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Clinical Trials/CTRI/2020/04/024719
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

Sponsor
Ayurvedic and Unani Tibbia College and Hospital

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