A prospective open labelled,single arm,non-randomized,single centric,phase II clinical trial to determine the effectiveness of Dhadimathi Kashayam in the management of Raththa Piththam(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
研究概览
简要总结
This is a prospective open labelled,single arm, non- randomized ,single centric, phase II clinical trial to determine the effectiveness of Dhadimathi kashayam in the management of Raththa Piththam (Systemic Hypertension ).The trial drug Dhadimathi kashayam is freshly prepared and will be administered at a dosage of 50ml (twice a daily before food )for 48 days for 40 known primary hypertension (20 OP and 20 IP patients ).The primary outcome will be determine the clinical efficacy of Dhadimathi kashayam (internal) in the management of Raththa Piththam (Systemic hypertension) .The secondary outcome will be collect the various siddha literatures and modern journals for literature review on Raththa Piththam.To study other cofactors related to disease like age,sex,dietary habits,family history and socioeconomic status .To perform physiochemical,phytochemical ,biochemical analysis of Dhadimathi Kashayam .To evaluate the safety profile for acute toxicity for Dhadimathi Kashayam .To evaluate pharmacological activities of Dhadhimathi Kashayam
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Known Systemic Hypertension High Normal (SBP 130-139 mmHg and/or DBP 85-89 mmHg) Grade 1 Hypertension (SBP 140-159 mmHg and/or DBP 90-99 mmHg) Grade 2 Hypertension (SBP 160-179 mmHg and/or DBP 100-109 mmHg).
排除标准
- •Known Malignant hypertension Ischemic heart diseases Chronic kidney disease Chronic liver disease Malignancy Hyperlipidemia Diabetes mellitus Smoking and Alcoholism.
研究者
DR RAM KUMAR M
Government Siddha Medical College and Hospital .