A clinical study on effects of Sugaheal® in patients with Type 2 Diabetes Mellitus

Not Applicable

• Conditions: Health Condition 1: null- Type 2 Diabetes MellitusHealth Condition 2: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2013/01/003314
• Lead Sponsor: Indus Biotech Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Treatment naïve patients of type 2 diabetes mellitus (defined as never receiving medical treatment for diabetes [insulin and/or oral antihyperglycemic medication] for > 6 months since original diagnosis, and no oral antihyperglycemic medication for more than 3 consecutive days or 7 nonconsecutive days during the 8 weeks prior to screening)

2.Fasting Plasma glucose (FPG) between 126 mg/dl and 250 mg/dl

3.Male or Female between 30 years to 65 years of age

4.Body Mass Index (BMI) between 18 kg/m2 to 30 kg/m2

5.HbA1c between 7% to 10% both inclusive

6.If on anti-hypertensive, lipid-lowering, or thyroid medications or hormone therapy, has been on constant dosage for at least 3 months prior to screening visit.

7.Patients those have voluntarily given written informed consent

8.Women with childbearing potential, willing to use effective contraceptive measures (other than oral contraceptive pills) such mechanical or barrier contraceptives, post- menopausal will be included.

9.In the opinion of the investigator, able to comply with the requirements of the protocol

10.Patients who received counseling on diet and exercise consistent with ADA recommendations

Exclusion Criteria

•Patients on hyperglycemic agent at screening visit

•Type 1 diabetes patients

•Females who are pregnant, lactating or planning to become pregnant

•Known allergy to study medication

•Patients with underline chronic disease of heart, liver, kidney, endocrine or neurological disease.

•History of diabetic ketoacidosis or hyperosmolar nonketotic coma

•Has a contagious, infectious disease

•Currently taking herbals, dietary supplements, or medications, during the past 12 weeks that could profoundly affect blood glucose

•Active malignancy.

•AST / ALT more than or equal to 2.5 times the upper limit of normal laboratory value ( i.e. AST more than or equal to 100 and ALT more than or equal to 25 )

•Serum creatinine more than or equal to1.5 mg/dl,

•Any other conditions not eligible for the trial as per investigator or clinically significant abnormal laboratory values at screening visit.

•Clinically significant abnormal red cell turnover, such as recent blood loss or transfusion or anemia [hemoglobin levels: less than 10 mg% (Male) and less than 9 mg% (Female)]

•Patient of heart disease of Class III (marked limitation of any activity, the patient is comfortable only at rest) and Class IV (any physical activity brings discomfort and symptom occur at rest) as per New York Heart Association functional classification of heart diseases

•Patients who smokes10 cigarettes per day

•Alcohol intake more than 2 drinks/day

•Subject participating simultaneously or 3 months prior to screening in any other clinical trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycated hemoglobin (HbA1c) values (%)Timepoint: Screening, Week-12, Week-24