Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine
Conditions
Interventions
This will be a three-arm, open-label, non-inferiority randomized controlled trial in patients with type 2 diabetes mellitus (T2DM). Participants will be recruited using a consecutive consenting sampli
Arm II will receive freeze-dried GS powder equivalent to the decoction, packaged in sachets and dissolved in 60 ml of hot water as a single daily dose
Arm III will receive metformin 500 mg orally twice daily after meals with 240 ml of water. The intervention period will last 12 weeks, followed by post-treatment assessments at 1 and 3 months without
Sponsors
University of Colombo
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-70 years. 2. Diagnosed with T2DM for at least 6 months, confirmed by medical records and HbA1c levels. 3. HbA1c levels between 7.0% and 9.5% at screening, despite receiving stable doses of metformin or no metformin therapy for at least 3 months. 4. Willing and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Type 1 Diabetes Mellitus or other specific types of diabetes. 2. History of severe hypoglycaemia requiring hospitalization in the past 6 months. 3. Pregnant or breastfeeding women. 4. Active liver disease (defined as AST or ALT > 3 times the upper limit of normal). 5. Estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m². 6. Known allergy or intolerance to GS or metformin. 7. Currently using any other investigational drugs or herbal supplements for diabetes management.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c levels measured by venous blood test at baseline and 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in fasting blood glucose levels measured by venous blood test at baseline and 12 weeks, and random blood sugar (RBS) every two weeks using a glucometer strip test. 2. Change in insulin sensitivity (HOMA-IR) calculated from fasting glucose and fasting insulin levels at baseline and 12 weeks. 3. Incidence and severity of gastrointestinal side effects assessed using patient interviews and symptom questionnaires at each follow-up visit (baseline, 4 weeks, 8 weeks, and 12 weeks). 4. Change in body weight and BMI measured using a calibrated scale and stadiometer at baseline and 12 weeks. 5. Change in liver enzyme levels (ALT, AST) at baseline and 12 weeks. 6. Serum creatinine levels at baseline and 12 weeks. 7. Estimated glomerular filtration rate (eGFR) calculated from serum creatinine at baseline and 12 weeks. | — |
Countries
Sri Lanka
Contacts
Public ContactPathirage Kamal Perera
Outcome results
None listed