clinical study of Diabetic Support Product in Subjects suffering from Type II Diabetes

Phase 3

Completed

• Conditions: Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications

• Registration Number: CTRI/2022/01/039179
• Lead Sponsor: Mr Kamlesh Thummar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-04-15
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 156

Inclusion Criteria

Patients between 30-70 (both inclusive) age both sex

Patients receiving standard treatment for Type 2 Diabetes Mellitus

Hemoglobin A1c (HbA1c) >6.5 % and <10% (both inclusive)

Fasting Plasma Glucose (FPG) >130 mg/dL and < 250 mg/dL (both inclusive)

Exclusion Criteria

Type 1 diabetes under Insulin treatment

Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT >3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine >1.4 mg/dl), uncontrolled

Pulmonary Dysfunction (asthmatic and COPD patients) or another concurrent severe disease.

Women who are pregnant or lactating

Smokers/Alcoholics and/or drug abusers

Patients with evidence of malignancy

Patients suffering from major systemic illness necessitating long-term drug treatment (Rheumatoid arthritis, Psycho-Neuro- Endocrinal disorders, etc.)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Fasting and postprandial Blood Glucose. <br/ ><br>Change in Fasting and post meal insulin levels. <br/ ><br>Change in HbA1c levels.Timepoint: Screening Day, Baseline Day, Day 30 , Day 60 , Day 90

Secondary Outcome Measures

Name	Time	Method
To evaluate changes of the b-cell functions (homeostasis <br/ ><br>model assessment [HOMA]-b, insulin resistance (IR) by HOMA- <br/ ><br>IR <br/ ><br>To evaluate changes in anthropometric parameter like Body weight and BMI <br/ ><br>Improvement in the clinical symptoms, i.e., Polyurea, <br/ ><br>Polyphagia, Polydypsia and Fatigue associated with type 2 DM. <br/ ><br>Changes in Quality of Life scoreTimepoint: Screening to end of the study