| CTRI Number |
CTRI/2023/03/050218 [Registered on: 01/03/2023] Trial Registered Prospectively |
| Last Modified On: |
28/02/2023 |
| 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
|
Study to evaluate the Efficacy and Safety of a topical Unani Formulation in the Management of Eczema |
|
Scientific Title of Study
|
A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Efficacy and Safety of a topical Unani Formulation in the Management of NÄr FÄrsÄ« (Eczema) |
| Trial Acronym |
CSUNF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mariyam Muzaffer |
| Designation |
M.D Scholar |
| Affiliation |
National Research Institute of Unani Medicine For Skin Disorders |
| Address |
Department Of Moalajat, National Research Institute of Unani
Medicine for Skin Disorders, A G Colony Road, Opposite ESI
Hospital, Erragadda,
Hyderabad
TELANGANA
500038
India |
| Phone |
8121309405 |
| Fax |
|
| Email |
mariyam.fatima76@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Qamar Uddin |
| Designation |
Proffesor & HOD |
| Affiliation |
National Research Institute of Unani Medicine For Skin Disorders |
| Address |
Department Of Moalajat, National Research Institute of Unani
Medicine for Skin Disorders, A G Colony Road, Opposite ESI
Hospital, Erragadda,
Hyderabad
TELANGANA
500038
India |
| Phone |
8700027178 |
| Fax |
|
| Email |
ccrumhqrsnd58@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mariyam Muzaffer |
| Designation |
M.D Scholar |
| Affiliation |
National Research Institute of Unani Medicine For Skin Disorders |
| Address |
Department Of Moalajat, National Research Institute of Unani
Medicine for Skin Disorders, A G Colony Road, Opposite ESI
Hospital, Erragadda,
Hyderabad
TELANGANA
500038
India |
| Phone |
8121309405 |
| Fax |
|
| Email |
mariyam.fatima76@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Research Institute of Unani Medicine For Skin Disorders |
|
|
Primary Sponsor
|
| Name |
National Research Institute of Unani Medicine For Skin Disorders |
| Address |
A G Colony Road, Opposite ESI Hospital, Erragadda, Hyderabad
500038
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Mariyam Muzaffer |
National Research Institute of Unani Medicine for Skin Disorders |
OPD of Department of Moalajat, National Research Institute of Unani Medicine for Skin Disorders AG Colony Rd,opp ESI Hospital Erragadda,500038
Hyderabad
TELANGANA |
8121309405
mariyam.fatima76@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, NRIUMSD, Hyderabad |
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 |
0.1% Mometasone furoate |
In sufficient quantity to be applied topically on the affected site once daily for the period of 42 days |
| Intervention |
Habb-e-Akuta |
In sufficient quantity to be crushed and mixed with equal quantity of Pure Ghee to make Tila (liniment) and applied topically on the affected site once daily for the period of 42 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants having the following signs and symptoms of disease: Itching, History of Asthma / hay fever in 1st degree relatives, Visible flexural eczema, Excoriation, Burning sensation, Lichenification, Crusting, Dry skin.
2. Participants who are able and willing to comply with the protocol and to sign ICF
3. Chronicity of more than 6 months and less than 2 years |
|
| ExclusionCriteria |
| Details |
1.Participants aged Less than 18 years and more than 65 years
2. Known cases of significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction, Malignancy, HIV infection, AIDS, etc.
3. Any other clinical condition that in the opinion of the investigator would compromise the patient’s safety or successful participation in the trial.
4. Pregnancy and Lactation
5. Known allergy, sensitivity or intolerance to the study drug or any of its ingredients
6. Participants with active alcohol intake and/or drug abuse
7. Participants not willing to sign the ICF and 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 |
| 25% change in appearance and symptomatic relief will be considered significant |
42 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Digital photography of all lesions will be done using conditions (fixed room, fixed lighting and fixed camera settings ) |
42 days |
|
|
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 |
|
Date of First Enrollment (India)
|
05/03/2023 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
NÄr FÄrsÄ« (Eczema) is a chronic skin disease, with high incidence, and recurrence. Moreover, topical steroids used in the management of eczema impair barrier functions and exhibit the adverse effects, such as skin atrophy, pituitary adrenal axis suppression, and masked infections, and steroid withdrawal can lead to sudden and severe rebound aggression, thinning of skin with striae, bruising, delayed wound healing, depigmentation, etc. Thus, there is no promising cure for eczema; hence the present clinical study has been designed to evaluate the Safety and Efficacy of a topical Unani Formulation Habb-e- Akuta in the management of eczema. |