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Clinical Trials/CTRI/2018/04/013523
CTRI/2018/04/013523RecruitingPhase 2

A prospective open labeled randomized clinical trial on VATHA PITHTHAM primary systemic hypertension with evaluation of trial drug SENKALUNEER CHOORANAM

Prof Dr S Neelavathi1 site in 1 country40 target enrollmentStarted: June 27, 2017Last updated:

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
To Evaluate the Therapeutic Efficacy of KALUNEER CHOORANAM in the Treatment of VATHA PITHTHAM

Study Overview

Brief Summary

The Study is Prospective Open Labeled Randomized Phase II Clinical Trial to Evaluate the Therapeutic Efficacy of Trail Drug SENKALUNEER CHOORANAM 800mg 1000mg tds for 30 days on the 40 Patients with VATHA PITHTHAM that will be conducted in Government Siddha Medical College and Hospital Palayamkottai The Primary Out come Therapeutic efficacy of SENKALUNEER CHOORANAM The Sencondary will be the Evaluation of Siddha Diagnostic Parameters

Study Design

Study Type
Observational

Eligibility Criteria

Ages
30.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patient with Symtoms Headache Giddiness Palpitation Dizziness Dyspnoea Shortness of Breath Fatigue Blood Pressure Systolic
  • 159 mmHg Diastolic 90.

Exclusion Criteria

  • Secondary Hypertension High Risk Pregnancy Hypertension Associated Cerebro Vascular Accident Ischemic Heart Disease Chronic Alcoholism Chronic Liver Disease Chronic Renal Disease Endocrine Disorder.

Outcomes

Primary Outcomes

To Evaluate the Therapeutic Efficacy of KALUNEER CHOORANAM in the Treatment of VATHA PITHTHAM

Time Frame: 30 Days

Secondary Outcomes

  • To Evaluate the Siddha Cofactor Towords the Efficacy of the Trial Drug SENKALUNEER CHOORANAM and to Evaluate the Pharmacological Action(30 Days)

Investigators

Sponsor
Prof Dr S Neelavathi
Sponsor Class
Government medical college

Study Sites (1)

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