A clinical study to see the effect of some Ayurvedic formulations in the patients of High Blood Pressure

Phase 2

Recruiting

• Conditions: Essential Hypertension

• Registration Number: CTRI/2012/05/002663
• Lead Sponsor: Department of AYUSH Ministry of Health Family Welfare Government of India

Brief Summary

Aimed at scientific validation of the clinical efficacy and safety oftwenty nine (29) classical Ayurvedic pharmacopoeial formulations, multicentreclinical trials have been initiated as an activity under the Ayurveda ClinicalTrials (ACT) project of the Ayurvedic Pharmacopoeia committee (APC) duringAugust 2010 in eighteen (18) disease conditions involving fifty four (54)M.D/PhD (Ay.) research scholars in eight (08) postgraduate Ayurveda collegesacross the country.

**Asvagandhadyarista** is afermented liquid preparation containingAsvagandha (Withania somnifera), Musali (Chlorophytum tuberosum), Manjistha(Rubia cordifolia), Haritaki (Terminalia chebula), Haridra (Curcuma longa),Daruharidra (Berberis aristata), Madhuka (Glycyrrhiza glabra), Rasna (Pluchea lanceolata),Vidari (Pueraria tuberosa), Arjuna (Terminalia arjuna), Musta (Cyperusrotundus), Trivrta (Ipomoea turpethum), SvetaSariva (Hemidesmus indicus),Krsna Sariva (Cryptolepis buchanani), Sveta Candana (Santalum album), RaktaCandana (Pterocarpus santalinus), Vaca (Acorus calamus), Citraka (Plumbagozeylanica), Dhataki (Woodfordia fruticosa), Shunthi (Zingiber officinale), Maricha(Piper nigrum), Pippali (Piper longum), Tvak (Cinnamomum zeylanicum), Patra (Cinnamomum tamala), Priyangu(Callicarpa macrophylla), Sukshma ela (Elettaria cardamomum), Nagakesara (Mesuaferrea) and Honey.

**Jatamamsi Arka** is a liquidpreparation obtained by hydro-distillation of rhizomes of Nardostachysjatamansi.

**Sarpagandha Vati** isprepared by air dried root of Rauwolfia serpentina.

The present study is being undertaken in three post graduate Ayurvedacolleges to scientifically study and validate the clinical efficacy and safetyof **Ashwagandhadyarishta,Jatamamsi Arka and Sarpagandha Vati**- classical Ayurvedic formulation. These formulations have been in usesince ages and found to be useful in treating Essential Hypertension (UcchaRaktachapa) and promoting thehealth.

The **CentralCouncil for Research in Ayurvedic Sciences (CCRAS)** is the nodalorganization to co-ordinate and monitor these trials. CCRAS has provided thenecessary infrastructure to the participating colleges, technical inputs(including the clinical trial protocols), trial drugs and training to theresearchers involved in the project.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-24
• Last Update Posted: 2012-08-05

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients of either sex aged 18 years and above.
• Diagnosed patients of essential hypertension with: S.B.P. < 159 mm.
• Hg. and ≥ 140 mm Hg. D.B.P. ≤ 99 mm.
• Hg. and > 90 mm.
• Hg (Hypertension Stage –1, as per JNC VII report, 2004) 3.
• Willing and able to participate for 16 weeks.

Exclusion Criteria

• 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.
• 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.
• Patients with Diabetes Mellitus {B.S. (F) > 126 mg% and / or B.S. (2 hr.
• PP) >200 mg% OR HbA1c> 6.5%} 6.
• Women who are pregnant or lactating.
• Patients on steroids, oral contraceptive pills or estrogen replacement therapy.
• Alcoholics and/or drug abusers.
• Serum Triglycerides ≥ 250 mg/dl 10.
• Patients with evidence of malignancy 11.
• 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.
• Any other condition which the P.I. thinks may jeopardize the study.

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, 14th day, 28th day, 42nd day, 56th day, 70th day, 84th day and at the end of follow up after 16 weeks.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

National Institute of Ayurveda (NIA); 🇮🇳 Jaipur, RAJASTHAN, India

Rajiv Gandhi Government Post-Graduate Ayurvedic College; 🇮🇳 Kangra, HIMACHAL PRADESH, India

Tilak Ayurved Mahavidyalaya; 🇮🇳 Mumbai, MAHARASHTRA, India

National Institute of Ayurveda (NIA)

🇮🇳Jaipur, RAJASTHAN, India

Prof Ajay Kumar SharmaDr Pratibha Tiwari

Principal investigator

09414250295

pasharma_jpr@yahoo.com