Ayurveda Intervention in Left Ventricular hypertrophy

Randomized controlled trial of Anshumati Ksheer Paka in hypertension induced left ventricular hypertrophy. - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064352

Enrollment

110

Registered

2024-03-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: I422- Other hypertrophic cardiomyopathy Health Condition 2: I517- Cardiomegaly

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 2. Participants diagnosed with LVH having left ventricular mass index more than 115 g/m2 in men, and more than 95 g/m2 in women, as evidenced by echocardiography. 3. Participants having mild to moderate Hypertension (grade 1 and 2) 4. Participant willing and able to give informed consent.

Exclusion criteria

Exclusion criteria: 1. Left Ventricular Ejection Fraction less than 45% on screening echocardiography. 2. History of myocardial infarction or stroke within 6 months 3. History of Heart failure, ischemic heart disease, valvular heart disease, arrhythmias, peripheral vascular disease, history of any type of cardiac surgery. 4. Renal dysfunction, chronic kidney disease (GFR less than 60 ml/min), Significant chronic renal impairment (Serum creatinine more than 2.0 mg/dL). 5. Severe hypertension (Systolic BP more than or equal to 180 mm Hg or Diastolic BP more than or equal to 110 mm Hg). 6. Diabetic patients with HbA1c more than 7%. 7. Diagnosed Patients of Dyslipidemia having values of total Cholesterol (more than 240 mg/dl), Low Density Lipoprotein (LDL more than 160 mg/dl), Triglycerides (more than 200 mg/dl) and High Density Lipoprotein (HDL less than 40 mg/dl) 8. Known cases of lactose intolerance. 9. Participants who have participated in any other clinical trial within the previous 30 days. 10. Pregnant/lactating females 11. Participants with a history of substance abuse or alcohol abuse and smokers 12. Any other condition which the P.I. thinks may jeopardize the study.

Design outcomes

Primary

Measure	Time frame
Changes in Left Ventricular Mass Index from baselineTimepoint: Baseline, 3 months, 6 months	—

Secondary

Measure	Time frame
1. Number of participants with reduction of left ventricular hypertrophy 2. Changes in Left Ventricular Ejection Fraction 3. Changes in Left Ventricular end systolic/Diastolic volume 4. Changes in Inflammatory (CRP, IL-6) & cardiovascular blood markers (NT-proBNP, Troponin T)150 5. Number of participants with Adverse Event 6. Safety profile (CBC, LFT, KFT, e-GFR) assessment Timepoint: Baseline, 3 months, 6 months	—

Measure

Time frame

1. Number of participants with reduction of left ventricular hypertrophy 2. Changes in Left Ventricular Ejection Fraction 3. Changes in Left Ventricular end systolic/Diastolic volume 4. Changes in Inflammatory (CRP, IL-6) & cardiovascular blood markers (NT-proBNP, Troponin T)150 5. Number of participants with Adverse Event 6. Safety profile (CBC, LFT, KFT, e-GFR) assessment Timepoint: Baseline, 3 months, 6 months

—

Countries

India

Contacts

Public ContactDr Neha Dubey

VMMC and Safdarjung Hospital , New Delhi

pg.ucms@gmail.com01126766401

Outcome results