| CTRI Number |
CTRI/2009/091/000702 [Registered on: 10/09/2009] |
| Last Modified On: |
03/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Unani |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical trial to study the effects of a unani formulation 'Diabeat'in patients with high blood sugar levels (Type 2 diabetes mellitus ) |
|
Scientific Title of Study
|
A clinical study of a herbal formulation 'Diabeat' as an adjuvant drug for the control of type 2 diabetes mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Yasmeen Shamsi |
| Designation |
|
| Affiliation |
Dept. of Moalajat, SUMER |
| Address |
Dept. of Moalajat
SUMER, Jamia Hamdard
New DElhi
Jamia Hamdard
New Delhi
DELHI
110062
India |
| Phone |
26059692 |
| Fax |
26059668 |
| Email |
yasmeen.ijum@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Yasmeen Shamsi |
| Designation |
|
| Affiliation |
Dept. of Moalajat SUMER |
| Address |
Dept. of Moalajat
SUMER, Jamia Hamdard
New DElhi
Jamia Hamdard
New Delhi
DELHI
110062
India |
| Phone |
26059692 |
| Fax |
26059668 |
| Email |
yasmeen.ijum@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Yasmeen Shamsi |
| Designation |
|
| Affiliation |
|
| Address |
Dept. of Moalajat
SUMER, Jamia Hamdard
New DElhi
Jamia Hamdard
New Delhi
DELHI
110062
India |
| Phone |
26059692 |
| Fax |
26059668 |
| Email |
yasmeen.ijum@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hamdard National Foundation , New DElhi and Jamia Hamdard, New Delhi |
|
Primary Sponsor
Modification(s)
|
| Name |
Hamdard National Foundation New DElhi |
| Address |
Asaf Ali Road
New Delhi |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Jamia Hamdard, New Delhi |
|
|
Countries of Recruitment
Modification(s)
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Yasmeen Shamsi |
Majeedia Hospital, Jamia Hamdard, New Delhi |
Majeedia Hospital,Jamia Hamdard-110062
New Delhi
DELHI |
01165741409
26059668
yasmeen.ijum@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Hamdard institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diabeat |
2000 mg for 3 months in divided doses |
| Comparator Agent |
Placebo |
2000 mg for 3 months in divided doses |
|
Inclusion Criteria
Modification(s)
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of type-2 diabetes mellitus, age 30-60 years taking Metformin for more than 3 months with uncontrolled hyperglycaemia i.e.HbA1C between 7% to 9% and Body Mass Index (BMI) between 25-29.9 kg/m2.
2. Patients who are able and willing to follow anti-diabetic therapy under a stable life style and diabetic diet.
3.Patients who are willing and able to understand and follow the protocol and provide informed consent.
|
|
| ExclusionCriteria |
| Details |
1.History of treatment with any insulin
2.Diabetes mellitus with complications
3.Pregnant or Lactating women
4.Women of childbearing potential who do not take adequate contraceptive protection.
5.History of hypersensitivity to the Metformin or to drug with similar chemical structure.
6.History of any severe systemic disease.
7.Patients with uncontrolled hypertension.
8.History of drug or alcohol abuse. |
|
Method of Generating Random Sequence
Modification(s)
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Mean HbA1C 6.5% |
12 weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| To achieve a good glycemic control (FPG-80-120 mg/dl; PPG-80-140 mg/dl) |
4,8,12 week |
|
Target Sample Size
Modification(s)
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
23/10/2011 |
| 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
Modification(s)
|
Years="4"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, double blind parallel group, trial comparing the safety and efficacy of 'Diabeat'(1gram twice daily) plus standard drug(Metformin SR-500 mgtwice daily)with placebo (1gram twice daily)plus standard drug(Metformin SR-500mg twice daily)in 100 patients of Type 2 diabetes mellitus that will be conducted in Majeedia Hospital,New Delhi. The primary outcome measures will be To achieve a good glycemic control (FPG-80-120 mg/dl; PPG-80-140 mg/dl,Time point:4,8,12 weeks . The secondary outcome will be Mean HbA1C< 6.5%, Time point: 3 months |