A study on Siddha Drug (Thetran Vidhai Kudineer) for Type -2 Diabetes Mellitus

Phase 2

Completed

• Conditions: Health Condition 1: null- Type 2 Diabetes MellitusHealth Condition 2: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2017/02/007797
• Lead Sponsor: DrPElankani

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-08-26
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1.Age between 30 years to 60 years

2.Known or newly diagnosed( < 1year) cases of type 2 diabetes

Fasting plasma glucose- (126 mg/dl[7mmol/L] or higher

plasma glucose 2 hrs after-(>=200mg/dl[11.1mmol/l])

Glycated haemoglobin( A1C >= 6.5% and < 10%)

3.Patients who are not taking any other Anti-diabetic drugs.

Exclusion Criteria

1.Age below 30 years to 60 years

2.Glycated hemoglobin above 10.0%

3.Patients with CVS/Hepatic failure/Renal failure

4.Lactating mother

5.Pregnant or planning to become pregnant within the next 6 months.

6.Taking oral anti-diabetic therapies

7.Patients who are on long term use of steroids.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measures are Blood sugar and glycosylated <br/ ><br>hemoglobin (HbA1c). <br/ ><br>Timepoint: Baseline, 90 days <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Explanatory outcome measures include blood pressure, lipid profile,Body weight, waist circumference. <br/ ><br>Timepoint: Baseline, 90 days;Secondary outcome measures are self rated quality of life and diabetes symptoms. <br/ ><br>Timepoint: Baseline,90 days