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

Phase 3

• Conditions: Health Condition 1: I10- Essential (primary) hypertension

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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.

12.Any other condition, which the P.I. thinks, may jeopardize the safety of the patients.

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.Timepoint: 12 months

Secondary Outcome Measures

Name	Time	Method
•Change in IL-6 ,Serum Pro- BNP <br/ ><br>•Effect on lipid profile <br/ ><br>•Change in the SF-36-Health Survey Score. <br/ ><br>•To assess the safety of the Sarpgandha Mishran through recording of any AE/ADR reported by study participants <br/ ><br>•Change in LFT and RFT parameters in the study participants from baseline to further follow ups <br/ ><br>•Change in the level of oxidative stress markers viz., superoxide dismutase <br/ ><br>(SOD), catalase (CAT) and glutathione peroxidase (GPX) <br/ ><br>Timepoint: 12 months