Clinical study on Yesaka Plus Tablets in Type 2 Diabetic Patients

Phase 2

Completed

Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

Registration Number: CTRI/2022/04/042122

Lead Sponsor: Simandhar Herbal Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Patients diagnosed with type 2 diabetes mellitus for not more than one year and those are not on any oral hypoglycemic agent/insulin (regular basis).

2.Patients having HbA1C value between 6.5-8.5% (both inclusive) at screening.

3.Patients having Fasting Plasma Glucose between 126 -250 mg/dl (both inclusive) at screening.

4.Patients having postprandial glucose not more than 350 mg/dl at screening

5.Patient’s ECG does not demonstrate any signs of uncontrolled arrhythmia / acute ischemia.

6.A negative urine pregnancy test for all female patients unless patient has had a hysterectomy, tubal ligation, or is > 2 years post menopause.

7.Patients willing to follow the procedures as per the study protocol and voluntarily signing informed consent form

Exclusion Criteria

1.Patients already on regular OHAs or on insulin therapy.

2.Patients suffering from type-1 DM or types of Diabetes mellitus other than Type-2

3.Patients with known history of chronic hepatic or renal disease.

4.Patients with known history of malignancy.

5.Patients with known history of significant cardiovascular event 12 weeks prior to randomization.

6.Patients with known history of major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds.

7.Patients with known history of chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.

8.Patients with known history of active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.

9.History of Use of any other investigational drug within 1 month prior to randomization

10.Known history of hypersensitivity to ingredients used in study drug

11.Pregnant and Lactating females.

12.Any other conditions which in the opinion of investigator will place the Patients at risk or will influence the conduct of study or interpretation of results

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Change in HbA1C% (Glycosylated Hemoglobin) over a period of three months and between the groups <br/ ><br>2.Change in FBS and PPBS on monthly basis over 90 days (Before and after treatment) and between the groups <br/ ><br>Timepoint: Day -7, Day 0, Day 30, Day 60, Day 90

Secondary Outcome Measures

Name	Time	Method
1.Change in Fasting Serum Insulin. <br/ ><br>2.Change in HOMA-IR score <br/ ><br>3.Change in clinical symptoms of Type 2 DM <br/ ><br>4.Difference in the number of rescue medication required by each group <br/ ><br>5.Monthly change in weight and BMI. <br/ ><br>6.Change in quality of life assessed on QOLID. <br/ ><br>7.Change in global assessment for overall change by subject and investigator. <br/ ><br>8.Tolerability of study drugs <br/ ><br>9.Change in Laboratory parameters <br/ ><br>Timepoint: Day -7, Day 0, Day 30, Day 60, Day 90