| CTRI Number |
CTRI/2024/05/067188 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
09/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Tab Glucitox in the management of Diabetis Mellitus |
|
Scientific Title of Study
|
Evaluation of Efficacy of Tab.Glucitox in Patients of type 2 Diabetes Mellitus |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAshish Hasuram Mhatre |
| Designation |
Associate Professor Kayachikitsa |
| Affiliation |
D.Y.PATIL DEEMED TO BE UNIVERSITY,SCHOOL OF AYURVEDA NERUL NAVIMUMBAI |
| Address |
D.Y.PATIL DEEMED TO BE UNIVERSITY,SCHOOL OF AYURVEDA Sector 7,Dr.D.Y.Patil Vidyanagar Nerul,Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9819639895 |
| Fax |
|
| Email |
ashishmhatre2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAshish Hasuram Mhatre |
| Designation |
Associate Professor Kayachikitsa |
| Affiliation |
D.Y.PATIL DEEMED TO BE UNIVERSITY SCHOOL OF AYURVEDA NERUL NAVIMUMBAI |
| Address |
D.Y.PATIL DEEMED TO BE UNIVERSITY,SCHOOL OF AYURVEDA NERUL NAVIMUMBAI
Thane
MAHARASHTRA
400706
India |
| Phone |
9819639895 |
| Fax |
|
| Email |
ashishmhatre2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archana Kashid |
| Designation |
Assistant Professor Kayachikitsa |
| Affiliation |
D.Y.PATIL DEEMED TO BE UNIVERSITY SCHOOL OF AYURVEDA NERUL NAVIMUMBAI |
| Address |
D.Y.PATIL DEEMED TO BE UNIVERSITY,SCHOOL OF AYURVEDA NERUL NAVIMUMBAI
Thane
MAHARASHTRA
400706
India |
| Phone |
9987988741 |
| Fax |
|
| Email |
archana.kashid@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| KUSINARA WELLNESS PVT LTD
D Y Patil Ayurvedic Hospital Nerul Navi Mumbai are source/s of monetary or material support |
|
|
Primary Sponsor
|
| Name |
Kusinara Wellness Pvt Ltd |
| Address |
Flat no C/03, Plot no. 34, Nandanvan CHS.LTD. Sector 17, Nerul(East), Navi Mumbai MUMBAI MUMBAI Thane MH 400706 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ASHISH MHATRE |
D Y PATIL AYURVEDIC HOSPITAL NAVI MUMBAI |
Department of Kayachikitsa OPD no 1 First floor ,SECTOR 7 NERUL NAVI MUMBAI pin 400706
Thane
MAHARASHTRA |
9819639895
ashishmhatre2010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE D Y PATIL DEEMED TO BE UNIVERSITY SCHOOL OF AYURVEDA NERUL NAVI MUMBAI |
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. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: tab glucitox, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Confirmed case of DM (NIIDDM or Type II DM)
Uncomplicated
Fasting BSL more than 125mg/dl less than or equal to 200mg/dl
PP BSL more than 200mg/dl equal to or less than 400mg/dl
HbA1c more than 7 % and 10 %
Patients with informed written consent |
|
| ExclusionCriteria |
| Details |
Blood sugar more than 400mg/dl,preganancy and lactating mothers,complications like hyperglycemic coma,ketoacidosis ,DM Neuropathy,retinopathy ,neuropathy ,Malignancy ,CVS disorders
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
glycaemic control (measured by glycosylated haemoglobin A1c (HbA1c) and fasting blood glucose levels)
|
2months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of adverse event by clinical evaluation, AE/SAE recording, Vitals and Lab Parameters ,Assessment of clinical global evaluation for overall efficacy by physician and by the patient ,
Assessment of overall acceptability/tolerability by Subject and physician
|
2months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/05/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title-Evaluation of Efficacy of Tab.Glucitox in Patients of type 2 Diabetes Mellitus, Objective - The objective of the study is to evaluate the efficacy and safety of Tab.Glucitox in Patients of type 2 Diabetes Mellitus Primary Outcome:- glycaemic control (measured by glycosylated haemoglobin A1c (HbA1c) and fasting blood glucose levels); 2. health-related quality of life Secondary Objectives : Assessment of adverse event by clinical evaluation, AE/SAE recording, Vitals and Lab Parameters , Assessment of clinical global evaluation for overall efficacy by physician and by the patient study group- open randomized study sample size -50 Dose -tab.Glucitox 1 TDS for 8 weeks Visit Schedule-0th day . 15th day, 3OTH DAY ,45 TH DAY ,60 TH DAY Inclusion criteria- 1. Confirmed case of DM (NIDDM / TYPE II Diabetes Mellitus) 2. Both sexes 3. Uncomplicated 4. Age between 30 yrs to 65 yrs old 5.fasting blood sugar more than 125mg/dl 5.post-prandial blood sugar more than 200mg/dl ,HBA1c between 7 to 10 % exclusion criteria - blood sugar more than 400mg/dl ,preganancy and lactating mother, complications like diabetic neuropathy,retinopathy,nephropathy m maliganancy , CVS disoders
|