CTRI/2020/04/024719CompletedPhase 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 enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
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.
- •11. Subjects who have completed participation in any other clinical trial during the past six (06) months.
- •12. Pregnancy induced hypertension.
Investigators
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