AYUSH M3 for Pre-Hypertension

Evaluation of Efficacy and Safety of AYUSH- M3 in the management of Pre-Hypertension â?? A Double blind Randomized control clinical study

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/09/028121

Enrollment

420

Registered

2020-09-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I10- Essential (primary) hypertension

Interventions

Intervention1: AYUSH M3, Life style advocacy: Dose 500mg twice daily Dosage form Tablet Route of Administration Oral Time of Administration Twice a day after food Anupana Water Packing form 60 tablet

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either sex aged 30-65 years. Diagnosed patients of Pre hypertension as per 7th report of JNC (120-139 of Hg SBP or 80-89 mm of Hg DBP) Willing and able to participate for 3 months

Exclusion criteria

Exclusion criteria: Patients who have history of Cardiac Arrhythmia, Acute Coronary Syndrome, Myocardial Infarction, congestive cardiac failure ,Stroke or Severe Arrhythmia in the last 6 months. Essential Hypertension / Secondary hypertension. Patients with concurrent Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2 mg/dl),uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Neurological disorders, Endocrinal disorders, etc.) or Known cases of malignancy Uncontrolled Diabetes Mellitus(HbA1C >8) Women who are planning for conception / pregnant or lactating. H/o hypersensitivity to any of the trial drugs or their ingredients. Patient taking participation in any other clinical trial. Any other condition which the P.I. thinks may jeopardize the study.

Design outcomes

Primary

Measure	Time frame
Changes from baseline measurements of systolic blood pressure and diastolic blood pressure.Timepoint: baseline, 2nd, 4th, 6th, 8th, 10th,12th week.	—

Secondary

Measure	Time frame
Effect on lipid profile 2. Effect on HbA1c 3. Effect on Ejection Fraction 4. Change in the SF-36-Health Survey Score. 5. Safety parametersTimepoint: baseline, 2nd, 4th, 6th, 8th, 10th, 12th week	—

Countries

India

Contacts

Public ContactDr Sakshi Sharma

CARICD

drsakshi.sharma87@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026