Clinical trial to assess the Safety and Efficacy of NRL/LP/201901 as Adjuvant Therapy in patients with Type 2 DM.

Randomised double blind, placebo controlled clinical trial to assess the Safety and Efficacy of NRL/LP/201901 capsules as Adjuvant Therapy in patients with Type 2 Diabetes Mellitus. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/05/019027

Enrollment

100

Registered

2019-05-09

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: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: NRL/LP/201901: Subjects will be advised to consume NRL/LP/201901 Capsules twice daily orally 15 min before meal with lukewarm water for 3 months along with the ongoing treatment of oral

Eligibility

Inclusion criteria

Inclusion criteria: Patients between 30-60 (both inclusive) age, both sex. Patients receiving Oral Hypoglycemic Agents as ongoing treatment for Type 2 DM . Hemoglobin A1c (HbA1c) >6.5% and Fasting Plasma Glucose (FPG) >130 mg/dL and

Exclusion criteria

Exclusion criteria: Type 1 diabetes. Under Insulin treatment Patients with concurrent serious Hepatic Dysfunction (defined asAST and/or ALT >3 times of the upper normal limit) or RenalDysfunction (defined as S. creatinine >1.4 mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease. Women who are pregnant or lactating Smokers/Alcoholics and/or drug abusers Patients with evidence of malignancy Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro- Endocrinal disorders, etc.) Involvement in any other study requiring drug therapy Renal dysfunction as evidenced by raised serum creatinine from renal function test History of serious arrhythmia or atrioventricular block on baseline electrocardiogram Uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg) Unwillingness to undergo therapy

Design outcomes

Primary

Measure	Time frame
To assess change from Baseline in Fasting Plasma Glucose (FPG) To assess change from Baseline in 2-hr Post-Meal Glucose (PMG) To evaluate change from Baseline in Haemoglobin A1c (HbA1c) at Week 12 (End of study). To assess change from Baseline in Fasting Insulin (FI) To assess change from Baseline in 2-hr Post-Meal Insulin (PMI)Timepoint: To assess changes in Fasting and post meal blood sugar from baseline, week4,8 and 12. Fasting and post meal To assess changes in Insulin, HbA1c baseline and end of study ie 12 week	—

Measure

Time frame

To assess change from Baseline in Fasting Plasma Glucose (FPG) To assess change from Baseline in 2-hr Post-Meal Glucose (PMG) To evaluate change from Baseline in Haemoglobin A1c (HbA1c) at Week 12 (End of study). To assess change from Baseline in Fasting Insulin (FI) To assess change from Baseline in 2-hr Post-Meal Insulin (PMI)Timepoint: To assess changes in Fasting and post meal blood sugar from baseline, week4,8 and 12. Fasting and post meal To assess changes in Insulin, HbA1c baseline and end of study ie 12 week

—

Secondary

Measure	Time frame
Changes of the b-cell functions [HOMA]-b, insulin resistance (IR) by HOMA-IR, To evaluate obesity (body weight),anthropometric parameters Change in inflammatory marker like C-peptide Safety of Diabetes Support Capsules in patients with Type 2 DM with repect to renal, liver and lipid function test. Adverse event profiling Quality of Life Instrument for Indian Diabetes Patients (QOLID)Timepoint: Subjective assessment in each follow up ie week 0, 4,8 and 12 Biochemical changes from Baseline in lipid profile to Week 12	—

Measure

Time frame

Changes of the b-cell functions [HOMA]-b, insulin resistance (IR) by HOMA-IR, To evaluate obesity (body weight),anthropometric parameters Change in inflammatory marker like C-peptide Safety of Diabetes Support Capsules in patients with Type 2 DM with repect to renal, liver and lipid function test. Adverse event profiling Quality of Life Instrument for Indian Diabetes Patients (QOLID)Timepoint: Subjective assessment in each follow up ie week 0, 4,8 and 12 Biochemical changes from Baseline in lipid profile to Week 12

—

Countries

India

Contacts

Public ContactDr Omkar Kulkarni

Netsurf Research Labs Pvt Ltd

omkar.kulkarni@nrl.net.in020-67111212

Outcome results

None listed

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