An open Label, Single arm Clinical Study to Evaluate the efficacy of Shuddhi Dr. B P Care Tablets in patients having Hypertension
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Change in the Systolic and Diastolic Blood pressure
研究概览
简要总结
An Open Label, Single arm clinical study.
Patients will be assigned to investigational product for 6hrs, following up on T30min, T1hr, T2hr, T3hr, T4hr, 5hr, T6hr.
On day 1, Blood pressure is monitored at T0min(Pre), and post T30min, T1hr, T2hr, T3hr, T4hr, 5hr, T6hr to check the instant action of the investigational Product.
Subjects will be enrolled based on their Systolic and diastolic range. The Asessments will be done on different timestamps are-
Subject Global Assessment, Blood Pressure Measurement and Heart Rate
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject from 18-50 years of age.
- •Subject having BP range less than 180-120 or 100-109 will be eligible for enrollment.
- •Subjects that are able to give written informed consent in a manner approved by the institutional ethics committee and comply with the requirements of the study.
- •Subject willing to avoid participation in any other interventional clinical trial for the duration of the study.
排除标准
- •Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including oral or parenteral corticosteroids.
- •Subject will not enroll with BP range higher than 180-120 or 100-
- •• Subjects that have participated in any other interventional clinical trial in the previous 90 days.
- •Subjects with known sensitivity to any of the constituents of the investigational product.
- •Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
- •Chronic illness which may influence the outcome of the study.
- •Pregnant/nursing mothers.
结局指标
主要结局
1. Change in the Systolic and Diastolic Blood pressure
时间窗: Time Frame- 0 min and 30 min, 1hr, 2hr, 3hr, 4hr, 5hr, 6hr
2. Change in Heart rate
时间窗: Time Frame- 0 min and 30 min, 1hr, 2hr, 3hr, 4hr, 5hr, 6hr
3. Change in SGA
时间窗: Time Frame- 0 min and 30 min, 1hr, 2hr, 3hr, 4hr, 5hr, 6hr
次要结局
- Not Applicable(Not Applicable)
研究者
Dr Mansoor Riyaz
CCFT Laboratories