| CTRI Number |
CTRI/2019/05/019027 [Registered on: 09/05/2019] Trial Registered Prospectively |
| Last Modified On: |
05/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical trial to assess the Safety and Efficacy of NRL/LP/201901 as Adjuvant Therapy in patients with Type 2 DM. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/19-20/001 Ver. 1.0 dated 27 Mar 2019. |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amar Raikantiwar |
| Designation |
Consultant |
| Affiliation |
Lokmanya Medical Research Center |
| Address |
OPD 2 Floor 4 Lokmanya Medical Research Center
314/B Telco Road Chinchwad Pune 411033
Pune
MAHARASHTRA
411033
India |
| Phone |
8451941050 |
| Fax |
|
| Email |
dr.raikantiwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Omkar Kulkarni |
| Designation |
Senior Manager, Research and Development |
| Affiliation |
Netsurf Research Labs Pvt Ltd |
| Address |
107, Plot 2, Laxman Nagar, Baner Road,
Baner, PUNE 411045 (Maharashtra) India.
Pune
MAHARASHTRA
411045
India |
| Phone |
020-67111212 |
| Fax |
|
| Email |
omkar.kulkarni@nrl.net.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Omkar Kulkarni |
| Designation |
Senior Manager, Research and Development |
| Affiliation |
Netsurf Research Labs Pvt Ltd |
| Address |
107, Plot 2, Laxman Nagar, Baner Road,
Baner, PUNE 411045 (Maharashtra) India.
MAHARASHTRA
411045
India |
| Phone |
020-67111212 |
| Fax |
|
| Email |
omkar.kulkarni@nrl.net.in |
|
|
Source of Monetary or Material Support
|
| Netsurf Communications Pvt Ltd
Sr. No. 107, Plot No. 2, Baner Road, Baner.
Pune- 411 045, India |
|
|
Primary Sponsor
|
| Name |
Netsurf Communications Pvt Ltd |
| Address |
107, Plot 2, Laxman Nagar, Baner Road,
Baner, PUNE 411045 (Maharashtra) India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Medha Kulkarni |
Dr. D.Y. Patil College of Ayurved and Research Centre |
Sant Tukaram Nagar Pimpri Pune 411 018
Pune
MAHARASHTRA |
9890355305
drmedhak2@gmail.com |
| Dr Amar Raikantiwar |
Lokmanya Medical Resaerch Centre |
OPD 2 Foor 4
314/B Telco Road
Chinchwad Pune 411033
Pune
MAHARASHTRA |
8451941050
dr.raikantiwar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Dr. D. Y. Patil College of Ayurved and research center |
Approved |
| Lokmanya Medical Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 hypoglycemic agents. Subjects will be advised lifestyle modifications (nutritious diet, exercise etc.) |
| Comparator Agent |
Placebo |
Subjects will be advised to consume placebo Capsules twice daily orally 15 min before meal with lukewarm water for 3 months along with the ongoing treatment of oral hypoglycemic agents. Subjects will be advised lifestyle modifications (nutritious diet, exercise etc.) |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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)
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
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) |
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
|
| Outcome |
TimePoints |
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) |
Subjective assessment in each follow up ie week 0, 4,8 and 12
Biochemical changes from Baseline in lipid profile to Week 12 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
13/05/2019 |
| Date of Study Completion (India) |
04/11/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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 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 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 Plasma
Glucose (FPG) 2. Change from Baseline in 2-hr Post-Meal
Glucose (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-Meal
Insulin (PMI) Along with some secondary objectives like- 1. To
evaluate changes of the b-cell functions (homeostasis model assessment
[HOMA]-b, insulin resistance (IR) by HOMA-IR,
2. To
evaluate changes in anthropometric parameters
3. To
evaluate change in inflammatory marker like C-peptide
4. To evaluate tolerability Diabetes Support
Capsules in patients with Type 2 DM.
5. To evaluate safety of Diabetes Support
Capsules in patients with Type 2 DM withrepect to renal, liver and lipid
function test.
6. Adverse event profiling for Diabetes Support
Capsules
7. Quality of Life Instrument for Indian Diabetes
Patients (QOLID) |