| CTRI Number |
CTRI/2025/11/097024 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
06/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Safety and Efficacy of Unani Formulation Versus Metformin in Type 2 Diabetes: A Clinical Study |
|
Scientific Title of Study
|
A Randomized, open-label, parallel-group, active controlled clinical study to evaluate the safety and efficacy of a Unani formulation compared with Metformin in patients with Dhayabitus Harr [Type 2 Diabetes Mellitus (G-2)] |
| 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 Mohammad Zakir |
| Designation |
Research Officer (Unani) |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
Room No. 142, Pharmacy section, National Research Institute of Unani Medicine for Skin Disorders, A. G. Colony Road, Near ESI Metro station,
Erragadda, Hyderabad 500038
Hyderabad
TELANGANA
500038
India |
| Phone |
977635513 |
| Fax |
|
| Email |
zakir.rkt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohammad Zakir |
| Designation |
Research Officer (Unani) |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
Room No. 142, Pharmacy Section, National Research Institute of Unani Mediceine for Skin Disorders, A. G. Colony Road, Near ESI Metro station,
Erragadda, Hyderabad 500038
Hyderabad
TELANGANA
500038
India |
| Phone |
977635513 |
| Fax |
|
| Email |
zakir.rkt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohammad Zakir |
| Designation |
Research Officer (Unani) |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
Room No 142, Pharmacy section, National Research Institute of Unani Medicine for Skin Disorders, A. G. Colony Road, Near ESI Metro station,
Erragadda, Hyderabad 500038
Hyderabad
TELANGANA
500038
India |
| Phone |
977635513 |
| Fax |
|
| Email |
zakir.rkt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Unani Medicine (CCRUM),
Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan,
No. 61-65, Institutional Area, Opp. D Block, Janakpuri,
New Delhi - 110058 (India) |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine |
| Address |
61-65 Institution Area, Opposite D Block, Janakpuri New Delhi 110058 |
| Type of Sponsor |
Research institution |
|
|
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 Mohammad Zakir |
National Research Institute of Unani Medicine for Skin Disorders |
Room No. 142, Pharmacy section, National Research Institute of Unani Medicine for Skin Disorders,
A. G. Colony Road, Erragadda, Hyderabad-500038, India
Hyderabad
TELANGANA |
9776355133
zakir.rkt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, NRIUMSD Hyderabad |
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 |
Metformin 500 mg |
Tablet metformin 500 twice daily for 90 days orally |
| Intervention |
Unani formulation |
Unani formulation is a powder drug of natural ingredients. The dose of the powder is 3 gm twice daily orally for 90 days. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases of Type 2 diabetes for at least 6 months prior to screening. HbA1c level equal to or more than 6.5 % at screening. Presence of any of the symptoms and signs of diabetes mellitus as per Unani Literature. Willing and able to provide written informed consent. Willing to comply with the protocol requirements. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in the fasting and postprandial blood glucose
Changes in the HbA1C
from baseline to post-treatment at 90 days. |
Changes in the fasting and postprandial blood glucose
Changes in the HbA1C
from baseline to post-treatment at 90 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
changes in the VAS score for clinical findings.
Changes in the biomarkers. |
Changes in the VAS score at baseline and every 15 days up to 90 days.
Changes in the biomarkers at baseline and at 90 days. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/11/2025 |
| 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="3"
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
|
Study Rationale The Unani System of Medicine focuses on prevention through lifestyle modification dietary management and prophylactic interventions and enhances the immune system to fight against any disease. No specific drug is available for diabetes mellitus instead the drug is used to control the glucose level in the body and manage signs and symptoms of diabetes mellitus. The most commonly used drugs are Oral Hypoglycaemic Drugs (OHD) such as Sulphonylureas (SUs) and Biguanides (BGs). However these drugs have several adverse effects, and long term use of these drugs accumulate adverse effects that may be life threatening and in most cases affect the patient’s quality of life. The Unani drugs are natural and well tolerated by the body and produce fewer side effects than synthetic drugs. Several single and compound formulations are mentioned in the Unani literature which may maintain the body’s blood glucose level and vis-a-vis improve life quality. Therefore Unani formulations with ingredients having hypoglycemic activity may prove beneficial in the effective management of Diabetes mellitus, type 2. |