A clinical trial on SAARANAI CHOORANAM in the management of RATHTHA KOTHIPPU (SYSTEMIC HYPERTENSION)

Phase 2

Not yet recruiting

• Conditions: Essential (primary) hypertension,

• Registration Number: CTRI/2022/03/040776
• Lead Sponsor: Government siddha medical college and hospital

Brief Summary

The study is a prospective open labelled phase II non-randomized clinical trial to evaluate the therapeutic efficacy of SAARANAI CHOORANAM in the management of RATHTHA KOTHIPPU (SYSTEMIC HYPERTENSION). The trial drug will be administered orally at the dose of 20mg/Kg/BW/Twice a day20mg/Kg/BW/Twice a day for 45 days along with Ghee / Jaggery as adjuvant in 40 patients. The trial period of 12 months will be carried out in Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli, Tamilnadu. The primary outcome will be the evaluation of therapeutic efficacy of trial drug SAARANAI CHOORANAM. The secondary outcome will be the evaluation of Siddha diagnostic parameters, aseessment of safety profile of trial drug, assessment of pharmacological and biochemical parameters of trial drug. In case of any adverse events (AE) is noticed and it will be referred to pharmacovigilance department of SCRI. Further management of patients will be given in OPD facility.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-01-03
• Study Start: 2022-11-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1.Patient presenting with the conditions such as known systemic hypertension.
• Stage II (≥140/ ≥90 mm/hg), AHA, Hyperlipidemia, Diabetic mellitus.
• Type II, Choronic alcoholism, Smoking.

Exclusion Criteria

• 1.Age group below 34 years and above 71 years.
• 2.Patients presenting with the following conditions, such as Known malignant Hypertension, Ischaemic heart disease, Chronic kidney disease, Chronic liver disease, Pregnancy, Lactating mother.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The outcome will be aimed at reducing the systemic hypertension. If during or after treatment systolic blood pressure below or equal to 130mmHg and diastolic blood pressure below or equal to 90mmHg it will be considered as successful outcome.	45 days

Secondary Outcome Measures

Name	Time	Method
1.To evaluate the pharmacological activities of trial drug.	2.Study about the prevalance of Raththa kothippu (Systemic Hypertension) in relation between diet and life style.

Trial Locations

Locations (1)

Government Siddha Medical College and Hospital; 🇮🇳 Tirunelveli, TAMIL NADU, India

Government Siddha Medical College and Hospital

🇮🇳Tirunelveli, TAMIL NADU, India

Sivatheepan Sivalathajini

Principal investigator

9659690865

sivalatha088@gmail.com