| CTRI Number |
CTRI/2025/12/099418 [Registered on: 18/12/2025] 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, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Unani Medicine for Eczema Treatment |
|
Scientific Title of Study
|
Clinical Efficacy Of Unani Formulations Araq Mundi (Sphaeranthus Indicus) And Raughan Kamela (Mallotus Philipensis) In NarFarsi (Eczema): A Randomized Open Labelled Comparative Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Farzana Anjum A |
| Designation |
P.G Scholar |
| Affiliation |
Government Unani Medical College Chennai |
| Address |
Mactoom sherrif Street, barracks road periamet
Unani Medical College,Arignar Anna Government Hospital Of Indian Campus Arumbakkam Chennai 600106
Chennai
TAMIL NADU
600003
India |
| Phone |
07674918791 |
| Fax |
|
| Email |
mazna.anjum27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mubasheera Begum |
| Designation |
Professor |
| Affiliation |
Government Unani Medical College Chennai |
| Address |
Govt. Unani Medical College, Arignar Anna Government Hospital Of Indian Medicine, Arumbakkam Chennai 600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9841620486 |
| Fax |
|
| Email |
muskaan.m@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Farzana Anjum A |
| Designation |
P.G Scholar |
| Affiliation |
Government Unani Medical College Chennai |
| Address |
Mactoom sherrif Street, barracks road periamet
Unani Medical College,Arignar Anna Government Hospital Of Indian Campus Arumbakkam Chennai 600106
Chennai
TAMIL NADU
600003
India |
| Phone |
07674918791 |
| Fax |
|
| Email |
mazna.anjum27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Arignar Anna Government Hospital Of Indian Medicine Arumbakkam Chennai 600106 |
|
|
Primary Sponsor
|
| Name |
Govt Unani Medical College |
| Address |
Government Unani Medical College 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 Farzana Anjum A |
Arignar Anna Government Hospital of Indian Medicine |
Department Of Moalajat OPD No U1 Arumbakkam Chennai 600106 Tamil Nadu
Chennai
TAMIL NADU |
07674918791
mazna.anjum27@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Araq Mundi(oral)
Raughan Kamela(Topical) |
1 Araq Mundi dosage form Extract,Dose 75ml once daily ,Mode Of Administration oral,Composition of Araq Mundi Gull e Mundi(spheranthus Indicus)and Water2.Raughan :Dosage form :Oil,Dose:Applied Twice Daily,Mode Of Administration:Topical,Composition Of Raughan Kamela:Kamela(Mallotus philipensis)Henna(Lawsonia alba)Neem(Azadarichta indica)Raughan Kunjad (Sesame indicum)sarson Ka Tel (Brassica alba) |
| Comparator Agent |
Clobetasol Propionate 0.05% cream |
Clobetasol Propionate 0.05 % cream for topical application once a day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18 years to 60years
2.Both gender
3.Diagnosis made on the basis of Hannifin and
Rajka criteria
4.Eczema of mild to moderate in severity
5.Participants who have agreed to sign the
informed consent form |
|
| ExclusionCriteria |
| Details |
1.Participants below 18 and above 60 years of age
2.Participants with Autoimmune and other skin diseases
3.Eczema due to secondary infection
4.Pregnant and lactating women
5.Participant not willing to attend treatment schedule regularly |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in EASI Score from baseline |
Baseline
2nd week
4th week
6th week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in DLQI Score from baseline
Improvement in SCORAD from baseline |
Baseline
2nd week
4th week
6th week |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
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)
|
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
|
NarFarsi(Eczema) is an inflammatory condition of skin .The disease manifests as Pruritus, erythema ,edema ,vesicles, scaling and lichenification[1]Eczema is classified into two broad groups .1)Exogenous: where external stimuli trigger development of eczema e.g Irritant dermatitis. 2) Endogenous:where constitutional factors predispose the patient to developing an eczema e.g Atopic dermatitis .According to Unani system of medicine it may be caused by su i mizaj sada and su i mizaj maddi due to abnormal Akhlat involvement , the cause include safra(yelow bile) mixed with sawda(black bile)or Hadd safra (acrid yellow bile )mixed with Dam (sanguine). The treatment modulation of NarFarsi includes ingredients with anti inflammatory ,blood purifying (musaffi e dam) immunomodulatory and skin soothing effects. This integrative approach addresses symptoms and immune balance while aiming to restore skin barrier function. |