Efficacy and Safety of Zinc Supplementation on Blood pressure and Quality of life in patients receiving Telmisartan and Hydrochlorothiazide combination: A randomised open label study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- 1. Change in systolic blood pressure (SBP) from baseline to 12 weeks.
研究概览
简要总结
Studies have shown that zinc plays a multifaceted role in regulating blood pressure through vascular, renal, and inflammatory pathways. Also it is proven that standard antihypertensive regimens can cause depletion of zinc, therefotre it’s plausible that adding zinc supplementation could improve outcomes. Thus, comparing combination therapy of telmisartan and hydrochlorthiazide with zinc versus without zinc to evaluate if there is better blood pressure control and overall well-being.
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged between 18 to 65 years Newly diagnosed case of Grade 1 primary hypertension Systolic BP 140 to 159 mm of Hg DBP 90 to 99 mm Hg Patient is willing to come for follow up till 12 weeks Patient is willing to give informed written consent.
排除标准
- •Patient suffering with Stage 2 or stage 3 primary hypertension Patient suffering with diagnosed secondary hypertension Patients have contraindication or allergic to Zinc, Telmisartan or Hydrochlorothiazide Patient giving history of taking mineral supplement in last 3 month before enrolment Patient having history of ischemic heart disease, stroke, congestive heart failure, clinically significant arrhythmia or conduction disorders, diagnosed end stage renal disease, abnormal liver function or critically ill patient Systolic Blood pressure difference in both arms more than 10 mmHg Pregnant female Lactating mother.
结局指标
主要结局
1. Change in systolic blood pressure (SBP) from baseline to 12 weeks.
时间窗: All the patients will be asked to come for follow-up at 4, and 8- and 12-weeks post-treatment and | patients will be evaluated thoroughly for the efficacy, and safety parameters at each visit.
2. Change in diastolic blood pressure (DBP) from baseline to 12 weeks.
时间窗: All the patients will be asked to come for follow-up at 4, and 8- and 12-weeks post-treatment and | patients will be evaluated thoroughly for the efficacy, and safety parameters at each visit.
次要结局
- 1) Change in quality of life from baseline to 12 weeks.(2) Incidence, type, causality, preventability and severity of adverse effects in both)
研究者
Mini Sharma
Department Of Pharmacology