A clinical study to evaluate antidiabetic and other effects of mango leaf extract in patients with type 2 diabetes mellitus

Antidiabetic and pleiotropic effect of Mangifera indica Linn. leaf extract as an add-on treatment in patients with type 2 diabetes mellitus- A randomized double blind placebo controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075971

Enrollment

150

Registered

2024-10-28

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: E11- Type 2 diabetes mellitus

Interventions

Intervention1: Mangifera indica leaf extract: Mangifera indica leaf extract 600 mg capsule thrice daily orally in addition to background standard hypoglycemic agents for a period of 3 months Control I

Eligibility

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes mellitus aged = 18 years, irrespective of gender, who fulfill the following criteria: Patients receiving stable dose of OHA for at least 2 months before study and have not yet attained target glycemic goals and not requiring dose escalation or addition of another antidiabetic agent according to the clinical judgement of the treating physician

Exclusion criteria

Exclusion criteria: Patients on or requiring insulin therapy. Patients not on stable dose of OHA for past 2 months. Patients with uncontrolled blood glucose levels. Pregnant and lactating women, women in reproductive age group not practicing contraceptive measures. Patients with recent history of coronary artery disease within past 6 months. Patients with peripheral vascular disease. Patients with hepatic or renal impairment (elevated liver enzymes more than 2 times upper normal limit or serum creatinine more than 1.2 mg per dl). Patients using other herbal medications. Patients who had participated in other trials in past 3 months.

Design outcomes

Primary

Measure	Time frame
Mean change from baseline in HbA1c levels at the end of 3 monthsTimepoint: 3 months	—

Secondary

Measure	Time frame
Mean change from baseline in FBS, serum insulin, HOMA-IR, oxidative stress markers, antioxidant levels, liver and renal function tests, lipid profile, adiponectin, hs-CRP and endothelial function using plethysmography at the end of 3 months.Timepoint: 3 months;safety of Mangifera indica leaf extract in patients with type 2 diabetes mellitus.Timepoint: 3 months	—

Countries

India

Contacts

Public ContactDr Brindashree B G

JIPMER, Puducherry

dr.harivenkatesh82@gmail.com9968856995

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026