| CTRI Number |
CTRI/2025/09/094234 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Feasibility Study Comparing a Unani Regimen and Metformin in the management of Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
A Feasibility Study Comparing a Unani Regimen and Metformin 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 Arjumand |
| Designation |
Research Officer(Unani) |
| Affiliation |
Regional Research Institute of Unani Medicine Naseem Bagh |
| Address |
Habbak
Habbak Srinagar
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006180746 |
| Fax |
|
| Email |
dr.arjumandshah111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arjumand |
| Designation |
Research Officer(Unani) |
| Affiliation |
Regional Research Institute of Unani Medicine Naseem Bagh |
| Address |
Habbak
Habbak Srinagar
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006180746 |
| Fax |
|
| Email |
dr.arjumandshah111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arjumand |
| Designation |
Research Officer(Unani) |
| Affiliation |
Regional Research Institute of Unani Medicine Naseem Bagh |
| Address |
Habbak
Habbak Srinagar
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006180746 |
| Fax |
|
| Email |
dr.arjumandshah111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Regional Research Institute of Unani Medicine, Srinagar |
|
|
Primary Sponsor
|
| Name |
Regional Research Institute of Unani Medicine, Srinagar |
| Address |
Naseem Bagh, Habak University of Kashmir
pin190006 |
| 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 Arjumand |
Regional Research Institute of Unani Medicine |
Naseem Bagh Habak University of Kashmir
Srinagar 190006
Srinagar
JAMMU & KASHMIR |
07006180746
dr.arjumandshah111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 500mg |
one Tablet after meals once daily for 3 months |
| Intervention |
Qurs-e-Ziabetes ,Arq Mako,Arq Kasni |
Qurs Ziabetes is a tablet form of the drug will be given in dose of 3 tablets (750mg) thrice daily for 3 months
Arq Mako and Arq Kasni are Distillates used as mixture in dosage of 50ml each twice daily for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age greater than or equal to18 and less than or equal to 65 years
2. Not pre-treated with any ant diabetic agents within 2 months
3. Fasting Plasma Glucose Level between126 and 150 mg per dl
4. 2h plasma glucose between 200 mg per dl and 250 mg per dl
5. Random plasma glucose between 200 mg per dl and 250 mg per dl
6. HbA1c greater than or equal to 6.5percent
7. Body weight greater than 50 kg
8. Willingness to abstain from alcohol, tobacco, and any caffeine containing drinks during treatment periods
9. Ability to understand sign informed consent and comply with study protocol
|
|
| ExclusionCriteria |
| Details |
1. Pregnant and breastfeeding women,
2. Patients with Fasting Plasma Glucose level greater than or equal to 150mg per dl.
3. Patients with Post Prandial Plasma Glucose level greater than or equal to 150mg per dl
4. Significant pulmonary gastrointestinal cardiovascular hepatic-renal dysfunction. Diabetes Mellitus Type I or Diabetes Insipidus or Patient on Insulin Therapy HIV HCV HBSAG Cancer cardiovascular diseases autoimmune disorders
5. Evidence or a history of diabetes complications for example diabetic retinopathy neuropathy acute hyperglycaemic emergency and diabetic foot)
6. Any Seasonal illness lasting more than 10 days
7. Tobacco greater than or equal to 10 cigarettes per day within 3 months prior to screening or drug abuse
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in Fasting Blood Sugar
Change in Postprandial Blood Sugar PPBS
Change in HbA1c levels.
|
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Body weight and BMI
Lipid profile Total cholesterol LDL HDL Triglycerides.
Liver and kidney function tests to assess safety
Patient reported outcomes like fatigue thirst polyuria etc
|
90 days |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
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)
|
01/10/2027 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Diabetes is a chronic diseases characterized by elevated blood glucose concentration and the eighth leading cause of death and disability in the world. Use of unani medicine is quite popular in diabetes. Clinical experience has indicated that when QZK is administered in combination with Arq Maqo and Arq Kasni, the therapeutic outcomes appear significantly enhanced. This synergistic combination not only contributes to better glycemic control but may also positively influence related metabolic parameters—an essential aspect of holistic diabetes management in the Unani system. This pilot feasibility study is designed to evaluate the practicability, safety, and preliminary glycaemic efficacy of the QZK–Arq Maqo–Arq Kasni regimen in comparison with standard Metformin therapy in patients with Type 2 Diabetes Mellitus (T2DM).A total of 7 adult patients diagnosed with T2DM will be enrolled and randomly assigned to two groups: Group A: Standard therapy with Metformin Group B: Unani regimen comprising QZK along with Arq Maqo and Arq Kasni, selected based on classical Unani literature and clinical practice. The primary aim is to assess the feasibility of conducting a larger randomized controlled trial by evaluating recruitment and retention rates, patient adherence, safety/tolerability of interventions, and initial clinical outcomes. Preliminary changes in Fasting Blood Sugar (FBS), Postprandial Blood Sugar (PPBS), and HbA1c will be measured over a defined treatment period. Additionally, patients will be monitored for adverse effects and symptomatic improvement, providing early insight into the safety and potential efficacy of the Unani regimen. The outcomes of this pilot study will help optimize methodology, refine dosage protocols, and guide the design of future large-scale studies exploring integrative approaches to diabetes management using Unani medicine. |