A trial to study efficacy of FFDP capsules in diabetic patients

An open labelled multi-centric clinical trial of safety and efficacy of Feijoa freeze dried powder (FFDP) capsules in treated uncontrolled type 2 diabetic patients

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/12/038559

Enrollment

Registered

2021-12-10

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Feijoa fruit Extract Powder Capsules: Feijoa fruit- freeze dried powder in capsules. Two capsules (400 mg per capsule) thrice a day for 3 months Control Intervention1: NA: NA

Eligibility

Inclusion criteria

Inclusion criteria: 1.Type 2 DM patients (with duration of diabetes > 6 months) and treated with oral hypoglycemic medicines. HbA1c between 7 %to 9% . 2.Patients in the age group between 19 to 65 years, of either sex. 3.Willing to give informed consent.

Exclusion criteria

Exclusion criteria: 1.Type 1 DM patients. 2.Type 2 diabetic patients on insulin 3.Pregnant women with diabetes 4.Lactating mothers with diabetes 5.Patient with uncontrolled diabetes, FBG >250mg% or PPBS >400mg% and/or HbA1c > 9.0. 6.Patient with uncontrolled dyslipidemia (fasting S. cholesterol >260mg% and S. triglycerides > 300mg% on screening visit) 7.Patient with presence of any severe diabetic complication and/or major systemic disease. 8.S. Creatinine >1.5%. 9.ASAT and ALT >2.5times the upper normal limits. 10.Patients with recent stroke or unstable angina or coronary artery diseases in previous 6 months before inclusion. 11.Presence of ketone bodies in urine analysis. 12.Haemoglobin level below 10 gm%. 13.History of substance abuse or alcoholism, within the previous one year. 14.Patient with seropositive status. 15.Patients who are on corticosteroids or oral contraceptives. 16.Participation in clinical trials evaluating investigational pharmaceuticals or biologics within 3 months or devices within 30 days of admission to the study. 17.Persons who have suffered from HIV/COVID, patients with Hepatitis C as per information given by patients

Design outcomes

Primary

Measure	Time frame
1. Reduction in plasma glucose (fasting and/or post prandial) 2. Reduction in HbA1c 3. Reduction in S.TC, TG, and LDL.Timepoint: 3 months	—

Secondary

Measure	Time frame
1. Change (increase /decrease) in HOMA IR and HOMA Beta indices 2. Reduction in proinflammatory cytokines (hsCRP) 3. Reduction in oxidant damage (Reduction in oxidized LDL) 4. Change in adiponectin, and C-peptide, insulin and HDL.Timepoint: 3 months	—

Countries

India

Contacts

Public ContactDr Shashank Jadhav

Kasturba Health Society Medical Research Centre

drshobhaudipi@gmail.com02226246119

Outcome results

None listed

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