Clinical trial of Parthadyarishta (Arjunarishta) and Sarpagandha Vati in the management of Essential Hypertension (Uccha Raktachap)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Changes from baseline measurements in mean sitting systolic blood pressure and mean sitting diastolic blood pressure.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •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)
- •Willing and able to participate for 14 weeks.
排除标准
- •Known clinical diagnosed cases of coronary diseases
- •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}
- •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
- •Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)
- •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.
结局指标
主要结局
Changes from baseline measurements in mean sitting systolic blood pressure and mean sitting diastolic blood pressure.
时间窗: At baseline, 14, 28, 42,56,70,84 and at the end of follow up after 14 weeks.
次要结局
- 1. Change in the SF-36-Health Survey Score.(2.Change in Hamilton Anxiety Rating Scale (HAM – A) Score)