| ORIGINAL ARTICLE |
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| Year : 2022 | Volume
: 6
| Issue : 1 | Page : 4-10 |
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Safety and efficacy of Rudraksha Churna in the treatment of essential hypertension—a single-arm multicentre trial
Vinod Bihari Kumawat1, Babita Yadav2, Ashwathykutty Vijayan2, Avinash Jain2, Jeuti Rani Das3, Bhagwan Sahai Sharma2, Shruti Khanduri2, Rakesh Rana2, Richa Singhal2, Thugutla Maheshwar2, Narayanam Srikanth2, Kartar Singh Dhiman2
1 M.S. Regional Ayurveda Research Institute for Endocrine Disorders, Jaipur, India
2 Central Council for Research in Ayurvedic Sciences, New Delhi, India
3 Regional Ayurveda Research Institute, Itanagar, Arunachal Pradesh, India
Correspondence Address:
Dr. Ashwathykutty Vijayan
Central Council for Research in Ayurvedic Sciences Headquarter, Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan, No. 61–65, Institutional Area, Opp. ‘D’ Block, Janakpuri, New Delhi 110058
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/jras.jras_50_21
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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. |
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