A randomized double arm parallel clinical study to compare the efficacy of individualized homoeopathic medicines adopting Kentian method of evaluation versus Allium Sativum mother tincture in management of essential hypertension.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Assessed by reduction in level of blood pressure.
研究概览
简要总结
Hypertension is a major public health problem and important area of research due to its high prevalence and being major risk factors for cardiovascular diseases and other complications.
This is a randomized , prospective ,double arm parallel open label study to compare the efficacy of individualized homoeopathic medicines adopting kentian method of evaluation and Allium Sativum Mother Tincture in management of Essential Hypertension .
It will be conducted in State National Homoeopathic Medical College and Hospital.
Outcome will be assessed on the basis of reduction in blood pressure and quality of life of patients will be assessed by using SF 36 Questionnaire every 4weeks.
Duration of study is 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients suffering from essential hypertension (stage I hypertension: SBP 140‑159 mmHg,DBP 90‑99 mm Hg) 2.Whose history,examination, and routine investigations revealed no evidence of obvious secondary causes.
- •3.Patient who are willing for inclusion in the study and giving consent to participate and willing for regular follow ups.
排除标准
- •1.Pregnant or lactating women with essential hypertension.
- •2.Patients with severe essential hypertension.
- •3.Patients with secondary hypertension.
- •4.Patients who require emergency medical interventions or Severe co-morbidities.
- •Simultaneous participation in other clinical studies or completion of participation in a study less than 6 months prior.
- •Patient on anti hypertensive medication.
- •Patient with autoimmune disorder.
结局指标
主要结局
Assessed by reduction in level of blood pressure.
时间窗: Every 15 days upto minimum 6 months
次要结局
- SF36 Questionnaire (By RAND) for quality of life assessment of essential hypertension patients.(Every 4 weeks upto minimum 6 months)
研究者
Dr Anjali Rai
State National Homoeopathic Medical College and Hospital Lucknow