A Prospective Open labelled non Randomized phase II clinical trial on SAARANAI CHOORANAM in the management of RATHTHA KOTHIPPU (SYSTEMIC HYPERTENSION)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The outcome will be aimed at reducing the systemic hypertension. If during or after treatment systolic blood pressure below or equal to 130mmHg and diastolic blood pressure below or equal to 90mmHg it will be considered as successful outcome.
研究概览
简要总结
The study is a prospective open labelled phase II non-randomized clinical trial to evaluate the therapeutic efficacy of SAARANAI CHOORANAM in the management of RATHTHA KOTHIPPU (SYSTEMIC HYPERTENSION). The trial drug will be administered orally at the dose of 20mg/Kg/BW/Twice a day20mg/Kg/BW/Twice a day for 45 days along with Ghee / Jaggery as adjuvant in 40 patients. The trial period of 12 months will be carried out in Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli, Tamilnadu. The primary outcome will be the evaluation of therapeutic efficacy of trial drug SAARANAI CHOORANAM. The secondary outcome will be the evaluation of Siddha diagnostic parameters, aseessment of safety profile of trial drug, assessment of pharmacological and biochemical parameters of trial drug. In case of any adverse events (AE) is noticed and it will be referred to pharmacovigilance department of SCRI. Further management of patients will be given in OPD facility.
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
- 35.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient presenting with the conditions such as known systemic hypertension.
- •Stage II (≥140/ ≥90 mm/hg), AHA, Hyperlipidemia, Diabetic mellitus.
- •Type II, Choronic alcoholism, Smoking.
排除标准
- •1.Age group below 34 years and above 71 years.
- •2.Patients presenting with the following conditions, such as Known malignant Hypertension, Ischaemic heart disease, Chronic kidney disease, Chronic liver disease, Pregnancy, Lactating mother.
结局指标
主要结局
The outcome will be aimed at reducing the systemic hypertension. If during or after treatment systolic blood pressure below or equal to 130mmHg and diastolic blood pressure below or equal to 90mmHg it will be considered as successful outcome.
时间窗: 45 days
次要结局
- 1.To evaluate the pharmacological activities of trial drug.(2.Study about the prevalance of Raththa kothippu (Systemic Hypertension) in relation between diet and life style.)