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Clinical Trials/CTRI/2025/03/081817
CTRI/2025/03/081817
Not yet recruiting
Phase 2/3

RANDOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF GOKSHURADI KWATH AND KAKUBHADI CHURNA IN THE MANAGEMENT OF AAVRIT VYAAN W.S.R. TO ESSENTIAL HYPERTENSION

Ayurvedic and Unani Tibbia College and Hospital1 site in 1 country60 target enrollmentStarted: April 1, 2025Last updated:
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Overview

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Ayurvedic and Unani Tibbia College and Hospital
Enrollment
60
Locations
1
Primary Endpoint
change in Systolic & Diastolic Blood pressure.
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

•Hypertension

  • or elevated blood pressure - is a serious medical condition that significantly increases the risk of heart attack, stroke, kidney failure and blindness. It is also called silent or hidden killer because most of the sufferers (85%) are asymptomatic and as per available  survey reports, in more than 95% cases of hypertension underlying cause is not known.

•Prevalence of hypertension is increasing in many countries as well as in India, Incidence of Hypertension has gone up from 5% in the 1960s to nearly 12% in 1990s, and more than 30% in 2008.

•It is one of the leading causes of premature death worldwide killing nearly 9.4 million people every year globally.

•There is no direct reference of Hypertension in Ayurvedic classics by nomenclature. So on the basis of Sign & Symptoms it can be corelated to Aavaran of Vyaan Vaat.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
20.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Subjects willing to participate and able to provide written informed consent.
  • •Patient diagnosed as Stage- 1 Essential hypertension would be selected for study on the basis of 8th JNC & WHO criteria.

Exclusion Criteria

  • •Patient diagnosed as secondary hypertension or pre-hypertension or taking any Antihypertensive drug.
  • •Subjects with any previous Cardiovascular disease or known cases of MI,unstable angina or CHF.
  • •Subject suffering from any hepatic disorder (SGPT and SGOT more than two times the upper limit of normal) or Renal dysfunction, uncontrolled Pulmonary dysfunction (asthmatic and COPD subjects).Subjects with current or past diagnosis of malignancy (any malignancy diagnosis in last five years).Subjects who have a recent history or who are currently known to abuse of alcohol or drugs.Subjects suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, TB, AIDS etc).Pregnant / Lactating women.Subject on systemic or oral steroids, oral contraceptive pills or estrogen replacement therapy.Subjects who have completed participation in any other clinical trial during the past six (06) months.

Outcomes

Primary Outcomes

change in Systolic & Diastolic Blood pressure.

Time Frame: Baseline & Day 91

Secondary Outcomes

  • change in assessed symptoms of Essential hypertension.(Day 1,91)

Investigators

Sponsor
Ayurvedic and Unani Tibbia College and Hospital
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Aman Raj

Ayurvedic and Unani Tibbia College and Hospital

Study Sites (1)

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