Clinical trial of Diabetone tablet along with Cinafen plus tablet in subjects with Diabetes Mellitus.

Phase 4

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

Registration Number: CTRI/2022/09/045739

Lead Sponsor: Meyer Organics Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Adults (age 30 to 70) both sex with BMI more than or equal to 19.00 kg/m2.

2.Patients with Metformin as an oral hypoglycemic agents as on-going or planned treatment for Type 2 Diabetes Mellitus since not more than 2 years from date of screening. Subjects willing to replace Metformin with investigational products if to be randomized in treatment group (Group A) in the study.

3.Hemoglobin A1c (HbA1c) more than 5.7 % and less than 7.5%.

4.Fasting Plasma Glucose (FPG) more than or equal to 90 mg/dL and less than or equal to 250 mg/dL.

5.Subjects with symptoms as mentioned in study protocol (At least one) prevalent at the time of screening for the study.

Exclusion Criteria

1.Subjects with Type 1 diabetes.

2.Subjects under Insulin treatment.

3.Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT >1.5 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine >1.4 mg/dl) as per discretion of investigator.

4.Known case of uncontrolled pulmonary dysfunction or other active pulmonary infections as per discretion of investigator.

5.Pregnant or lactating women.

6.Smokers/Alcoholics and/or drug abusers.

7.Patients with known history or ongoing malignancy.

8.Patients suffering from major systemic illness necessitating medical care.

9.Any other reason which can affect the participation of the subject in the study as per investigatorÃ¢â?¬•s discretion.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Symptom scores related to diabetes like fatigue, polyuria, polydipsia, polyphagia, muscle cramps, numbness in the extremities, pedal oedema, from baseline to end of the study on 4-point ordinal scale from screening to end of the study- <br/ ><br>0-None <br/ ><br>1-Mild symptoms- not interfering with daily activities <br/ ><br>2-Moderate symptoms- interfering with daily activities <br/ ><br>3-Severe symptoms- interfering with daily activities severely <br/ ><br>2.Fasting and post meal plasma glucose levels from screening to end of the study. <br/ ><br>3.Levels of HbA1c at screening and end of the study.Timepoint: Screening, Day 30, Day 60 and Day 90

Secondary Outcome Measures

Name	Time	Method
1.HOMA-IR score (Calculated Insulin Resistance based on formula with fasting plasma glucose and fasting serum insulin levels) at screening and end of the study. <br/ ><br>2.Anthropometric parameters like body weight and BMI at screening and end of the study. <br/ ><br>3.Changes in vital parameters like blood pressure, heart rate etc from screening to end of the study. <br/ ><br>Timepoint: Screening, Day 30, Day 60 and Day 90