Seenthil Chooranam for Type II Diabetes Mellitus

Phase 2

Not yet recruiting

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2023/08/056858
• Lead Sponsor: J Rohini alias Elavarasi

Brief Summary

Diabetesmellitus is a clinical syndrome characterised by increase in plasma bloodglucose (Hyperglycemia). There are two types of diabetes mellitus ,Type I andType II. Type I Diabetes Mellitus is caused by autoimmune destruction of betacells in the pancreas, resulting in absolute insulin deficiency, whereas TypeI  Diabetes Mellitus is due to insulin deficiency or defective actionof insulin or both.Chronic hyperglycemia is responsible fordiabetes specific microvascular complications affecting the eyes (retinopathy),kidneys (nephropathy) and feet (neuropathy).

Indiais deemed as the world’s capital of Diabetes. In 2021, approximately 537million adults (20-79years of age ) are living with diabetes. The total numberof people living with diabetes is projected to rise to 643 million by 2030 and783 million by 2045.The diabetic population in the country close to hitting thealarming mark of 69.9 million by2030.

Theclassical siddha medicine formulation **“SEENTHIL CHOORANAMâ€**mentionedin **"The Siddha Formulary of India-Part I ".**isindicated for Madhumegam (Diabetes mellitus). Moreover this formulation hasanti-diabetic activity that had been proven scientifically .So the authortries to evaluate its efficacy in the management of Type II DiabetesMellitus)in a non-randomised open clinical trial.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-09
• Last Update Posted: 2023-08-23

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1 Sex: All Gender 2 Polyuria 3 Polyphagia 4 Polydipsia 5 Nocturia 6 HbA1C.

Exclusion Criteria

1 Pregnant women 2 Lactating mothers 3 Insulin dependent Diabetes mellitus 4 Cardiovascular disease 5 Diabetic nephropathy 6 Diabetic retinopathy • Recently diagnosed patient with tuberculosis • HbA1c > 9% The above criteria will be excluded clinically or based on the available medical reports.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in HbA1C level (at least 20%)	90 Days

Secondary Outcome Measures

Name	Time	Method
Reduction in clinical symptoms like Polyuria,Polydipsia,Polyphagia & Fatigue.	90 Days

Trial Locations

Locations (1)

Government Siddha Medical College; 🇮🇳 Chennai, TAMIL NADU, India

Government Siddha Medical College

🇮🇳Chennai, TAMIL NADU, India

Dr J Rohini alias Elavarasi

Principal investigator

9003988208

rohinielavarasi@gmail.com