Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Diabelyn Capsules: Diabelyn�® is in the form of 250 Capsule,this will be administed 2 time a day for the period of 90 days as randomised. Diabelyn is a combination of the following he
Sponsors
Herbalyn Lifesciences Inc
Invitro Research Solutions Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: a. Male or female patients of 25 to 60 years, both inclusive b. Have newly diagnosed treatment na�¯ve type II diabetes for greater than or equal to 3 months based on the disease diagnostic criteria. c. Subjects are treatment-na�¯ve, not optimally controlled with diet and exercise alone, not received treatment with any anti-hyperglycemic medications. d. Fasting Plasma Glucose more than or equal to 120 mg/dL to less than or equal to 150 mg/dl in the subject. e. Have a body mass index (BMI) less than or equal to 35.00 kg/m2. f. Subject who will follow all study related procedures and willing to take rescue medication for use as per requirement for the duration of the study.
Exclusion criteria
Exclusion criteria: a. Pregnant or lactating or planning to become pregnant and women with reproductive potential unwilling to follow standard contraception methods. b. Subjects having type 1 diabetes mellitus, gestational diabetes, secondary diabetes. c. Any history suggestive of microvascular or macrovascular disease d. Impaired renal function; eGFR less than 60 ml/min/1.73 m2 e. Known history of any chronic illness taking regular pharmacological agents f. Subjects diagnosed with uncontrolled hypertension. g. Subjects who have participated in a medical, surgical, or pharmaceutical study where these types of procedures were performed within 60 days prior to screening. h. History of asthma, hypertension, thrombotic events, stroke, congestive heart failure, impaired cognitive function, and impaired hepatic function. i. Known hypersensitivity to any of the study products. j. History of use of any nutraceutical products in the last four weeks prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint includes: Change from baseline to end of the study treatment period (Day 0 and Day 90) in ââ?¬Â¢ Fasting Blood Sugar ââ?¬Â¢ Glycosylated Hemoglobin (HbA1c) {In PP and comparison between the four treatment arms of A, B, C and D}Timepoint: day 0 to day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ Change from Baseline to end of study treatment in (OGTT), Serum Insulin level and C-Peptide. ââ?¬Â¢ Diabetes Treatment Satisfaction Questionnaire Score (Day 0, Day 30, Day 60 and Day 90) ââ?¬Â¢ Diabetes Symptoms Checklist Participant-reported Outcome, Score (Day 0, Day 30, Day 60 and Day 90) ââ?¬Â¢ Change from Baseline to End of Study in (BMI) (Day 0 and Day 90)Timepoint: day 0 to day 90 | — |
Countries
India
Contacts
Public ContactMr T Vijay Bhaskar
iVRS Pvt Ltd
Outcome results
None listed