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Clinical Trials/CTRI/2012/05/002663
CTRI/2012/05/002663RecruitingPhase 2

Clinical Evaluation of Ashwagandhadyarishta, Jatamamsi Arka and Sarpagandha Vati in the Management of EssentialHypertension (Uccha Raktachapa) - ACT- HTN-2010

Department of AYUSH Ministry of Health Family Welfare Government of India0 sites150 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 2
Status
Recruiting
Sponsor
Enrollment
150
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • •1. Patients of either sex aged 18 years and above.
  • •2. Diagnosed patients of essential hypertension with:
  • •S.B.P. < 159 mm. Hg. and >= 140 mm Hg.
  • •D.B.P. <= 99 mm. Hg. and > 90 mm. Hg
  • •(Hypertension Stage â??1, as per JNC VII report, 2004)
  • •3. Willing and able to participate for 16 weeks

Exclusion Criteria

  • •1. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
  • •2. Symptomatic patients with clinical evidence of Heart failure.
  • •3. Secondary hypertension.
  • •4. Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2mg/dl),uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.
  • •5. Patients with Diabetes Mellitus {B.S. (F) > 126 mg% and / or B.S. (2 hr. PP)
  • •>200 mg% OR HbA1c > 6.5%}
  • •6. Women who are pregnant or lactating.
  • •7. Patients on steroids, oral contraceptive pills or estrogen replacement therapy.
  • •8. Alcoholics and/or drug abusers.
  • •9. Serum Triglycerides >= 250 mg/dl
  • •10. Patients with evidence of malignancy
  • •11. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)
  • •12. H/o hypersensitivity to any of the trial drugs or their ingredients.
  • •13. Patients who have completed participation in any other clinical trial during the past six (06) months.
  • •14. Any other condition which the P.I. thinks may jeopardize the study.

Investigators

Sponsor
Department of AYUSH Ministry of Health Family Welfare Government of India

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