Clinical evaluation of Diabepal tablet in comparison with Placebo tablet in Type 2 Diabetic Patients

A Clinical Evaluation of Efficacy and Safety of Tablet DIABEPAL as an Add-on therapy with Oral Hypoglycemic Agent (OHA) in Type 2 Diabetic Patients - A Randomized, Single-center, Double Blind, Placebo Controlled Study - NIL

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/10/005076

Enrollment

Registered

2014-10-07

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: null- Type 2 Diabetes Mellitus

Interventions

Intervention1: DIABEPAL TABLET: It contains Gudmar Ext (Gymnema sylvestrae), Vijaysaar Ext (Pterocarpus marcipium), Methi Ext (Trigonella foenum graecum), Jamun Ext (Eugenia jambolana), Karela Ext (M

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects suffering from Type 2 Diabetes Mellitus for more than one year, 2. Subject stabilized on mono/ polydrug anti-diabetic therapy for at least last 3 months. 3. Subjects having their fasting blood glucose in the range of 126 -252 mg/dl on screening visit 4. HbA1C in range of 7-11% 5. Subjectâ??s ECG not demonstrating any signs of uncontrolled arrhythmia / acute ischemia 6. Subjects with controlled blood pressure and controlled lipid levels

Exclusion criteria

Exclusion criteria: 1.Subjects on insulin therapy 2.Subjects suffering from type-1 DM or types of Diabetes mellitus other than Type -2 3.Subjects having known hepatic or renal disease 4.Subjects having an active malignancy 5.Subjects with history of significant cardiovascular event 6.Subjects having known major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds

Design outcomes

Primary

Measure	Time frame
1.Monthly changes in fasting & postprandial plasma glucose levels 2.Changes in HbA1C% (Glycosylated Hemoglobin) value Timepoint: Baseline value, value on 30th day, 60th day, and 90th day of treatment 2.Changes in HbA1C% (Glycosylated Hemoglobin) value	—

Secondary

Measure	Time frame
1.Quality of Life (QOL) of patients will be done using WHO-QOL 2.Changes in Serum insulin level 3.Reduction or increase in dose of OHAs 4.Clinical symptoms of Type 2 DM i.e. Polydypsia, Polyphasia, Polyurea, & fatigue 5.Global assessment for overall improvement will be done by the investigator and by the patient himself / herself on study completion Timepoint: Baseline value, value on 30th day, 60th day, and 90th day of treatment	—

Measure

Time frame

1.Quality of Life (QOL) of patients will be done using WHO-QOL 2.Changes in Serum insulin level 3.Reduction or increase in dose of OHAs 4.Clinical symptoms of Type 2 DM i.e. Polydypsia, Polyphasia, Polyurea, & fatigue 5.Global assessment for overall improvement will be done by the investigator and by the patient himself / herself on study completion Timepoint: Baseline value, value on 30th day, 60th day, and 90th day of treatment

—

Countries

India

Contacts

Public ContactDr Arjun Kohli

ARJUN HEALTHCARE

arjunhealthcare2012@gmail.com8108829777

Outcome results

None listed

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