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A clinical study to evaluate anti-diabetic effect and other health benefits of guava leaf extract in patients with diabetes mellitus

Anti-diabetic and pleiotropic effects of Psidium guajava Linn. leaf extract as an add-on treatment in patients with type 2 diabetes mellitus - A randomized double blind placebo controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036656
Enrollment
150
Registered
2021-09-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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: Psidium guajava Linn. leaf extract: Psidium guajava Linn. leaf extract 600 mg capsule thrice daily orally for 3 months in addition to background oral hypoglycaemic agents Control Interv

Sponsors

JIPMER Puducherry
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with type 2 Diabetes mellitus aged 18 years and above, irrespective of gender, who fulfil the following criteria - Patients on treatment with stable dose of oral hypoglycaemic agents for atleast 2 months and have not yet attained target HbA1c goal of less than 7% and not requiring dose escalation or addition of second anti-diabetic agent according to clinical judgment of the treating physician

Exclusion criteria

Exclusion criteria: • Patients on/requiring insulin therapy. • Patients not on stable dose of oral hypoglycemic drugs for past 2 months • HbA1c >9% • Pregnant and lactating women, women in reproductive age group not practicing contraceptive measures. • Patients with hepatic impairment (elevated liver enzymes >2 times upper normal limit) • Patients with renal impairment (S.Creatinine > 1.2 mg/dL) • Patients with recent history of Coronary artery disease within past 6 months. • Patients with peripheral vascular disease. • Patients who had participated in other trials in the past three months. • Patients on other herbal medications.

Design outcomes

Primary

MeasureTime frame
Mean reduction in HbA1C from baseline at the end of 3 monthsTimepoint: 3 months—

Secondary

MeasureTime frame
Mean change from baseline in fasting blood glucose, serum insulin, HOMA-IR, oxidative stress markers and antioxidant levels, liver and renal function , adiponectin, hs-CRP, lipid profile and endothelial function using plethysmography at the end of 3 monthsTimepoint: 3 months;Safety of Psidium guajava Linn. leaf extract in type-2 diabetes mellitus patients.Timepoint: 3 months—

Countries

India

Contacts

Public ContactDr Rosha Sandesh

Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER), Puducherry

dr.harivenkatesh82@gmail.com9968856995

Outcome results

None listed

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