Safety and efficacy of a ready-to-drink Gymnema product in T2DM

Evaluation of Safety and efficiency of ready-to-drink gymnema product in patients with type 2 diabetes

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20251031005

Enrollment

Registered

2025-10-31

Start date

2023-08-04

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus (T2DM) Gymnema inodorum Chiang Da Mulberry Chamomile Herbal beverage Type 2 diabetes mellitus Glycemic control Antioxidant Safety Clinical trial

Interventions

The investigational product is a ready-to-drink herbal beverage, 1 bottle (150 mL) per day, once daily, 30 minutes after breakfast, for 12 consecutive weeks. The product is composed of 85% Gymnema ino

Experimental Other,Experimental Other

Group A

1 bottle per day,Group B

2 bottles per day

Eligibility

Sex/Gender

All

Age

25 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Adults aged 25-60 years. 2.Diagnosed with type 2 diabetes mellitus (T2DM) within the past six months. 3.Fasting blood glucose (FBS) more than 126 mg/dL and HbA1C more than 6.5%. 4.Currently receiving stable oral metformin therapy. 5.Not using herbal or dietary supplements with glucose-lowering effects within the past four weeks. 6.Able and willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women. 2. Known allergy to Gymnema inodorum or related plant species. 3. Current use of insulin therapy. 4. Presence of chronic liver, kidney, or hematologic disorders. 5. Active malignancy or psychiatric illness. 6. Substance or alcohol dependence. 7. Current use of anticoagulant medications. 8. Participation in another clinical trial within the past three months.

Design outcomes

Primary

Measure	Time frame
Complete Blood Count Day 0 and Week 12 Hematological test,Blood Biochemical Indicators (Liver Function Tests, Renal Function Tests, HbA1C) Day 0 and Week 12 Hematological test,Fasting blood glucose Day 0 and Week 12 Glucometer,2-hour postprandial glucose Day 0 and Week 12 OGTT,Fasting Insulin Day 0 and Week 12 Enzyme-Linked Immunosorbent Assay (ELISA),HOMA-IR, HOMA-S, HOMA-Beta Day 0 and Week 12 Calculation Formula	—

Measure

Time frame

Complete Blood Count Day 0 and Week 12 Hematological test,Blood Biochemical Indicators (Liver Function Tests, Renal Function Tests, HbA1C) Day 0 and Week 12 Hematological test,Fasting blood glucose Day 0 and Week 12 Glucometer,2-hour postprandial glucose Day 0 and Week 12 OGTT,Fasting Insulin Day 0 and Week 12 Enzyme-Linked Immunosorbent Assay (ELISA),HOMA-IR, HOMA-S, HOMA-Beta Day 0 and Week 12 Calculation Formula

—

Secondary

Measure	Time frame
Body Composition Day 0 and Week 12 Anthropometry,AGEs Day 0 and Week 12 Enzyme-Linked Immunosorbent Assay (ELISA	—

Countries

Thailand

Contacts

Public ContactSakaewan Ounjaijean

Chiang Mai University

sakaewan.o@cmu.ac.th053942508

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026