Clinical study to evaluate the efficacy and safety of a unani drug in the management of hypertension.
- Conditions
- Health Condition 1: I10- Essential (primary) hypertension
- Registration Number
- CTRI/2023/03/050259
- Lead Sponsor
- ational Research Institute of Unani Medicine for Skin Disorders.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Participants of any sex aged 35-65 years
2. Stage-I Hypertension according to JNC 7
(Systolic BP 140-159 & Diastolic BP 90-99
mmHg)
3. Participants willing to sign the informed consent
form and to comply with the protocol
1. Participants aged <35 and >65 years
2. Participants with SBP >=160 mmHg and DBP >=100 mmHg
3. Participants with Secondary Hypertension and
Type 2 DM
4. Known cases of significant Pulmonary/Cardiovascular/ Hepato-renal Dysfunction, Malignancy, HIV infection, AIDS, etc.
5. Pregnancy and Lactation
6. Known allergy, sensitivity or intolerance to the study drug or any of its ingredients
7. Any other clinical condition that in the opinion of the investigator would compromise the
patientâ??s safety or successful participation in the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in SBP â?¥ 20 mmHg and diastolic blood pressure â?¥ 10 mmHg from baseline.Timepoint: 4 Weeks
- Secondary Outcome Measures
Name Time Method Systemic safety assessmentTimepoint: 4 Weeks