A randomized controlled, single blind clinical trial to investigate the beneficial effect of consumption of low sodium salts on blood pressure in healthy and hypertensive participants
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in the systolic and diastolic blood pressure
研究概览
简要总结
The study is randomized controlled, single-blind clinical trial to investigate the beneficial effect of consumption of low sodium salts on blood pressure in healthy and hypertensive participants for 4 months on 200 participants that will be conducted at single center in India. The primary outcome will be the change in systolic and diastolic blood pressure after the consumption of low sodium salts developed at CSIR- Central Salt and Marine Chemicals Research Institute. The secondary outcome will be palatability as well as the comparison of systolic and diastolic blood pressure, serum electrolytes concentration, urine protein and electrolytes concentration, heart rate and ECG after the administration of developed low sodium salts and commercially available salt in healthy and hypertensive participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Healthy participant 2 Hypertensive participant with a systolic blood pressure 140 to 180 mmHg and diastolic blood pressure 90 to 110 mmHg.
排除标准
- •1 Age below 18 years and above 65 years 2 Pregnant and lactating women 3 Prisoners 4 Psychiatric illness 5 Patients using potassium sparing diuretics and potassium supplements 6 Has known acute or chronic kidney disease.
结局指标
主要结局
Change in the systolic and diastolic blood pressure
时间窗: Four
次要结局
- Palatability of low sodium salts developed at CSIR- Central Salt and Marine Chemicals Research Institute(At baseline stage)
- Comparison of systolic and diastolic blood pressure, serum electrolytes concentration, urine protein and electrolytes concentration, heart rate and ECG after the administration of low sodium salts and commercially available salt in the healthy and hypertensive patients(After 4 months)
研究者
Dr Sunil Panjwani
Government Medical College and Sir Takhtasinhji General Hospital