| CTRI Number |
CTRI/2019/09/021126 [Registered on: 09/09/2019] Trial Registered Prospectively |
| Last Modified On: |
08/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
To determine safety and efficacy of Cap. Hintosulin in drug naïve pre-diabetics and in Type-2 Diabetic patients on OHA |
|
Scientific Title of Study
|
Two arm, prospective study to determine safety and efficacy of Cap. Hintosulin in drug naïve pre-diabetics and in Type-2 Diabetic patients on OHA in decreasing blood sugar levels. |
| Trial Acronym |
HinQuest-DM01 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HinQuest-DM01_Version 1.0_26-Jul-19 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jitendra Agrawal |
| Designation |
Principal Investigator |
| Affiliation |
Suryaprabha Nursing home |
| Address |
First floor, Medicine OPD,
Plot No 7 paud road, Gujrat colony kothrud Pune
Pune
MAHARASHTRA
411038
India |
| Phone |
08805598244 |
| Fax |
|
| Email |
jka29405@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharvari Rangnekar |
| Designation |
Director |
| Affiliation |
Quest Clinical Services |
| Address |
Quest Clinical Services
14 Samata Ganesh nagar chinchwad pune
Pune
MAHARASHTRA
411033
India |
| Phone |
9890229919 |
| Fax |
|
| Email |
questclinicalservices@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharvari Rangnekar |
| Designation |
Director |
| Affiliation |
Quest Clinical Services |
| Address |
Quest Clinical Services
14 Samata Ganesh nagar chinchwad pune
Pune
MAHARASHTRA
411033
India |
| Phone |
9890229919 |
| Fax |
|
| Email |
questclinicalservices@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ishaana Nutraceutical Pvt. Ltd.Selaqui G/86, UPSIDC industrial area, Dehradun, Uttarakhand, 248001 |
|
|
Primary Sponsor
|
| Name |
Ishaana Nutraceutical Pvt Ltd |
| Address |
Selaqui G/86, UPSIDC industrial area, Dehradun, Uttarakhand, 248001 |
| Type of Sponsor |
Other [Nutraceutical company ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepak Bhosale |
Devgiri Diabetic center |
46, Samata Nagar, Near Kranti Chowk, Aurangabad,431001
Aurangabad
MAHARASHTRA |
7770087870
drdeepakbhosle@gmail.com |
| Dr Shital R karnawat |
Karnawat Superspecialty clinic |
Third Floor, Suyojit Sankul Near Rajiv Gandhi Bhavan, Sharanpur Rd, Sharanpur, 422002
Nashik
MAHARASHTRA |
8446353531
shitalkarnawatkem@yahoo.com |
| Dr Jitendra Agrawal |
Suryaprabha Nursing Home |
Medicine OPD, First Floor, Suryaprabha Nursing Home, Plot No 7 Paud road, Gujrat colony, Kothrud, Pune
Pune
MAHARASHTRA |
9890025762
jka29405@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Royal Pune Independent 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 |
Cap. Hintosulin
(it is the same. As, two groups are based on clinical conditions and not on the intervention.) |
Dose-1 capsule
Frequency- twice a day
Duration- 90 Days
Route-Oral
It is a nutraceutical product, food for special dietary use |
| Intervention |
Cap. Hintosulin |
Dose-1 capsule
Frequency- twice a day
Duration- 90 Days
Route-Oral
It is a nutraceutical product, food for special dietary use |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject having BSL (F) between 100 and 125 and is not a known diabeticOR subject is a known case of T2DM and is on oral anti-diabetic treatment
2. No change in anti-diabetic treatment for the last one month if not detected DM in last month
3. Between Age group of 18 and 70 years
4. Both male and female patients will be included
|
|
| ExclusionCriteria |
| Details |
1. Diabetes other than type 2 diabetes mellitus
2. Patients having complications of diabetes like diabetic neuropathy, retinopathy, nephropathy, ketoacidosis.
3. Participation in any other clinical trial within the last 30 days
4. Pregnant or breast-feeding woman
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Cap. Hintosulin for management of blood sugar levels in drug naïve pre diabetics and and in Type-2 Diabetic patients |
Day 15, 30, 60 and 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess efficacy of Cap. Hintosulin in delaying oral hypoglycemic agents (OHA) in drug naïve pre diabetic patients.
To access efficacy of Cap. Hintosulin in OHA dependent T2DM patients inmodifying OHA and / or its dose.
To access safety of Cap. Hintosulin in drug naïve pre-diabetics and in T2DM patients in terms of reported Adverse events |
Day 15, 30, 60 and 90 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/09/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective, open labelled, double arm, multi centric study, which will assess safety and efficacy of Cap. Hintosulin in reducing blood sugar levels. A total of 50 patients will be enrolled in the study (25 pre-diabetic and 25 known diabetic). 25 patients’ retrospective data of OHA dependent Type-2Diabetes patients will be collected as a retrospective control group. Patients enrolled in the study (prospective cohort) will get the Investigational Product (IP), which is, Cap. Hintosulin, with dose of 1 capsule two times daily for 90 days. Patients will undergo routine checkup and laboratory investigations. Blood sugar levels will be done during each scheduled visit, whereas HbA1c, renal function tests, liver function tests, hemogram will be done during enrollment and last (90 day) visit.
|