| CTRI Number |
CTRI/2025/03/081843 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| 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
|
Evaluating the Safety and Effectiveness of Unani Herbal and Topical Treatments for Eczema: A Clinical Study |
|
Scientific Title of Study
|
A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Safety and Efficacy of Arq-i-Shahtara and topical Unani Formulation in the Management of Nar Farsi (Eczema) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR WASI AHMAD |
| Designation |
PG SCHOLAR |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
Department of Moalajat (Medicine), National Research Institute of Unani Medicine for Skin Disorders (Formerly Central Research Institute of Unani Medicine)
A.G. Colony Road, ESI Metro Station, Erragadda
Hyderabad
TELANGANA
500038
India |
| Phone |
9560474226 |
| Fax |
|
| Email |
wasiahmad3486@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF DR K MOHAMMED NASAR |
| Designation |
HOD |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
Department of Moalajat (Medicine), National Research Institute of Unani Medicine for Skin Disorders (Formerly Central Research Institute of Unani Medicine)
A.G. Colony Road, ESI Metro Station, Erragadda
Hyderabad
TELANGANA
500038
India |
| Phone |
8328446962 |
| Fax |
|
| Email |
drnasar.nriumsd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR WASI AHMAD |
| Designation |
PG SCHOLAR |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
Department of Moalajat (Medicine), National Research Institute of Unani Medicine for Skin Disorders (Formerly Central Research Institute of Unani Medicine)
A.G. Colony Road, ESI Metro Station, Erragadda
Hyderabad
TELANGANA
500038
India |
| Phone |
9560474226 |
| Fax |
|
| Email |
wasiahmad3486@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Moalajat (Medicine), National Research Institute of Unani Medicine for Skin Disorders (Formerly Central Research Institute of Unani Medicine) Hyderabad. |
|
|
Primary Sponsor
|
| Name |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
8-3-168/A/1/UM, A.G. Colony Road, ESI Metro Station, 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 |
| Dr Wasi Ahmad |
National Research Institute of Unani Medicine for Skin Disorders |
OPD & IPD, Department of Moalajat (Medicine), National Research Institute of Unani Medicine for Skin Disorders (Formerly, Central Research Institute of Unani Medicine), A.G. Colony Road, ESI Metro Station, Erragadda, Hyderabad - 500038
Hyderabad
TELANGANA |
9560474226
wasiahmad3486@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: L309||Dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1. Arq-i-Shahtara (Oral),
2. Topical Unani Formulation (Local) |
1. Arq-i-Shahtara: Dosage Form - Arq(Liquid), Dose - 125ml BD, Mode of Administration - Oral, Composition of Arq-i-Shahtara - Shahtara(Fumaria parviflora Lam.), Aab-e-Taaza(Fresh Water),
2. Topical Unani Formulation: Dosage Form - Tila(Liniment), Dose - Q.S, Mode of Administration - Local(Topical), Composition of Topical Unani Formulation - Cowrie(Kharmohra)(Cypraea moneta L.), kath papad(kaat safed)(Acacia catechu (L.f.)Willd.), Neela thotha(Tootiya)(Verdigris/Copper(II)sulfate(CuSO4)), Haldi(Zard Chob)(Curcuma longa L.), Suhaga(Tankar)(Borax) |
| Comparator Agent |
1. Levocetirizines,
2. 0.05% CLOBETASOL PROPIONATE |
1. Levocetirizines: Dosage Form - Tablets(Solid), Dose - 5mg OD at Night after food, Mode of administration - Oral,
2. Topical 0.05% CLOBETASOL PROPIONATE: Dosage Form - Ointment, Dose - Q.S, Mode of administration - Topical Twice a Day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
The participants will be included in the study on the basis of the following criteria:
1. Participants of any gender between eighteen to sixty-five years of age.
2. Participants having the following any signs and symptoms of disease like Itching, Erythema, Visible flexural eczema, Excoriation, Hyperpigmentation, Burning sensation, Lichenification, Crusting, Dry skin.
3. Participants who are able and willing to comply with the protocol and to sign ICF.
4. Chronicity of more than six months and less than two years. |
|
| ExclusionCriteria |
| Details |
The following patients will be excluded:
1. Participants aged Less than eighteen years and more than sixty-five 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 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 |
| Assessment of Efficacy: Clinical assessment will be done at baseline visit and at each follow-up visit 2nd, 4th and 6th weeks and the assessment of response to treatment will be made on the basis of the change in EASI Score from baseline to the end of treatment, i.e., 6 weeks of therapy. For the efficacy of the test drug, 25% change in appearance and symptomatic relief will be considered significant. |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Photographic Assessment: Digital photography of all lesions will be done using conditions (fixed room, fixed lighting and fixed camera settings) at baseline and 6th week. |
6 weeks |
|
|
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)
|
22/06/2025 |
| 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="8"
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
|
Eczema, known as Nar Farsi in Unani medicine, is a chronic inflammatory skin disorder characterized by severe itching, erythema, scaling, and vesiculation. The prevalence of contact dermatitis in dermatology OPDs is estimated to be 4.38%, with higher rates in urban populations. It is most commonly seen in the 41–50 age group, with females being more affected in urban areas.
Conventional therapies such as glucocorticoids and immunosuppressants provide symptomatic relief but have multiple side effects, including fragile skin, easy bruising, telangiectasis, osteoporosis, hyperglycemia, muscle weakness, delayed wound healing, and increased susceptibility to infections.
The Unani system of medicine has traditionally used single and compound drugs for eczema management, but many of them have not been scientifically evaluated. This Randomized, Parallel Group, Open Label, Active Controlled Clinical Study is designed to assess the safety and efficacy of Arq-i-Shahtara (Fumaria parviflora Lam.) and a Topical Unani Formulation in managing Nar Farsi (Eczema).
Participants meeting the inclusion criteria will be randomly assigned to either the test group (receiving Arq-i-Shahtara and a Unani topical formulation) or the control group (receiving Levocetirizine and 0.05 Clobetasol propionate). The study will evaluate clinical improvements, quality of life, and safety parameters over a 6-week treatment period at NRIUMSD, Hyderabad.
This study aims to provide scientific validation for Unani treatments in eczema management. |