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

Phase 2

Completed

Conditions: Type 2 diabetes mellitus without complications,

Registration Number: CTRI/2019/05/019027

Lead Sponsor: Netsurf Communications Pvt Ltd

Brief Summary: Product coded NRL/LP/201901 will be assesed for its potential to be adjuvant in management of Diabetes type 2.

Subjects with Type 2 Diabetes mellitus will be advised toconsume NRL/LP/201901 Capsules twice daily orally15 min before meal with lukewarm water for 3 months along with the ongoingtreatment of oral hypoglycemic agents. Subjects will be advised lifestyle modifications(nutritious diet, exercise etc.) and same routine will be followed for the placebo arm as well.

Following parameters will be assessed to validate safety and efficacy of test product for total duration of 3 months ie 12 weeks with follow up every month

1. Change from Baseline in Fasting PlasmaGlucose (FPG)

2. Change from Baseline in 2-hr Post-MealGlucose (PMG)

3. Change from Baseline in Haemoglobin A1c(HbA1c) at Week 12 (End of study).

4. Change from Baseline in Fasting Insulin (FI)

5. Change from Baseline in 2-hr Post-MealInsulin (PMI)

Along with some secondary objectives like-

1. Toevaluate changes of the b-cell functions (homeostasis model assessment[HOMA]-b, insulin resistance (IR) by HOMA-IR,

2. Toevaluate changes in anthropometric parameters

3. Toevaluate change in inflammatory marker like C-peptide

4. To evaluate tolerability Diabetes SupportCapsules in patients with Type 2 DM.

5. To evaluate safety of Diabetes SupportCapsules in patients with Type 2 DM withrepect to renal, liver and lipidfunction test.

6. Adverse event profiling for Diabetes SupportCapsules

7. Quality of Life Instrument for Indian DiabetesPatients (QOLID)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

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 <10% (both inclusive) Fasting Plasma Glucose (FPG) >130 mg/dL and < 250 mg/dL (both inclusive).

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess change from Baseline in 2-hr Post-Meal Insulin (PMI)	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
To assess change from Baseline in Fasting Insulin (FI)	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
To assess change from Baseline in Fasting Plasma Glucose (FPG)	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
To assess change from Baseline in 2-hr Post-Meal Glucose (PMG)	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
To evaluate change from Baseline in Haemoglobin A1c (HbA1c) at Week 12 (End of study).	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 Outcome Measures

Name	Time	Method
Changes of the b-cell functions [HOMA]-b, insulin resistance (IR) by HOMA-IR,	To evaluate obesity (body weight),anthropometric parameters

Trial Locations

Locations (2): Dr. D.Y. Patil College of Ayurved and Research Centre
🇮🇳
Pune, MAHARASHTRA, India
Lokmanya Medical Resaerch Centre
🇮🇳
Pune, MAHARASHTRA, India
Dr. D.Y. Patil College of Ayurved and Research Centre
🇮🇳Pune, MAHARASHTRA, India
Dr Medha Kulkarni
Principal investigator
9890355305
drmedhak2@gmail.com