Clinical trial of Siddha Drug "Naga Chendhooram" for Diabetes

Phase 2

Not yet recruiting

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2019/08/020946
• Lead Sponsor: Government Siddha Medical College

Brief Summary

This is a Non randomised open clinical trial to study the safety and efficacy of siddha drug "Naga Chendhooram". Drug is given 100 mg twice a day for 90 days. Clinical trial is conducted after completion of preclinical toxicity studies. The said drug "Naga Chendhooram" has reference in "Siddha Formulary of india" - part1 . During the study, all the related data will be recorded and documented.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-09
• Last Update Posted: 2019-08-27

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Mandatory Fasting blood glucose-120 to 160 mg/do PP blood glucose- 180 to 280 mg/DL HbA1c- 6.5 to 9% Optional Polyuria Polyphagia Polydipsia Nocturia.

Exclusion Criteria

Insulin dependent Diabetes mellitus Cardiovascular disease Diabetic nephropathy Diabetic retinopathy Pregnant women Lactating mothers Tuberculosis affected individuals HbA1c > 9%.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in clinical symptoms	90 days
Reduction in blood sugar and HbA1c level by atleast 20% or to maintain HbA1c level within 7%	90 days

Secondary Outcome Measures

Name	Time	Method
Secondary outcome is assessed by comparing the safety parameters before and after treatment	90 days

Trial Locations

Locations (1)

Arignar Anna Government Hospital of Indian Medicine; 🇮🇳 Chennai, TAMIL NADU, India

Arignar Anna Government Hospital of Indian Medicine

🇮🇳Chennai, TAMIL NADU, India

Dr Jani Antony S

Principal investigator

9994880753

janiantony27@gmail.com