| CTRI Number |
CTRI/2026/02/104932 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/08/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to test the effect of Safuf-i-Dhayabitus on lowering blood sugar in people with Type 2 diabetes |
|
Scientific Title of Study
|
A Prospective, Randomized Controlled Comparative Study to Evaluate the Efficacy and Safety of Safuf-i-Dhayabitus in Patients with 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 RC Satish Kumar |
| Designation |
Professor and Coordinator |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
No. 18, 4th floor Clinical Trial and Research Unit, SRM Medical College Hospital and Research Centre Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884845887 |
| Fax |
|
| Email |
dean.iiism@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mothishwaran B |
| Designation |
Clinical Research Manager |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
No. 13, 4th floor Clinical Trial and Research Unit, SRM Medical College Hospital and Research Centre Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8825580604 |
| Fax |
|
| Email |
mothishb@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mothishwaran B |
| Designation |
Clinical Research Manager |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
No. 13, 4th floor Clinical Trial and Research Unit, SRM Medical College Hospital and Research Centre Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8825580604 |
| Fax |
|
| Email |
mothishb@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Unani Medicine (CCRUM), MINISTRY OF AYUSH, AYUSH BHAWAN, B Block, GPO Complex, INA, NEW DELHI - 110023. |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Central Council for Research in Unani Medicine (CCRUM), MINISTRY OF AYUSH, AYUSH BHAWAN, B Block, GPO Complex, INA, NEW DELHI - 110023. |
| Type of Sponsor |
Government funding agency |
|
|
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 RC SATISH KUMAR |
SRM Medical College Hospital and Research centre |
4th floor, B block, Room no.18, Metabolic ward, SRM Nagar, Kattankulathur
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU |
8825580604
dean.iiism@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM INSTITUTIONAL ETHICS 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. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Safuf-i-Dhayabitus, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 180 Days, anupAna/sahapAna: Yes(details: -anupAna), Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | Metformin | Metformin Tablet – 500mg BID after food for 180 days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Male or female patients within the age range of 30 and 65 years of age diagnosed with T2DM for at least 6 months.
Participants with fasting plasma glucose greater than or equal to 126 mg/dL or random plasma glucose greater than 200 mg/dL.
Participants with an HbA1c value of 6.5–8 percent.
Willingness to provide written informed consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Type 1 Diabetes Mellitus
HbA1c greater than eight percent.
Severe renal, hepatic, cardiac, gastrointestinal, neurological, hematological, or respiratory disorders, in the view of the investigator.
Patients with psychiatric disorder.
History of smoking more than ten cigarettes per day or alcohol intake greater than twenty grams per day.
History or evidence suggestive of complications of diabetes such as retinopathy, nephropathy, or ischemic heart disease with any cardiac event in the last six months.
Body mass index greater than thirty five kilograms per square meter or less than twenty kilograms per square meter.
Patients who are likely to undergo surgery during the study period.
Patients who have participated in any investigational study in the last twelve weeks.
Known hypersensitivity to the study drugs.
Patients with severe infection, in the view of the investigator.
History of intake of any Ayurvedic, herbal, homeopathic, or dietary supplements in the last two months.
Pregnant or nursing mothers and women of childbearing age refusing to use contraceptives. |
|
|
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 |
To measure the reduction of blood sugar levels.
To measure the reduction of HbA1c levels.
To Compare the severity assessment between two groups.
|
To measure the reduction of blood sugar levels from baseline (Day 0) till the end of the study (Day 180).
To measure the reduction of HbA1c levels from baseline (Day 0) till the end of the study (Day 180).
To Compare the severity assessment between two groups from baseline (Day 0) till the end of the study (Day 180).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the change in safety parameters.
To assess the safety and tolerability of the drug.
|
To assess the change in safety parameters from baseline (Day 0) till the end of the study (Day 180).
To assess the safety and tolerability of the drug from baseline (Day 0) till the end of the study (Day 180).
|
|
|
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)
|
12/03/2026 |
| 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
|
This is a prospective, randomized, open-label, controlled, comparative clinical study designed to evaluate the efficacy and safety of Safuf-i-Dhayabitus, a Unani herbal formulation, in patients with Type 2 Diabetes Mellitus (T2DM). The study will be conducted at SRM Medical College Hospital and Research Centre over a 6-month period. A total of 100 T2DM patients (aged 30–65 years) will be enrolled and randomized in a 1:1 ratio into two groups: The primary outcomes include reduction in blood glucose levels (FBS, PPBS) and HbA1c from baseline to study end, along with comparative severity assessment between groups. Secondary outcomes focus on safety evaluation through laboratory parameters and monitoring of adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs). Patients will be assessed at baseline, Day 45, Day 90, Day 135, and Day 180, with regular monitoring of glycemic parameters, vitals, systemic examinations, and safety labs. Randomization will be computer-generated, and the study will adhere to ICH-GCP guidelines and the Declaration of Helsinki. |