A clinical study to evaluate the effects of some Ayurvedic formulations in the management of High blood pressure.

Phase 2

Recruiting

• Conditions: Essential Hypertension

• Registration Number: CTRI/2015/03/005634
• Lead Sponsor: Central Council For Research In Ayurvedic Sciences

Brief Summary

Ayurveda Regional Research Institute, Patna, is a clinical research institute and is a peripheral institute of the Central Council for Research in Ayurvedic Sciences (CCRAS), an autonomous body under the Department of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homeopathy), Ministry of Health & Family Welfare, and Government of India and is an apex body in India for the formulation, co-ordination, development and promotion of research on scientific lines in the Ayurveda system of medicine, aimed at generating evidence for the scientific validation of the clinical efficacy and safety of classical Ayurvedic formulations. This is a single centric trial being initiated in Essential Hypertension (Uccha Raktachapa)† disease at Ayurveda Regional Research Institute (ARRI), Patna, of the Council as an activity under the Intra Mural Clinical Research Programme (IMCRP).

 Parthadyarishtha (Arjunarishtha) is  a  fermented  liquid  preparation  made  with  the  ingredients  in  the formulation containing Partha (Arjuna) (Terminalia arjuna), Mridvika (Vitis vinifera), Madhupushpa (madhuka indica),Jala (water) for decoction, Dhataki (Woodfordia fruticosa) and Guda (jaggery).

Sarpagandha Vati is prepared by air dried root of Rauwolfia serpentina.

 The present study entitled “Clinical Evaluation of Parthadyarishtha (Arjunarishta) and Sarpagandha Vati in the Management of Essential Hypertension (Uccha Raktachapa)†is being undertaken in this peripheral institutes (Ayurveda Regional Research Institute (ARRI)), Patna of the CCRAS.

 The evidence generated as an activity under the IMR programme is expected to scientifically substantiate the claims regarding clinical efficacy and safety of these classical Ayurvedic formulations.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-15
• Last Update Posted: 2016-01-13

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• Diagnosed patients of essential hypertension S.B.P. ≥ 140 Hg. and_< 159 Hg.& D.B.P.≥ 90 Hg. and _< 99 Hg mm.
• Hg (Hypertension Stage-1,as per JNC VII report,2004) 2.
• Willing and able to participate for 14 weeks.

Exclusion Criteria

• Known clinical diagnosed cases of coronary diseases 2.
• Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
• Symptomatic patients with clinical evidence of Heart failure.
• Secondary hypertension.
• 5 Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT >3 times of the upper normal limit) or Renal Dysfunction (defined as S.
• creatinine > 1.2mg/dl, uncontrolled Pulmonary Dysfunction(asthmatic and COPD patients) or other concurrent severe disease.
• 6.Patients with Diabetes Mellitus {B.S. (F) > 126 mg/dl and / or B.S. (2 hr.
• PP)>200 mg/dl} 7.
• Women who are pregnant or lactating.
• Patients on steroids, oral contraceptive pills or estrogen replacement therapy.
• Alcoholics and/or drug abusers.
• 10.Serum Triglycerides ≥ 250 mg/dl 11.Patients with evidence of malignancy 12.
• Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.) 13.
• H/o hypersensitivity to any of the trial drugs or their ingredients.
• Patients who have completed participation in any other clinical trial during the past six (06) months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes from baseline measurements in mean sitting systolic blood pressure and mean sitting diastolic blood pressure.	At baseline, 14, 28, 42,56,70,84 and at the end of follow up after 14 weeks.

Secondary Outcome Measures

Name	Time	Method
1. Change in the SF-36-Health Survey Score.	2.Change in Hamilton Anxiety Rating Scale (HAM – A) Score

Trial Locations

Locations (1)

Ayurveda Regional Research Institute Patna; 🇮🇳 Patna, BIHAR, India

Ayurveda Regional Research Institute Patna

🇮🇳Patna, BIHAR, India

Dr KK Singh

Principal investigator

kks_pat@yahoo.co.in