Anti hypertensive activity of polyherbal formulation

Evaluation of the efficacy and safety of polyherbal formulation in mild to moderate hypertension : A randomized, double-blind, controlled clinical study - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079691

Enrollment

Registered

2025-01-29

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-03

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: 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)

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 other beta blocker. 8. Pregnant or lactating women 9. Legal incapacity or limited legal capacity

Design outcomes

Primary

Measure	Time frame
Percentage of patients achieving blood pressure (B.P) less than 140/ 90 mm of HgTimepoint: Baseline and at 12 weeks	—

Secondary

Measure	Time frame
Changes in Systolic blood pressure, diastolic blood pressure, mean arterial pressureTimepoint: baseline to 12 weeks;Safety will be assessed by recording adverse events (through 24 hours post-dose and at all follow-ups) and physical examination and vitals (Baseline to 12 weeks) along with the evaluation of LFT, and KFT.Timepoint: baseline to 12 weeks;Assessment of change in the proportion of subjects with reduced doses of conventional treatment from screening to end of the studyTimepoint: baseline to 12 weeks;Change in eGFR (estimated glomerular filtration rate)Timepoint: baseline to 12 weeks;Changes in Blood sugar levels, Lipid profile, BMI, Waist circumference of the patients and the Psychological and somatic wellbeing on the basis of Hamilton anxiety rating scale.Timepoint: baseline to 12 weeks	—

Measure

Time frame

Changes in Systolic blood pressure, diastolic blood pressure, mean arterial pressureTimepoint: baseline to 12 weeks;Safety will be assessed by recording adverse events (through 24 hours post-dose and at all follow-ups) and physical examination and vitals (Baseline to 12 weeks) along with the evaluation of LFT, and KFT.Timepoint: baseline to 12 weeks;Assessment of change in the proportion of subjects with reduced doses of conventional treatment from screening to end of the studyTimepoint: baseline to 12 weeks;Change in eGFR (estimated glomerular filtration rate)Timepoint: baseline to 12 weeks;Changes in Blood sugar levels, Lipid profile, BMI, Waist circumference of the patients and the Psychological and somatic wellbeing on the basis of Hamilton anxiety rating scale.Timepoint: baseline to 12 weeks

—

Countries

India

Contacts

Public ContactDr Sarvesh Kumar Singh

National Institute of Ayurveda Jaipur

kshiprarajoria@gmail.com09001454100

Outcome results