| CTRI Number |
CTRI/2025/12/099559 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of a Unani Herbal Medicine Chilbeenj on Blood Sugar Control in Patients with Type 2 Diabetes. |
|
Scientific Title of Study
|
Clinical Efficacy Of Chilbeenj (Strychnos Potatorum) In The Management Of Dhayabitus Sukkari (Type 2 Diabetes Mellitus): A Randomized Controlled Trial |
| 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 DUA HARMAIN A S |
| Designation |
PG scholar |
| Affiliation |
Government Unani Medical College |
| Address |
Department of Moalajat, Academic Block II, Government Unani
Medical College, ARUMBAKKAM,
Chennai
TAMIL NADU
600106
India |
| Phone |
9940929889 |
| Fax |
|
| Email |
duaharmain76@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MUBASHEERA BEGUM |
| Designation |
Professor |
| Affiliation |
Government Unani Medical College |
| Address |
Department of Moalajat, Academic Block II, Government
Unani Medical College,
Chennai
TAMIL NADU
600106
India |
| Phone |
9841620486 |
| Fax |
|
| Email |
muskaan.m@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MUBASHEERA BEGUM |
| Designation |
Professor |
| Affiliation |
Government Unani Medical College |
| Address |
Department of Moalajat, Academic Block II, Government
Unani Medical College,
Chennai
TAMIL NADU
600106
India |
| Phone |
9841620486 |
| Fax |
|
| Email |
muskaan.m@gmail.com |
|
|
Source of Monetary or Material Support
|
| State government, Govt of TamilNadu, Government Unani Medical College, Arumbakkam, Chennai 600106 |
|
|
Primary Sponsor
|
| Name |
Government of TamilNadu |
| Address |
Government Unani Medical College, ARUMBAKKAM, CHENNAI-600106 |
| Type of Sponsor |
Government medical college |
|
|
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 DUA HARMAIN A S |
Arignar Anna Government Hospital of Indian Medicine |
Department of
Moalajat(Unani
General Medicine),
OP NO 5, A.A.G.H.I.M
Campus, Near Anna
Arch,Arumbakkam
Chennai
TAMIL NADU |
09940929889
duaharmain76@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethics Committee (IEC) for Unani Medical Research for PG Scholars of M.D.(Unani) |
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 |
| Intervention |
Chilbeenj/Nirmali (strychnos potatorum) |
Group A:powdered chilbeenj in capsules 500mg twice a day after food for 4 weeks |
| Comparator Agent |
Metformin 500mg |
Group B: Tab: Metformin 500mg Dosage: 1 TAB Twice a day (1-0-1) for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 30 years to 60 years
2. Both Genders
3. Recently Diagnosed Cases of Type 2 DM up to 3 years
4. Fasting Blood Sugar (FBS) Less than or equal to 126mg/dl Up to 200mg/dl
5.2hr Plasma Glucose (2PG) less than or equal to 200 mg/dl Up to 300 mg /dl
6.HbA1C more than 6.5 up to 9
7. Participants willing to participate in this study
8. Patients taking less than or equal to 2 hypoglycaemic drugs will be included in the study
|
|
| ExclusionCriteria |
| Details |
1. History of allergy or intolerance to any drug,
2. Type 1 diabetes,
3. Fasting blood sugar (FBS) more than 200mg/dl,
4. 2-hr Plasma Glucose (2PG) more than 300mg/dl,
5.HbA1C more than 10,
6. Diabetic patients with serious acute and chronic complications, such as diabetic ketoacidosis, Known cases of type 2 diabetes mellitus requiring insulin treatment
7. Pregnant or lactating women,
8. Patients who are on medication more than 3 hypoglycemic drugs,
9. History of Patients with known systemic illnesses such as chronic kidney disease, liver disorders, cardiovascular disease, or autoimmune conditions will be excluded.
10. Alcoholics, smokers, and drug addicts.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in FBS and 2-hr PPBS |
4 weeks : 0 (baseline), 2 weeks, 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. changes in oxidative stress markers PC – Protein Carbonyl(27), FRAP – Ferric Reducing Antioxidant Power(28).
2. Improvement in ADQOL (Asian Diabetes Quality of Life)
3. HbA1c level
|
0 (baseline), and 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
02/01/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| 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
|
NEED OF THE STUDY Type 2 Diabetes Mellitus (T2DM) is rising rapidly in India(3), with increasing prevalence even in rural areas and among younger populations. Despite the availability of many treatments, long-term use often leads to adverse effects, high costs, and limited efficacy in managing glycemic levels. Given the classical Unani perspective on diabetes and the emerging evidence of Strychnos potatorum (Chilbeenj/Nirmali) exhibiting hypoglycemic and antioxidant properties as per preclinical studies, there is a compelling need to scientifically validate its efficacy. This study aims to bridge traditional Unani knowledge with modern pharmacological evaluation to explore a safer, effective, and alternative approach for managing T2DM. |