Effect of Ayurvedic drug formulation on blood pressure.

A randomized, double-blind, clinical study to assess safety and efficacy of polyherbal formulation in mild to moderate hypertension - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084330

Enrollment

Registered

2025-04-07

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Stage 1 Essential hypertension (average automated systolic blood pressure of 140 to 160 mmHg or diastolic blood pressure of 90 to 100 mm of Hg acc. to JNC VIII) 2. 18 to 65-years-old Male or female and able to provide informed consent.

Exclusion criteria

Exclusion criteria: 1. Atrial Fibrillation (AF)/ Sick Sinus Syndrome (SSS)/ atrioventricular block 2-3 grade without pacemaker. 2. Bradyarrhythmia 3. Unstable Angina Pectoris (UAP)/AMI/ HF (NYHA class III - IV) 4. Uncontrolled diabetes mellitus (DM) 5. Gastro-intestinal ulcer 6. Liver dysfunction/ renal impairment 7. Treated with CCB (Calcium antagonists) or another beta blocker. 8. Pregnant or lactating women 9. Legal incapacity or limited legal capacity

Design outcomes

Primary

Measure	Time frame
Assessment of changes in systolic and diastolic blood pressure Timepoint: Baseline to 12 weeks	—

Secondary

Measure	Time frame
Change in eGFR (estimated glomerular filtration rate).Timepoint: baseline to 12 weeks. ;Assessment of change in anthropometric parameters like BMI, BMR, Waist and hip circumference.Timepoint: baseline to 12 weeks.;Assessment of change in improvement in quality of life health survey score Timepoint: baseline to 12 weeks. ;The safety of the intervention will be assessed by evaluating: Laboratory parameters of renal function test.Timepoint: baseline to 12 weeks. ;Adverse events profile from baseline to end of the study. Timepoint: baseline to 12 weeks. ;Compliance and tolerability of the investigational product throughout the study Timepoint: baseline to 12 weeks	—

Measure

Time frame

Change in eGFR (estimated glomerular filtration rate).Timepoint: baseline to 12 weeks. ;Assessment of change in anthropometric parameters like BMI, BMR, Waist and hip circumference.Timepoint: baseline to 12 weeks.;Assessment of change in improvement in quality of life health survey score Timepoint: baseline to 12 weeks. ;The safety of the intervention will be assessed by evaluating: Laboratory parameters of renal function test.Timepoint: baseline to 12 weeks. ;Adverse events profile from baseline to end of the study. Timepoint: baseline to 12 weeks. ;Compliance and tolerability of the investigational product throughout the study Timepoint: baseline to 12 weeks

—

Countries

India

Contacts

Public ContactDr Sarvesh Kumar Singh

National Institute of Ayurveda Jaipur

kshiprarajoria@gmail.com9001454100

Outcome results