Management of Hypertension through Ayurveda

Phase 2/3

Not yet recruiting

Conditions: Essential (primary) hypertension. Ayurveda Condition: AVRUTA-VATAH/AVARANAVATA,

Brief Summary: **Introduction**

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 killer because most of the suffers (85%) are asymptomatic and as per available reports, in more than 95% cases of hypertension underlying cause is unknown. such patients have essential hypertension. WHO had published "A Global Brief on Hypertension- silent killer, a public health crisis" on World health day 2013.

**Research Question**

Whether Shuddh Shilajit and Maansyadi Kashaya effective in the management of essential hypertension?

**Material and Methods**

The study design is as follows:

Study type - Interventional

Subtype - Comparative Clinical trial

Purpose - Treatment

timing - prospective

Masking - Open clinical

Sampling method - Simple random

End point - Efficacy and Safety

Sample size - 60 patients

No. of Groups - 3

Selection of patients - OPD/IPD of Ayurvedic and Unani Tibbia College and Hospital

Sample population - Subjects from Ayurvedic and Unani Tibbia College and Hospital

Duration of Trial - 3 months

Recruitment & Eligibility

Inclusion Criteria

Subject willing to participate and able to provide written informed consent.
Patient diagnosed as stage-I Essential Hypertension would be selected for study on the basis of 8th JNC & WHO criteria.
Subjects who are able to come for follow up on fixed visits.

Exclusion Criteria

Already diagnosed cases of Cardiovascular disease/ Cerebrovascular disease/ Renal disease/ Hypertensive Retinopathy.
Subjects with any unstable heart disease or known cases of MI, unstable angina or CHF.
Patients with concurrent hepatic dysfunction (defined as AST and/or ALT >2times of the upper normal limit) or Renal dysfunction, uncontrolled pulmonary dysfunction (asthmatic and COPD subjects).
Subjects with current or past malignancy.
Subject of have recent history or who are currently known to abuse of alcohol or drugs.
Subjects suffering from major systemic illness neccessitating long term drug treatment(rheumatoid arthritis, psyco-neuro-endocrinal disorders, Tb, AIDS).
Pregnant/lactating women.
Subject on systemic or local steroids, oral contraceptive pills or estrogen replacement therapy.
Subjects having hypersensitivity to any of the trial drug.
Subjects who have completed participation in any other clinical trial during the past six (06) months.

Primary Outcome Measures

Name	Time	Method
Improvement in Subjective symptoms	Follow up at 15 days interval

Secondary Outcome Measures

Name	Time	Method
Changes in Blood Pressure readings	Follow up at 15 days interval

Locations (1): Ayurvedic and Unani Tibbia College and Hospital
🇮🇳
Central, DELHI, India
Ayurvedic and Unani Tibbia College and Hospital
🇮🇳Central, DELHI, India
Dr Rishabh
Principal investigator
9990300944
rishabhkumar747@gmail.com