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Clinical Trials/CTRI/2020/04/024719
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.

Registry
who.int
Start Date
TBD
End Date
June 30, 2021
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Ayurvedic and Unani Tibbia College and Hospital

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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