CTRI/2020/04/024719
Completed
Phase 3
Comparative clinical study to evaluate the efficacy of Shigru Kwatha and Gokshura Churna in the management of Essential Hypertension- Randomized Control Study
Ayurvedic and Unani Tibbia College and Hospital0 sites60 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: I10- Essential (primary) hypertension
- Sponsor
- Ayurvedic and Unani Tibbia College and Hospital
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subjects willing to participate and able to provide written informed consent.
- •2\. Subjects belonging to either gender between the age group 20 to 60 years.
- •3\. Patient diagnosed as Stage\- 1 E.H.T. would be selected for study on the basis of 7th JNC \& WHO criteria.
- •4\. Subjects who are able to come for follow up on fixed visits and are well aware about the treatment plan.
Exclusion Criteria
- •1\. Already diagnosed cases of Cardiovascular disease/ Cerebrovascular disease / Renal disease/ Hypertensive Retinopathy.
- •2\. Subjects with any unstable Heart disease or known cases of MI, unstable angina or CHF.
- •3\. Patients with concurrent Hepatic Dysfunction (defined as AST and/or ALT \> 2 times of the upper normal limit) or Renal Dysfunction, uncontrolled Pulmonary Dysfunction (asthmatic and COPD subjects).
- •4\. Subjects with current or past diagnosis of malignancy (any malignancy diagnosis in last five years).
- •5\. Subjects who have a recent history or who are currently known to abuse of alcohol or drugs.
- •6\. Subjects suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho\-Neuro\-Endocrinal disorders, TB, AIDS etc).
- •7\. Female subject of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy.
- •8\. Pregnant / Lactating women.
- •9\. Subject on systemic or oral steroids, oral contraceptive pills or estrogen replacement therapy.
- •10\. Subjects having hypersensitivity to any of the trial drug.
Outcomes
Primary Outcomes
Not specified
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