| CTRI Number |
CTRI/2025/06/088541 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
06/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Unani Herbal Treatment for High Cholesterol |
|
Scientific Title of Study
|
Clinical Efficacy of Ithrifal Muqil in Management of Dasumath-e-Dam (Dyslipidaemia)-A Non-Randomized Single Arm Clinical Trail |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shaik Amira Afreen |
| Designation |
Final year B.U.M.S student |
| Affiliation |
Government Unani Medical College, Chennai |
| Address |
Department of Moalajat, Academic Block , Government Unani Medical College, ARUMBAKKAM,
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
7708666693 |
| Fax |
|
| Email |
shaikamiraafreen.vnb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMubasheera Begum |
| Designation |
Associate Professor |
| Affiliation |
Government Unani Medical College, Chennai |
| Address |
Department of Moalajat, Government Unani Medical College, ARUMBAKKAM,
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9841620486 |
| Fax |
|
| Email |
muskaan.m@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMubasheera Begum |
| Designation |
Associate Professor |
| Affiliation |
Government Unani Medical College |
| Address |
Department of Moalajat, Government Unani Medical College, ARUMBAKKAM,
Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9841620486 |
| Fax |
|
| Email |
muskaan.m@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Moalajat, Government Unani Medical College, Chennai, TAMIL NADU, CHENNAI-600106 , INDIA |
|
|
Primary Sponsor
|
| Name |
Directorate of Indian Medicine |
| Address |
Directorate of Indian Medicine, Arignar Anna Govt , Hospital for Indian Medicine, Chennai, TAMIL NADU, INDIA PIN
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 MUBASHEERA BEGUM |
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 |
9841620486
muskaan.m@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Unani Medical College Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E785||Hyperlipidemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ithrifal Muqil |
10grams twice a day after food water orally FOR 21 DAYS MINIMUM TO 45 DAYS MAXIMUM. If the symptoms totally subsides, it will be stopped in 21 days, or else it will be continued till 45days. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with abnormal lipid profile, obesity, known case of diabetesand hypothyroidism. |
|
| ExclusionCriteria |
| Details |
Patients below 25 years, above 60 years,
Disease like AIDS , malignancies, pregnancy and lactation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Expecting lipid profile levels return to normal range and improvement in quality of living. |
15 days , 30 days and 45 days after starting therapy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Expecting no immediate adverse effects |
15 days , 30 days and 45 days after starting therapy. |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
04/07/2025 |
| 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="0"
Months="6"
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
|
Ithrifal Muqil, a traditional polyherbal Unani formulation, has been clinically used for over six decades at Arignar Anna Hospital for Indian Medicine to manage Dyslipidaemia (Dasumath-e-Dam), such as obesity, known case of diabetes , and hypothyroidism. Despite its long-standing use in routine care, there is currently no robust scientific evidence to validate its effectiveness, safety, or mechanisms of action.
Purpose of the Trial:
This single-arm clinical study aims to systematically evaluate Ithrifal Muqil’s ability to alleviate lipid profile levels and improve patient well-being. By documenting outcomes in a real-world clinical setting, the trial seeks to bridge the gap between traditional practice and evidence-based medicine, providing data to support its continued use or inform future research. |