To study the effect of diafyn in mild diabetes patients.

Completed

• Conditions: Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH,

• Registration Number: CTRI/2023/02/050111
• Lead Sponsor: Sri Sri Institute for advanced research (SSIAR)

Brief Summary

Type 2 Diabetes Mellitus is a metabolic disorder of chronic origin having elevated levels of blood glucose which leads to serious damage of various vital organs specially kidney, eye and nerves. This study was done to evaluate the efficacy and safety of Tablet Diafyn in patients suffering with Type 2 Diabetes Mellitus in achieving the glycemic control. It will be a Randomized Controlled Trial with 2 groups (Interventional arm and control arm), Randomization will be done through computer; allocation concealment and double blinding (investigator and patient) will be followed in the study. Drug compliance will be monitored through home visits by Medical Social Workers. Intervention group will be receiving Tab Diafyn 1gm thrice a day before food and control arm will be receiving Placebo 100% Starch 1 gm thrice a day before food. Starch can increase the blood sugar level, although slowly. Control arm patients also receive standard treatment for diabetes. Following investigations will be done on Day 0 and Day 90:- HbA1c, Fasting and Post Prandial blood sugar, Lipid Profile, B.Urea, S.Creatinine, AST and ALT.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-28
• Last Update Posted: 2023-12-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Newly diagnosed and those subjects on treatment of Type 2 Diabetes Mellitus 2) Age group between 25 to 55 years 3) Glycosylated hemoglobin (HbA1c) between 6.4% to 8.

Exclusion Criteria

• 1. Subjects with Type 1 Diabetes Mellitus 2) Subjects with established cases of Alcoholism and Drug abuse 3) Pregnant and lactating women.
• 4. Subjects with major renal and hepatic disorder.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Values of FBS PPBS LFT HbA1C will be assessed at the end of the study	Baseline and end of 13 weeks.

Secondary Outcome Measures

Name	Time	Method
The safety of the drug will be assessed throughout the study.	Day0,Day90.

Trial Locations

Locations (1)

Atharva multi speciality hospital and research centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

Atharva multi speciality hospital and research centre

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Abhishek Jaiswal

Principal investigator

9889441902

drabhishekarun@gmail.com