| CTRI Number |
CTRI/2025/12/098691 [Registered on: 09/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to know the effects of a unani formulation in comparison to metformin in the management of type 2 diabetes mellitus. |
|
Scientific Title of Study
|
Assessment of a polyherbal unani formulation in comparison to standard treatment for type 2 diabetes mellitus (ziabetus): A randomized control clinical 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 Md Zahid |
| Designation |
PG Scholar |
| Affiliation |
Government Tibbi College and Hospital Kadam Kuan Patna |
| Address |
PG Department of Moalajat , Room No- 5
Government Tibbi College and Hospital Kadam Kuan Patna
800003
Patna
BIHAR
800003
India |
| Phone |
7903416390 |
| Fax |
|
| Email |
drzahid12345678@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Md Razi Ahmad |
| Designation |
Associate Professor, Moalajat |
| Affiliation |
Government Tibbi College and Hospital Kadam Kuan Patna |
| Address |
PG Department of Moalajat
Government Tibbi College and Hospital Kadam Kuan Patna
800003
Patna
BIHAR
800003
India |
| Phone |
7909045622 |
| Fax |
|
| Email |
dr.razi.ahmed91@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Md Najibur Rahman |
| Designation |
Associate Professor and Head of Department, Moalajat |
| Affiliation |
Government Tibbi College and Hospital Kadam Kuan Patna |
| Address |
PG Department of Moalajat
Government Tibbi College and Hospital Kadam Kuan Patna
800003
Patna
BIHAR
800003
India |
| Phone |
7004484257 |
| Fax |
|
| Email |
drmdnajibur.rahman@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Tibbi College and Hospital Kadam Kuan Patna |
|
|
Primary Sponsor
|
| Name |
Dr Md Zahid |
| Address |
PG Department of Moalajat
Government Tibbi College and Hospital
Kadam Kuan Patna
800003
800003 |
| 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 Md Zahid |
Government Tibbi College and Hospital Patna |
Moalajat OPD No 29
Budh Murti , Kadam Kuan Patna 800003
Patna
BIHAR |
7903416390
drzahid12345678@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Tibbi College and Hospital Patna |
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 |
Glycomet 500 S.R
Recommended dose 1 tablet twice a day after meal for 90 days. |
| Intervention |
PHUF ziabetus powder |
Ingredients of PHUF ziabetus powder are Gurmar booti, Kalonji, Methi, Satte gilo and Maghz Tukhme Jamun in equal proportion.
Recommended dose 5 gram orally twice a day in empty stomach for 90 days . |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjective Parameters are Polyuria, Polydipsia, Tiredness/ Fatigue, weight loss and burning sensation in palms or soles.
Objective Parameters are fasting plasma glucose range 126-150 mg/dl, post prandial plasma glucose range 200- 250 mg/dl and HbA1c range 6.5 to 8 percent. |
|
| ExclusionCriteria |
| Details |
Severe anemia ( Hemoglobin less than 8gram percent in females and hemoglobin less than 10 gram percent in males).
Uncontrolled hypertension and CAD patients.
Any chronic major illness like tuberculosis, CVA, thyroid disease.
Pregnant and lactating women.
Chronic hepatic and renal disorders patients.
Patients having any type of malignancy, autoimmune and immunodeficiency disorders.
Patients with congenital anomaly, mentally retarded and bed ridden. |
|
|
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 |
Reduction in subjective parameters such as polyuria, polydipsia, tiredness and burning palms or soles.
Body weight of the subjects should be constant or increased.
Reduction in fasting plasma glucose and post prandial plasma glucose.
Reduction in HBA1C level. |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
19/12/2025 |
| 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="1"
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
|
This study is an open label, randomized, parallel group, active controlled trial for the evaluation and comparison of PHUF ziabetus powder and metformin in type 2 diabetes mellitus patients in the respect of safety and efficacy. PHUF ziabetus powder will be given orally 5 gram twice a day in empty stomach for 90 days in 30 patients. Control group will be treated with Metformin 500mg . Dose will be one tablet twice a day after meal for 90 days in 30 patients. The study will be conducted in Government Tibbi College and Hospital Kadam Kuan , Patna Bihar. Primary outcomes will be reduction in polyuria, polydipsia, tiredness and burning sensation in palms or soles. Body weight will be constant or increased. There will be also reduction in fasting plasma glucose and post prandial plasma glucose. HbA1c comparison will be done be before and after trial. |