| CTRI Number |
CTRI/2025/11/096759 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| 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
|
Comparison of sweet almond oil and urea cream for treating chronic atopic dermatitis (nar farsi muzmin) |
|
Scientific Title of Study
|
Comparative efficacy of Roghan Badam Shirin and 10% urea cream in the management of Nar Farsi Muzmin (chronic atopic dermatitis) A randomized controlled 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 |
Tanjim Aalam |
| Designation |
Post graduate Scholar |
| Affiliation |
State Unani Medical College and HAHRDM Hospital Himatganj Prayagraj Uttar Pradesh |
| Address |
Department of Amraze Jild wa Tazeeniyat
State Unani Medical College and HAHRDM Hospital
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
8887706429 |
| Fax |
|
| Email |
tanjimaalam94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mohd Khalid |
| Designation |
Guide |
| Affiliation |
STATE UANANI MEDICAL COLLEGE AND HAHRDM HOSPITAL HIMMATGANJ PRAYAGRAJ UTTAR PRADESH |
| Address |
Department of Amraze Jild wa Tazeeniyat
State Unani Medical College Himmatganj Prayagraj State Bank of India ATM Old Grand Trunk Road Himmatganj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
9916261251 |
| Fax |
|
| Email |
khalidhameedkhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
TANJIM AALAM |
| Designation |
PG SCHOLAR |
| Affiliation |
STATE UANANI MEDICAL COLLEGE AND HAHRDM HOSPITAL HIMMATGANJ PRAYAGRAJ UTTAR PRADESH |
| Address |
Department of Amraze Jild wa Tazeeniyat State Unani Medical College and HAHRDM Hospital Himatganj Prayagraj Uttar Pradesh
211001
India
Boys Hostel Room No. 10 State Unani Medical College Himmatganj Prayagraj State Bank of India ATM,Grand Trunk Road Himmatganj Prayagraj Uttar Pradesh
211003
Allahabad
UTTAR PRADESH
211001
India |
| Phone |
8887706429 |
| Fax |
|
| Email |
tanjimaalam94@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Unani Medical College and Hospital Prayagraj UP India |
|
|
Primary Sponsor
|
| Name |
State Unani Medical College and HAHRDM Hospital Prayagraj |
| Address |
Department of Amraze Jild wa Tazineeyat State Unani Medical College and HAHRDM Hospital Prayagraj |
| 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 Mohd Khalid |
Room No. 3 |
State Unani Medical College and Hospital Himmatganj Prayagraj
Allahabad
UTTAR PRADESH |
9916261251
khalidhameedkhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical Research State Unani Medical College and HAHRDM Hospital Prayagraj. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L208||Other atopic dermatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Roghan Badam Shirin oil |
oil to be applied in adequate quantity on the lesions twice a day for 42 days |
| Comparator Agent |
Urea ten percent |
Urea to be applied topically twice a day in adequate quantity for 42 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 18 and 65 years of age Diagnosed cases of Chronic Atopic Dermatitis as per Hannifin and Rajika criteria
Patients who will give consent and able to do followup
|
|
| ExclusionCriteria |
| Details |
Patients below 18 and above 65 years of age
Pregnant and lactating women
Patients having secondary infection and concomitant skin diseases
Patients suffering from systemic illnesses like diabetes, malignancy
Patients of acute Chronic Atopic Dermatitis of 2 weeks with vesicles and oozing, Stasis Dermatitis, Psoriasis and Exfoliative Dermatitis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in pruritus to be assessed on visual analoge scale |
7, 14, 28 and 42th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary Outcome: change in EASI, ISGA and & Photography to be assessed baseline. |
7th, 14th, 28th and 42nd day. |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/11/2025 |
| Date of Study Completion (India) |
22/08/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [khalidhameedkhan@gmail.com].
- For how long will this data be available start date provided 25-09-2025 and end date provided 24-09-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
It is randomized open labelled parallel arm standard controlled clinical study for the duration of 18 months. The protocol duration is 42 days. Participants attending the outpatient department and inpatient department of State Unani Medical College and Hospital, Prayagraj, will be evaluated for the presence of Nar Farsi Muzmin, Clinical and lab indicators will be evaluated for the participants. They will be included in the study if they meet the inclusion criteria. Purpose and goals of the study, as well as the specifics of the other study related procedures will be explained to them. Before enrolling them, the participants will be asked to sign an informed consent form. To document the numerous signs and symptoms of Jarab, a thorough physical and biochemical examination will be performed, and blood will be drawn. The study drug will be administered as scheduled, and participants will be given instructions on how to use the medication. |