Comparative Evaluation of a Herbal Formulation and Amlodipine in Essential hypertension
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- b)Giddiness (Bhrama)
研究概览
简要总结
This study is randomized control group, open label trial for efficacy of Herbal Formulation (medhya vati).The study wiill be conducted at UAU Gurukul Campus Haridwar in 40 patients. The assessment will be done on the basis of Subjective and Objective parameters. The study will be conducted at OPD/IPD level of PG Department of kayachikitsa. The results will be tabulated and statistically analyzed using appropriate tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients willing to participate in the study.
- •Patients of either sex with age between 18-70 years.
- •Patients having Hypertension between time interval of 6 months to 1 year.
- •Patients suffering from stage 1 Hypertension (SBP140-159mmHg, DBP 90-99mmHg) 5)Patients suffering from Isolated Systolic Hypertension.
排除标准
- •Patients not willing to participate in the study.
- •Patients of either sex below 18 years & above 70 years will be excluded from the study.
- •Patients having Hypertension for <6 months and >1 year will be excluded.
- •Patients of stage 2 Hypertension (SBP >160mmHg and DBP >100mmHg) 5)Patients suffering from serious comorbidities like Renal failure, Coronary Artery Disease, taking medication/drug (oral contraceptives, steroids, chronic use of NSAIDs etc…) 6)Alcoholic and/or drug abusers.
- •History of hypersensitivity to the trail drugs or any of its ingredients.
- •Pregnant /lactating woman.
- •Patients who have completed participation in any other clinical trail during the past 6 months.
结局指标
主要结局
b)Giddiness (Bhrama)
时间窗: At 1st day,10th day,20th day, and | 30th day
c)Palpitations (hriddrava)
时间窗: At 1st day,10th day,20th day, and | 30th day
a)Headache (Shiro ruja)
时间窗: At 1st day,10th day,20th day, and | 30th day
d)Breathlessness (shwasa)
时间窗: At 1st day,10th day,20th day, and | 30th day
Relief in subjective parameters like-
时间窗: At 1st day,10th day,20th day, and | 30th day
次要结局
- The objective assessment will be done on the basis of changes in clinical findings & laboratory parameters.(1)Urine)
