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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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