| CTRI Number |
CTRI/2019/10/021595 [Registered on: 10/10/2019] Trial Registered Prospectively |
| Last Modified On: |
11/03/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluate Partial Meal Replacement with Prohance D (Nutraceutical Product) in type II Diabetic Population |
|
Scientific Title of Study
|
Open Label, Randomized, Controlled Study to Evaluate Partial Meal Replacement Program with Prohance D Targeting Glycemic levels and Weight control in type II Diabetic Population |
| Trial Acronym |
ET1903001 |
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhaumik Mody |
| Designation |
Overall study coordinator |
| Affiliation |
Director |
| Address |
Ethitrials Contract Research Pvt. Ltd., India,916, Devpath Complex,B/H Lal Bungalow, Off C.G. Road, Navrangpura,
Ahmadabad
Ahmadabad
GUJARAT
380009
India |
| Phone |
917966174411 |
| Fax |
|
| Email |
bhaumik.mody@ethitrials.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Medical Monitor |
| Affiliation |
Medical Monitor |
| Address |
Ethitrials Contract Research Pvt. Ltd., India,916, Devpath Complex,B/H Lal Bungalow, Off C.G. Road, Navrangpura,
Ahmadabad
Ahmadabad
GUJARAT
380009
India |
| Phone |
917966174411 |
| Fax |
|
| Email |
nayan.patel@ethitrials.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nayan Patel |
| Designation |
Medical Monitor |
| Affiliation |
Medical Monitor |
| Address |
Ethitrials Contract Research Pvt. Ltd., India,916, Devpath Complex,B/H Lal Bungalow, Off C.G. Road, Navrangpura,
Ahmadabad
Ahmadabad
GUJARAT
380009
India |
| Phone |
917966174411 |
| Fax |
|
| Email |
nayan.patel@ethitrials.com |
|
|
Source of Monetary or Material Support
|
| Sun Pharma Industries Limited
Sun House, 201 B/1, Western Express Highway, Goregaon (East), Mimbai, Maharashtra (India) - 400063 |
|
|
Primary Sponsor
|
| Name |
Sun Pharma Industries limited |
| Address |
Sun House, 201 B/1, Western Express Highway, Goregaon (East), Mumbai, Maharashtra (India)-400063 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rupam Das |
Downtown Hospital |
Room number 1111, Department of Endocrinology, Downtown Hospital, Dispur, GS Road, Guwahati 781006
Kamrup
ASSAM |
361-2331-003
rupamdas_in@yahoo.com |
| Dr Manoj Gupta |
Health point Hospital |
Room Number 12 Clinical Research room OPD Building 1st Floor, 21 Prannath pandit Street opposite Lansdowne Padmapukar Kolkatta-700025,
Kolkata
WEST BENGAL |
033-30575700
manojsrmc@gmail.com |
| Dr Arvind Kumar Mishra |
King Georges medical University |
Room number 213 Deapartment of medicine King Georges Medical University Chowk Lucknow 226003
Lucknow
UTTAR PRADESH |
9415005723
anuarvindmisra@yahoo.com |
| Dr Sandeep Jain |
Marudhar Hospital |
Room No. 102, Consultant Physician, A 93-99, Singh Bhoomi, Khatipura Road, jaipur, Rajasthan 302012
Jaipur
RAJASTHAN |
9414069583
drsandeeprjain@yahoo.co.in |
| Dr Mala Dharmalingam |
MS Ramaih Hospital Bangalore |
Room number 103, Department of Endocrinology, Ms Ramiah Hospital Bangalore 560054
Bangalore
KARNATAKA |
080-22183025
drmaladharmalingam@gmail.com |
| Dr Sachin Gupta |
Shubham Multispeciality Hospital |
Room no. 01 Shubham Multispeciality Hospital, ABC Complex, Near Rabari Colony Cross Road, Amraiwadi, Ahmadabad-380026
Ahmadabad
GUJARAT |
079-22870709
drsachingupta_21@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee Down Town Hospital |
Approved |
| Health Point Ethics Committee |
Approved |
| Institutional Ethics Committee Kings George Medical University |
Submittted/Under Review |
| Marudhar Hospital Ethics Committee |
Approved |
| SCCMH- Institutional Ethics Committee |
Approved |
| Shubham Institutional Ethics Committee |
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 |
| Comparator Agent |
Placebo |
No treatment |
| Intervention |
Prohance D Vanilla Flavour (Nutraveutical Product) |
once a day for 12 week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age : 18 – 65 years inclusive, Male and non-pregnant females
2. Diagnosis of Type 2 Diabetes Mellitus since at least 1 year, treated with stable dose of oral anti-diabetic drugs (drugs permitted include: metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, GLP1 agonists) for at least month before screening
3. Patients with HbA1c from 6.5 to 10 %
4. Body mass index (BMI) :- 23 – 34 kg/m2 and as per consensus statement for Asian Indians for obesity
5. Patient willing to provide informed consent and willing to comply
|
|
| ExclusionCriteria |
| Details |
1. Type I Diabetes Mellitus & Type 2 Diabetes Mellitus patient on basal or multiple injections
2. Allergy to one or more components of the study product or history of food allergies
3. Patient receiving any diabetes specific nutritional food supplement that does not include multivitamin supplements (Except Ca/Vit D supplements and B complex syrups) within 15 days prior to study start.
4. Patient taking any herbal/Ayurvedic Traditional preparation that could profoundly affect blood glucose
5. Females who are nursing / pregnant / are of child - bearing potential and not practicing an acceptable method of birth control / or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial.
6. Patient has evidence or history of clinically significant hematological, renal,endocrine,pulmonary,gastrointestinal,cardiovascular,hepatic,psychiatric, neurologic or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
7. Patient with impaired hepatic function as defined by serum levels of alanine transaminase (SGPT), aspartate transaminase (SGOT), alkaline phosphatase 3× ULN (Upper Limit of Normal), total bilirubin 1.50 x ULN in the past 1 year Patient has a history of jaundice in the past 1 year Patient has a impaired renal function, as defined by serum creatinine - 1.4 for women and 1.5 for men, in the past 1 year.
8. Patient has a history of acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV) infection.
9. Patient has a history of severe diabetic neuropathy including autonomic neuropathy, gastroparesis or lower limb ulceration or amputation or evidence or history of diabetic complications with significant end organ damage.
10. Patient has a history of illicit drug or alcohol abuse within last 1 year.
11. Patients on therapy with the following drugs will not be permitted to participate in the trial: glucocorticoids, pentamidine, nicotinic acid, diazoxide, adrenergic agonists, hydantoins, asparaginase, interferon, antipsychotics (atypicals and others), epinephrine, anti-secretory agents, cyclosporine, tacrolimus, digoxin, quinine, salicylates, multivitamins, high-ceiling diuretics, appetite stimulants, progestational agents, growth hormones, other anabolic agents, sibutramine, orlistat, rimonabant and drugs which will affect folate metabolism, currently or within past 3 months from the time of informed consent.
12. Patient has a history of any condition possibly affecting absorption of study product.
13. Patient has received any investigational drug within 30 days (or 5 half-lives of the investigational drug, whichever is greater) prior to study start.
14. has any major or minor surgery within 30 days prior to screening.
15. Patient has a history or confirmed diagnosis of malignancy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Glycemic Control after using Prohance-D |
Baseline to Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Post Prandial Glucose |
Baseline to week 06 and 12 week |
| Change in Weight |
Baseline to week 06 and 12 week |
| Change in Lipid Profile |
Baseline to week 06 and 12 week |
| Change in Waist Circumference |
Baseline to week 06 and 12 week |
| Change in Fasting Glucose |
Baseline to week 06 and 12 week |
| Assess quality of life parameters (e.g. Adherence, Compliance, Sateity measurement, Energy fulfillment, taste) |
Baseline to week 06 and 12 week |
| Safety monitoring by AE assessment including hypoglycemia |
Throughout the study period |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
22/10/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is design to evaluate the safety and efficacy f Partial meal replacement program with Prohance D (Nutraceutical Product) targeting Glycemic levels and weight control in type II Diabetic patients. This
is an open label, randomized, multi-center, controlled, post marketing study in 200 Indian patients. The study will include at least 3 evaluation points: Baseline/Enrollment
Visit and patient assessments at 06 weeks and 12 weeks
after randomization. Eligible patients meeting inclusion/exclusion criteria
will be enrolled in selected sites to evaluate effect on Weight and Glycemic
Control. Test
arm (n=100) will receive Prohance-D Vanilla Flavor as supplemental meal.
Control arm (n=100)
will not receive any meal replacement. Study
will collect data at baseline, week 06 and week 12. There are no study-prescribed
procedures for this study. Because of the “real world†setting of the study,
any procedure ordered by the physician during this study will be one that is
appropriate to the routine care delivered to the subject at the discretion of
the participating physician.
Subjects will be under direct
medical care during the entire study period. The time points of interest for
data collection are baseline at introduction of Study product, Week 06 and week
12 (End of study)
Efficacy Variables will be measures as Glycemic Control and weight control after using Prohance D, Change in Lipid profile, Change in Waist Circumference, Change in Fasting and post Prandial Glucose and assess quality of life parameters from baseline of the study at each time point. Safety analysis include Monitoring of AE including hypoglycemia throughout the study period. |