| CTRI Number |
CTRI/2025/12/098406 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| 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 On Nar Farsi(Eczema) |
|
Scientific Title of Study
|
A Randomized,Parallel Group,Open Label,Active Controlled Clinical Study To Evaluate The Safety And Efficacy Of A Topical Unani Formulation Compared With Clobetasol Propionate In The Management Of Nar Farsi(Eczema) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ANSARI HINA KAUSAR MOHAMMAD JALIL |
| Designation |
PG SCHOLAR |
| Affiliation |
National Research Institute Of Unani Medicine For Skin Disorders(NRIUMSD) |
| Address |
Department Of Moalajat(Medicine),National Research Institute Of Unani Medicine For Skin Disorders.Opp.ESI Hospital,AG Colony Road,Erragadda,Hyderabad.500038
Hyderabad
TELANGANA
500038
India |
| Phone |
8830051577 |
| Fax |
|
| Email |
hina.kauser2017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ARZEENA JABEEN |
| Designation |
Principal & Professor |
| Affiliation |
National Research Institute Of Unani Medicine For Skin Disorder(NRIUMSD) |
| Address |
National Research Institute Of Unani Medicine For Skin Disorders.
Opp.ESI Hospital,AG Colony Road,Erragadda,Hyderabad.500038
Hyderabad
TELANGANA
500038
India |
| Phone |
9032519286 |
| Fax |
|
| Email |
aarzu763@gmail.cm |
|
Details of Contact Person
Public Query
|
| Name |
DR ANSARI HINA KAUSAR MOHAMMAD JALIL |
| Designation |
PG SCHOLAR |
| Affiliation |
National Research Institute Of Unani Medicine For Skin Disorders(NRIUMSD) |
| Address |
Department Of Moalajat(Medicine),
National Research Institute Of Unani Medicine For Skin Disorders.Hyderabad.
Op ESI Hospital, AG Colony Road, Erragadda, Hyderabad.500038
Hyderabad
TELANGANA
500038
India |
| Phone |
8830051577 |
| Fax |
|
| Email |
hina.kauser2017@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD),Hyderabad.500038 |
|
|
Primary Sponsor
|
| Name |
National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD), Hyderabad |
| Address |
Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad-500038 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| CCRUM |
New Delhi. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ANSARI HINA KAUSAR MOHAMMAD JALIL |
National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD), Hyderabad |
Opd no.4,Opp.ESI Hospital,AG Colony Road,Erragadda,Hyderabad-500038
Hyderabad
TELANGANA |
8830051577
hina.kauser2017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee,NRIUMSD,Hyderabad,Telangana500038 |
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 |
| Comparator Agent |
Clobetasol propionate 0.05% cream |
Clobetasol Propionate 0.05% cream.
Form: Cream for topical application.
Quantity: Cream in sufficient quantity to be applied topically.
Instruction: cream will be applied topically on the affected site twice daily For 8 Weeks. |
| Intervention |
Topical Unani Formulation |
Topical Unani formulation.
.Form:Dimad(Paste)for topical application.
.Quantity: Dimad(Paste)in sufficient quantity to be applied
.Instructions: Dimad(Paste) will be applied topically on the affected site twice daily. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The following participants will be included in the study:
1)Participants of any sex aged between 18 to 60 years
2)Participants having the following symptoms:
Erythema
Scaling
Excoriation
Hyperpigmentation
Burning sensation
Itching
|
|
| ExclusionCriteria |
| Details |
The following participants will be excluded:
1)Participants aged less than 18 years or more than 60 years
2)Participants on concomitant therapy.
3)Known case of Diabetes mellitus.
4)Pregnant or Lactating Women.
5)Significant Pulmonary,Cardiovascular,Hepato-renal Dysfunction.
6)Known cases of Immunocompromised states (HIV,AIDS, etc.),malignancies.
7)Participants not willing to attend treatment schedule regularly. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in EASI Score from baseline to 8 weeks of treatment |
at baseline,2,4,6,8 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Change in CDSQ score from baseline to 8 week.
2)systemic safety assessment. |
1)at baseline,2,4,6,8, week.
2)at baseline and 8 week. |
|
|
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)
|
28/12/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Eczema (Nar Farsi) is a prevalent and distressing skin condition affecting individuals of all ages, with rising global incidence. It significantly impacts quality of life through physical discomfort, psychological stress, and financial burden. Conventional treatments, especially topical corticosteroids, though effective in the short term, pose risks with long-term use and may lead to treatment failure or adverse effects. Dimad, a traditional Unani formulation, is historically used for managing inflammatory skin conditions like eczema. Given the growing need for safer, effective alternatives, this study aims to evaluate the safety and efficacy of Dimad compared to Clobetasol Propionate in managing Nar Farsi (Eczema). |