| CTRI Number |
CTRI/2025/03/081624 [Registered on: 04/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Dandruff treatment with unani formulation |
|
Scientific Title of Study
|
Therapeutic evaluation of a topical unani formulation in the treatment of Hazaz (Pityriasis capitis): A randomizes open label pilot controlled trial. |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mansoori Aliya Fatima |
| Designation |
UG Student |
| Affiliation |
Luqman Unani Medical College Hospital and Research Centre |
| Address |
Ground Floor Roomno 1,General OPD,Department of Moalajat Luqman Unani Medical College Hospital and Research Centre 12 Naubag Vijayapur
Bijapur
KARNATAKA
586101
India |
| Phone |
8591300313 |
| Fax |
|
| Email |
mansoorialiya769@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Juveriya Naaz Bhusnur |
| Designation |
Assistant Professor Department of Amraze niswan wa qabalat |
| Affiliation |
Luqman Unani Medical College Hospital and Research Centre |
| Address |
2nd Floor Room number 2 Department of Amraz e niswan wa qabalat Luqman Unani Medical College Hospital and Research Centre 12 Naubag Vijayapura Karnataka
Bijapur
KARNATAKA
586101
India |
| Phone |
7406810517 |
| Fax |
|
| Email |
drjuveriya10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shaikh Nisar Ahmed Abbas |
| Designation |
Assistant Professor Department of Moalajat LUMC |
| Affiliation |
Luqman Unani Medical College Hospital and Research Centre |
| Address |
2nd Floor room number 3 department of Moalijat Luqman Unani Medical College Hospital and Research Centre 12 Naubag Vijayapura
Bijapur
KARNATAKA
586101
India |
| Phone |
08618634591 |
| Fax |
|
| Email |
snisar500@gmail.com |
|
|
Source of Monetary or Material Support
|
| Luqman Unani Medical College Hospital and Research Center 12 Naubag Vijayapura (Bijapur) Karnataka 586101 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine |
| Address |
National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD)
A G’s Colony Road Opposite ESI Metro Station Hyderabad-500038 Telangana State India |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| Mansoori Aliya Fatima |
Luqman unani medical college hospital and research centre |
Ground Floor Roomno 1 General OPD Department of Moalajat LUMC 586101 Bijapur Karnataka
Bijapur
KARNATAKA |
08591300313
mansoorialiya769@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethical Committee for Bio Medical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L210||Seborrhea capitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ab-i Chuqandar (Beta Vugaris) mixed with Bura Armani (Borax) |
Form- Freshly obtain juice of Chuqandar (Beta Vulgaris) mixed with Bura Armani (borax)
Route of Application- Topical on Head
Dosage: Quantity sufficient 10-20 ml daily once
Contact period- 5-10 min then rinse with warm water
frequency daily once
follow up 0th 5th 9th and 14th day |
| Comparator Agent |
Ketoconazole 2% |
Form: Shampoo
Route of application: Topical on head
Contact period:3 to 5 min then rinse with plain water
Dosage: Quantity sufficient 5 ml
Follow up: : 0, 5th, 9th and 14th days
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients of age group of 15 to 65 years with a clinical diagnosis of adherent dandruff of the scalp.
2 Must have active adherent dandruff of the scalp
3 Investigators global assessment (IGA) for pruritis score of at least 1.
4 Understand and willing to sign written informed consent in case of adults and written parental assent in case of children wherever applicable.
|
|
| ExclusionCriteria |
| Details |
1 Pregnant or lactating women by history.
2 History of overt bacterial, viral or fungal infection of the head/neck
3 Patients with history or presence of any serious disease including immunological conditions like HIV, current malignancies, diabetes mellitus. Hypertension, etc.
4History or presence of compromising dermatosis elsewhere on the skin;
5 Patients with damaged skin of scalp
6 Patients with any skin condition e.g., psoriasis, acne, atopic dermatitis;
7 Patients who had used within 1 month prior to baseline any topical and systemic treatment for scalp diseases.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Adherent scalp flaking score (ASFS) |
Baseline 5th day 9th day and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 IGA for pruritus on 4 point scale
2 Dermatology life quality index (DLQI) |
AT Baseline & 14th day |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
14/03/2025 |
| 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="0"
Months="2"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- 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 [mansoorialiya769@gmail.com].
- For how long will this data be available start date provided 22-02-2026 and end date provided 22-03-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nill
|
|
Brief Summary
|
Huzaz (pityriasis capitis) also known as dandruff is a prevalant scalp disorder affecting more than half of world adult population. it is considered the mildest from of seborreic dermatitis involving subclinicaal inflammation. in comparison seborreic dermatitis exihibits a more inflammatroy nature on the scalp. Pityriasis capitis is characterized by increased scalp epidermal proliferation, along with itching and redness. It shows varying levels of severity and is more common in men than women. The condition is most frequently observed in adolescents aged 15-24 years and in older adults above 50 years[4]. The causative organism of pityriasis capitis is Malassezia globosa, a yeast-like fungus that feeds on scalp, feeding on skin oils. Treatment option for dandruff icluding ointment lotions and shampoo. such as zinc pyrithione, salicylic acid, imidazole derivatives, selenium sulfide, tar derivatives, and ketoconazole. However, these synthetic agents are reported to cause side effects like hair loss, increased scaling, itching, nausea, headache, vomiting, photosensitivity, and even cancer. this highlight the need for expooring alternative treatment modakities, where uanani medicine could play a crucial role in providing aq safe and effective treatment. considering all the factors the present study has been desingned to assess the safty and efficacay of a topical unani formulation cosisting of ab-i chuqandar mixed bura armani in managing hazaz comared to ketoconazole 2%. |