Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: GLUBLOCâ?¢ tablet: Each tablet contains a proprietary blend of Morus alba L extract and Malus domestica peel extract (350 mg) along with the excipients.
The subjects will receive inter
Sponsors
INU Energy Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Age: 25 - 65 years old male and non-pregnant females Diagnosis of Type 2 Diabetes Mellitus for at least 6 months; treated with stable dose of oral anti-diabetic drugs (drugs permitted: metformin, sulfonylureas) for at least 3 months before screening. Participants with HbA1c between 7 to 11 percent Participant willing to provide informed consent and willing to comply with study procedures
Exclusion criteria
Exclusion criteria: Type 1 Diabetes Mellitus participants. Type 2 Diabetes Mellitus participants on insulin, Thiazolidinediones, GLP-1 agonists, DPP-IV inhibitors, AGIâ??s and/or SGLT2 inhibitors. Allergy to one or more components of the investigational product or history of food allergies Participant receiving any diabetes specific nutritional food supplement apart from multivitamin/ mineral supplements (Ca/Vit D supplements and B complex syrups) within 15 days prior to study start. Participant taking any herbal/ayurvedic/ alternative medicine preparations that could profoundly affect blood glucose. Females who are nursing / pregnant / are of child - bearing potential and not practicing an acceptable method of birth control / or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Participant has evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease, which in the opinion of the investigator, can adversely affect study outcome/s. Participant with active infection in past 30 days. Participant has a history of any episode(s) of severe hypoglycemia (requiring third party assistance), disabling diabetic neuropathy including autonomic neuropathy, gastroparesis or lower limb ulceration or amputation or evidence or history of diabetic complications with significant end organ damage. Participants on any pharmacological therapy of modern or alternative medicine for management of obesity in past 6 months. Participants with history of bariatric surgery. Participant has any major or minor surgery within 30 days prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A reduction in HbA1c levels, improvement in glycemic Variability and time in range (based on CGM measurements) with GLUBLOCâ?¢ treatment in Type 2 diabetic individuals.Timepoint: Day 0 (Baseline), day 60, day 90 and day 180. | — |
Secondary
| Measure | Time frame |
|---|---|
| A reduction in Weight, waist-hip ratio, BMI and subjective feeling of energyTimepoint: Baseline (day 0), day 60, day 90 and day 180. | — |
Countries
India
Contacts
Public ContactDR K. Somnath Gupta
Yashoda Hospitals
Outcome results
None listed