Drug dosage and vehicle 1 capsule twice daily with lukewarm water after meals. Duration of treatment one month (examined at weekly intervals.) Dietary advice to strictly restrict the daily intake of Amla, Lavana, Guru & Vidahi diet. RESULT: 70% Patients found to be hypertensive were above 40 years of age. 60% Patients were fond of salty & spicy diet. Out of 50 patients 30 patients (60%) belongs to service class. Out of 50 patients 35 patients (70%) were male. Regarding prevalence of symptoms, Dyspnoea on routine work was found in 82%, Headache & palpitation in 80%, Vertigo in 78% & Fatigue in 66% patients. CONCLUSION: As per classical texts, Vata predominant diseases are caused due to vitiation of Vata due to emaciation (Dhatu Kshaya) & obstruction (Marg avarodha). Hypertension seems to be Vata predominant disease due to obstruction. Reason being that, Lavana is Vata Shamak, & should therefore decrease Blood pressure but on contrary it increases B.P. Similarly increase in weight leads to greater chances of High Blood pressure. Above discussion favours that Hypertension can be considered Vata predominant disease due to Marg avarodha by Kapha Dosha and Pitta Dosha in Anubandh. Finally it can be concluded that the drug under study has shown enthusiastic results in reducing the overall value of blood pressure. 64% patients got effectively cured, 24% got well cured and 12% got fairly cured. Regarding symptomatic relief, out of 25 patients 8 showed more than 75% relief, 9 showed more than 50% relief, 7 showed more than 25% relief and only 1 patient showed less than 25% relief in overall symptoms. No significant side effects have been reported in any subject.