| CTRI Number |
CTRI/2026/03/105258 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
29/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of Diabetes Mellitus with Unani Medicine. |
|
Scientific Title of Study
|
A Controlled Clinical Study to Evaluate the Safety and Efficacy of Qurs Tabasheer in the Management 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 |
Dr Khan Asgar Jamal Abdul Mannan |
| Designation |
Research Scholar |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Moalajat, School of Unani Medical Education and Research, Jamia Hamdard, New Delhi
South DELHI 110062 India |
| Phone |
8806500867 |
| Fax |
|
| Email |
drasgarkhan2000@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Azhar Jabin |
| Designation |
Associate Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Moalajat, School of Unani Medical Education and Research, Jamia Hamdard, New Delhi
South DELHI 110062 India |
| Phone |
9899315252 |
| Fax |
|
| Email |
ajabin@jamiahamdard.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Khan Asgar Jamal Abdul Mannan |
| Designation |
Research Scholar |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Moalajat, School of Unani Medical Education and Research, Jamia Hamdard, New Delhi
South DELHI 110062 India |
| Phone |
8806500867 |
| Fax |
|
| Email |
drasgarkhan2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jamia Hamdard (Deemed to be University), Hamdard Nagar, New Delhi, Delhi, India - 110062 |
|
|
Primary Sponsor
|
| Name |
Jamia Hamdard University |
| Address |
Department of Moalajat, School of Unani Medical Education and Research, Jamia Hamdard, Hamdard Nagar, New Delhi, Delhi, India - 110062 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Khan Asgar Jamal Abdul Mannan |
Majeedia Unani Hospital |
Room no. 7, OPD Of Moalajat, Majeedia Unani Hospital, School of Unani Medical Education and Research, Jamia Hamdard, Hamdard Nagar, New Delhi, Delhi, India - 110062 South DELHI |
8806500867
drasgarkhan2000@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 |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Qurs Tabasheer 3 Tabs (2.425g) BD |
Qurs Tabasheer consists of following constituents:
1) Tabasheer (Bambusa arundinacea Willd.)
2) Tukhm-e-Khurfa (Portulaca oleracea Linn.)
3) Tukhm-e-Kahu (Lactuca sativa Linn.)
4) Gul-e-Surkh (Rosa damascena Mill.)
5) Gulnar farsi(Punica granatum Linn.)
6) Gil-e-Armani (Bolus armenicus.)
7) Samagh-e-Arbi (Acacia arabica Willd.)
Qurs Tabasheer 3 Tabs (2.425g) will be given Twice daily orally for 45 days |
| Comparator Agent |
Tab Metformin 500 mg BD |
Tab Metformin 500 mg will be given twice daily orally for 45 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Fasting blood sugar (FBS) must be greater than or equal to 126 mg/dl but less than or equal to 200 mg/dl. OR
2) Postprandial blood sugar (PPBS) must be greater than or equal to 200 mg/dl but less than or equal to 300 mg/dl. OR
3) Glycated hemoglobin (HbA1c) must be greater than or equal to 6.5 % but less than or equal to 8 %.
4) Patients who were able and willing to follow anti-diabetic therapy under stable lifestyle and diabetic diet. |
|
| ExclusionCriteria |
| Details |
1) History of treatment with any medication for glycaemic control (except metformin) within 3 months.
2) History of treatment with systemic corticosteroids within 3 months.
3) Pregnant or lactating women.
4) History of any severe systemic disease.
5) Patients with uncontrolled hypertension.
6) History of drug or Alcohol abuse. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Fasting Blood Sugar and Post-Prandial Blood Sugar |
0th Day and 45th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the improvement in the quality of life of Diabetes mellitus patients. |
At Baseline & 45th Day |
|
|
Target Sample Size
|
Total Sample Size="56" Sample Size from India="56"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
18/03/2026 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Patients diagnosed with diabetes mellitus attending the Outpatient Department of Majeedia Unani Hospital who are willing to participate will be screened according to predefined inclusion and exclusion criteria. Written informed consent will be obtained from each eligible participant prior to enrollment. After enrollment, patients will be randomized into two groups. Group A will receive the polyherbal formulation Qurs Tabasheer at a dose of 4.85 g daily, administered as three tablets twice daily, while Group B will receive Metformin 500 mg twice daily. Baseline demographic details, clinical examination findings, and relevant investigations will be recorded in the Case Report Form. Participants will be followed weekly for assessment of clinical signs and symptoms, with fasting blood sugar measured at each visit and documented in the Case Report Form. At the end of the 45 day treatment period, all baseline investigations including fasting blood sugar, postprandial blood sugar, complete blood count, liver function tests, kidney function tests, serum insulin, and lipid profile will be repeated and recorded in the Case Report Form. The primary outcome will be the change in fasting blood sugar from baseline to day 45, while secondary outcomes will include changes in postprandial blood sugar, serum insulin, lipid profile, and clinical symptom scores. |