| CTRI Number |
CTRI/2025/10/096318 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Unani Medicines vs Standard Treatment for Blood Sugar Control in Type 2 Diabetes |
|
Scientific Title of Study
|
A Hybrid Dose-Escalation Randomized Controlled Trial Comparing Unani Drugs and Standard Treatment for Glycemic Control in 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 Nazim Husain |
| Designation |
Research Officer Unani |
| Affiliation |
Regional Research Institute of Unani Medicine, Silchar |
| Address |
RRIUM, Vaterinary Bazar, Ghungoor, Cachar-788014, Silchar
Cachar
ASSAM
788014
India |
| Phone |
9212143572 |
| Fax |
|
| Email |
nazim.ccrum@ccrum.res.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Younis Iftikhar Munshi |
| Designation |
Deputy Director and Head |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
NRIUMSD, Opp. ESI Metro Station, A.G. Colony Road, Erragadda, Hyderabad
Hyderabad
TELANGANA
500038
India |
| Phone |
9419086700 |
| Fax |
|
| Email |
munshi.younis@gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nazim Husain |
| Designation |
Research Officer Unani |
| Affiliation |
Regional Research Institute of Unani Medicine, Silchar |
| Address |
RRIUM, Vaterinary Bazar, Ghungoor, Cachar-788014, Silchar
Cachar
ASSAM
788014
India |
| Phone |
9212143572 |
| Fax |
|
| Email |
nazim.ccrum@ccrum.res.in |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Unani Medicine, Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan
No.61 to 65, Institutional Area, Opp. D Block, Janakpuri,
New Delhi, 110058, India |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM New Delhi |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan No.61 to 65, Institutional Area, Opp. D Block, Janakpuri, New Delhi, 110058, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Regional Research Institute of Unani Medicine Silchar |
Veterinary Bazar Road, Ghnugoor, Silchar, Cachar, 788014, Assam, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nazim Husain |
Regional Research Institute of Unani Medicine, Silchar |
Room No. 106, Ground Floor, RRIUM, Veterinary Bazar Road, Ghungoor, Silchar, Cachar, 788014, Assam, India
Cachar
ASSAM |
9212143572
nazim.ccrum@ccrum.res.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee RRIUM Silchar |
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 hydrochloride and Glimepiride |
1. Metformin hydrochloride:
o Dosage: Participants will start with 500 mg BID or 1000 mg once daily, with the dose potentially escalated to 1000 mg BID at Week 2, depending on the patients response.
2. Glimepiride:
o Dosage: Glimepiride will be introduced at 1 mg once daily if glycemic control is not achieved by Week 4 with metformin alone. The dose will be titrated in 1 mg increments every 2 weeks, up to a maximum of 4 mg daily.
|
| Intervention |
Qurs-e-Ziabetus Khaas and Qurs-e-Kafoor |
1. Qurs-e-Ziabetus Khaas:
o Dosage: The initial dosage will be 1g twice daily (BID). Based on the patients glycemic response, the dose may be escalated to 2g twice daily at Week 2, if necessary.
2. Qurs-e-Kafoor:
o Dosage: The drug will be introduced at 2g twice daily (BD) if glycemic targets are not met at Week 4 with Qurs-e-Ziabetus Khaas alone. The dose will be titrated in 1 g increments every 2 weeks, up to a maximum of 8 g daily.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosis of Type 2 Diabetes Mellitus (T2DM): Patients with a confirmed diagnosis of T2DM based on American Diabetes Association (ADA) or World Health Organization criteria. Diagnostic criteria include: HbA1c more than or equal to 6.5, or fasting plasma glucose, more than or equal to 126 mg per dL (7.0 mmol per L), or 2 hour plasma glucose more than or equal to200 mg per dL (11.1 mmol per L) during an Oral Glucose Tolerance Test.
2. HbA1c more than 6.5 to less than or equal to 9 or blood glucose more than or equal to 126 mg per dL (7.0 mmol per L) to less than or equal to 300 mg per dL (less than or equal to 16.7 mmol per L), indicating suboptimal glycemic control, and a need for additional therapeutic intervention.
3. Adults aged 18 to 65 years.
4. Body Mass Index from 18.5 to 35 kg per meter square.
5. Already diagnosed patients with T2DM for up to 10 years.
6. Patients who have not been taking any antidiabetic medication for at least 2 weeks before enrollment.
|
|
| ExclusionCriteria |
| Details |
1. Type 1 Diabetes Mellitus or other specific forms of diabetes (e.g., MODY, secondary diabetes).
2. Severe Diabetes Complications: Advanced diabetic neuropathy, nephropathy, or retinopathy. History of recent cardiovascular events, such as myocardial infarction or stroke within the past 6 months. Active or unstable diabetic foot ulcers or severe peripheral vascular disease.
3. Patients currently on insulin therapy.
4. Significant liver disease, renal insufficiency (e.g., estimated glomerular filtration rate less than 30 mL per min per 1.73 meter square), or heart failure (NYHA class III to IV).
5. Pregnant or lactating women.
6. Conditions such as peptic ulcer disease or severe gastrointestinal disorders that may interfere with treatment.
7. Known allergies or intolerance to metformin, glimepiride, or other study related medications.
8. Patients who are actively taking treatment for T2DM.
|
|
|
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 |
| Change in HbA1c: The primary measure of efficacy will be the change in HbA1c levels from baseline to Week 24. HbA1c is a key indicator of long-term glycemic control and will be used to assess the overall effectiveness of the treatments in reducing blood glucose levels. |
HbA1c will be measured at baseline, Week 12, and Week 24 to track changes in glycemic control over time. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in Fasting Plasma Glucose (FPG)
2. Time to Achieve Glycemic Targets
3. Change in Body Mass Index (BMI)
4. Change in Lipid Profile:
5. Change in Clinical Symptoms: The severity of classical symptoms, including polydipsia, polyuria, polyphagia, fatigue, and sleep disturbances, will be assessed using a 5-point Likert scale to evaluate the treatment impact on clinical symptoms.
6. Treatment Satisfaction and Well-being: Patient satisfaction with the treatment and overall well-being will be measured using a 10-point Visual Analog Scale (VAS).
|
-Change in Fasting Plasma Glucose (FPG)
Time Points: FPG will be assessed at baseline and at every follow-up visit (every 2 weeks).
-Time to Achieve Glycemic Targets
Time Points: This will be tracked at each follow-up visit.
-Change in Body Mass Index (BMI)
Time Points- Body weight will be measured at baseline, Week 12, and Week 24.
-Change in Lipid Profile:
Time Points- Lipid profile will be assessed at baseline, Week 12, and Week 24.
-Change in Clinical Symptoms: The severity of classical symptoms, including polydipsia, polyuria, polyphagia, fatigue, and sleep disturbances, will be assessed using a 5-point Likert scale to evaluate the treatment impact on clinical symptoms.
Time Points- Body weight will be measured at baseline, Week 12, and Week 24.
-Treatment Satisfaction and Well-being: Patient satisfaction with the treatment and overall well-being will be measured using a 10-point Visual Analog Scale (VAS).
Time Points- Body weight will be measured at baseline, Week 12, and Week 24.
|
|
|
Target Sample Size
|
Total Sample Size="152"
Sample Size from India="152"
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)
|
04/10/2027 |
| 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="2"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nazim.ccrum@ccrum.res.in].
- For how long will this data be available start date provided 04-10-2027 and end date provided 04-10-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - www.ccrum.res.in
|
|
Brief Summary
|
Background: Type 2 Diabetes Mellitus (T2DM) is a significant health issue, particularly in India. Standard treatments like metformin and glimepiride are effective but often lead to side effects. Unani formulations, such as Qurs-e-Ziabetus Khaas and Qurs-e-Kafoor, offer a potential alternative due to their hypoglycemic properties Aim: This study aims to evaluate the efficacy and safety of Unani drugs compared to standard treatments, with the goal of integrating Unani medicine into mainstream diabetes care. Objective: To compare the efficacy of Unani formulations with standard treatments in controlling blood sugar levels, measured by HbA1c, assess safety, and patient outcomes over a 24-week period. Methodology: The study is a randomized, controlled clinical trial involving 200 participants with T2DM, randomly assigned to either the Unani treatment group or the standard treatment group. Block randomization with a block size of four will ensure balanced group assignments. Participants in the Unani group will receive Qurs-e-Ziabetus and Qurs-e-Kafoor, while the control group will receive metformin and glimepiride. Both groups will follow standardized diet and exercise plans. The study will follow participants for 24 weeks, with regular follow-up visits every two weeks with dose escalation as per protocol. Inclusion criteria include patients aged 18-65 with HbA1c levels between 7% and 10%, while exclusion criteria involve insulin dependence, severe comorbidities, and pregnancy. Results: The primary outcome is the change in HbA1c levels measured at baseline, Week 12 and Week 24, providing a direct measure of glycemic control. Secondary outcomes include changes in fasting plasma glucose, lipid profiles, body weight, and patient-reported outcomes including treatment satisfaction and overall wellbeing. Safety assessments, including liver and kidney function tests, will be conducted to monitor adverse events. Expected Benefits: This study aims to provide robust evidence on the efficacy and safety of Unani formulations in managing T2DM. If successful, the findings could support the inclusion of Unani treatments in national health programs as an alternative for diabetes management. The potential to improve health outcomes could significantly benefit both patients and healthcare systems. |