Clinical study on Ayurvedic intervention (Sarpgandha Mishran) vs Amlodipine for the management of stage-I Primary Hypertension

Phase 3

Completed

• Conditions: Essential (primary) hypertension. Ayurveda Condition: RAKTAVRUTAVATAH,

• Registration Number: CTRI/2021/12/038589
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences

Brief Summary

This is a research study being conducted by Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of AYUSH, Government of India, involving administration of Sarpgandha Mishran) with a view scientifically document the clinical efficacy and safety of the said Ayurvedic formulation that have been in use since long period for the management of the Essential Hypertension (Uccha Raktachapa).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-16
• Last Update Posted: 2023-09-15

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1.Patients of either sex aged 30-65 years 2.Diagnosed patients of stage-I essential hypertension as per 8th report of JNC (140-159 mm of Hg SBP and 90-99 mm of Hg DBP) 3.Willing and able to participate for 3 months.

Exclusion Criteria

• 1.Patients who have history of Myocardial Infarction, congestive cardiac failure, Stroke or Arrhythmia in the last 6 months.
• 2.Secondary hypertension.
• 3.Patients with concurrent Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S.
• creatinine > 1.4 mg/dl),uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Neurological disorders, endocrine disorders, etc.) or known cases of malignancy.
• 4.Known cases of uncontrolled Diabetes Mellitus.
• 5.Women who are planning for conception / pregnant or lactating.
• 6.Patients suffering from Psychosis/depressive illness.
• 7.H/o hypersensitivity to any of the trial drugs or their ingredients.
• 8.Patient taking participation in any other clinical trial.
• 9.Participants who were tested COVID-19 positive (through a positive RT-PCR) in the last 30days.
• 10.Participants with Post COVID-19 complications or BP fluctuations following disease.
• 11.Participants who are still on COVID-19 related medical interventions.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes from baseline measurements of systolic blood pressure and diastolic blood pressure.	12 months

Secondary Outcome Measures

Name	Time	Method
•Change in IL-6 ,Serum Pro- BNP	•Effect on lipid profile

Trial Locations

Locations (1)

Department of Cardiology,; 🇮🇳 South, DELHI, India

Department of Cardiology,

🇮🇳South, DELHI, India

Dr Rajiv Narang

Principal investigator

01126593322

r_narang@yahoo.com