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Journal of Research in Ayurvedic Sciences 2022 October - December ; 6 (1) :4-10
Safety and efficacy of Rudraksha Churna in the treatment of essential hypertension—a single-arm multicentre trial
Vinod Bihari Kumawat (1), Vinod Bihari Kumawat (1), Babita Yadav (2), Babita Yadav (2), Ashwathykutty Vijayan (2), Ashwathykutty Vijayan (2), Avinash Jain (3), Avinash Jain (3), Bhagwan Sahai Sharma (2), Bhagwan Sahai Sharma (2), Shruti Khanduri (2), Shruti Khanduri (2), Rakesh Rana (2), Rakesh Rana (2), Richa Singhal (2), Richa Singhal (2), Thugutla Maheshwar (2), Thugutla Maheshwar (2), Narayanam Srikanth (2), Narayanam Srikanth (2), Kartar Singh Dhiman (2), Kartar Singh Dhiman (2), Jeuti Rani Das (4), Jeuti Rani Das (4)
1. M.S. Regional Ayurveda Research Institute for Endocrine Disorders, Jaipur, India 2. Central Council for Research in Ayurvedic Sciences, New Delhi, India 3. Central Council for Research in Ayurvedic Sciences, New Delhi, India 4. Regional Ayurveda Research Institute, Itanagar, Arunachal Pradesh, India
Abstract
BACKGROUND: Essential hypertension (EHTN) is one of the most prevalent lifestyle disorders globally. In Ayurveda, the powdered seed of Elaeocarpus ganitrus Roxb. ex G.Don [Rudraksha Churna (RC)] is indicated for headache, the most common symptom of EHTN. Pharmacological studies on an aqueous extract of E. ganitrus have shown that it can be used to treat anxiety and EHTN. However, no research has been done on the therapeutic efficacy of RC in the treatment of EHTN. Therefore, the present study was designed to evaluate the safety and efficacy of RC in the treatment of EHTN. MATERIALS AND METHODS: The multicentre single arm trial was conducted at the Regional Ayurveda Research Institutes at Jaipur and Itanagar. A total of 150 individuals who met the screening criteria were enrolled in the trial after obtaining written informed consent. The participants were administered two 500 mg capsules of RC twice daily (2 g daily) with water for 12 weeks. The outcome measures were reduction in blood pressure, improvement in Hamilton Anxiety Rating Scale Score (HAM-A), SF-36-Health Survey Questionnaire (HSQ), visual analog scale for headache, anxiety, dizziness, tinnitus, fatigue, and amelioration in clinical parameters at every 14-day interval during the trial period of 98 days comprising 84 days of treatment and 14 days of follow-up. RESULTS: The results showed a significant decrease in mean systolic and diastolic blood pressure (P < 0.001). Significant relief (P < 0.001) was also observed in outcome measures such as headache, anxiety, dizziness, fatigue, shortness of breath, palpitation, HAM-A, and HSQ score. Safety parameters such as liver function tests and renal function tests were within the reference range during the study, indicating the therapeutic safety of RC. CONCLUSION: EHTN and its symptoms can be managed with RC. However, double-blind RCTs with adequate sample size may be planned to validate the findings of this study before generalizing the study results. Keywords: Essential hypertension, Rudraksha Churna, safety, efficacy
DHARA ID: D060658
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