| CTRI Number |
CTRI/2024/06/068563 [Registered on: 07/06/2024] Trial Registered Prospectively |
| Last Modified On: |
03/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Other (Specify) [THERAPEUTIC] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study on The Efficacy of two Unani Formulations in the management of Dandruff |
|
Scientific Title of Study
|
A Single Blind Randomised Clinical Study on the Efficacy of Two Unani formulations in the management of Huzaz (Dandruff) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maleeha Zehra |
| Designation |
PG Scholar |
| Affiliation |
Ajmal Khan Tibbiya College |
| Address |
Department of Amraz e Jild wa Zohrawiya, Ajmal Khan Tibbiya College, AMU, Aligarh
Faculty of Unani Medicine, AMU, Aligarh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
7906383598 |
| Fax |
|
| Email |
syedazhar19570@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Zamir Ahmad |
| Designation |
Professor |
| Affiliation |
Ajmal Khan Tibbiya College |
| Address |
Department of Amraz e Jild wa Zohrawiya, Ajmal Khan Tibbiya College, AMU, Aligarh
Faculty of Unani Medicine, AMU, Aligarh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8475007594 |
| Fax |
|
| Email |
drzamiramrohi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Maleeha Zehra |
| Designation |
PG Scholar |
| Affiliation |
Ajmal Khan Tibbiya College |
| Address |
Department of Amraz e Jild wa Zohrawiya, Ajmal Khan Tibbiya College, AMU, Aligarh
Faculty of Unani Medicine, AMU, Aligarh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
7906383598 |
| Fax |
|
| Email |
syedazhar19570@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Amraz e Jild wa Zohrawiya,Ajmal Khan Tibbiya College, AMU, Aligarh, India, 202001 |
|
|
Primary Sponsor
|
| Name |
Department of Amraz e Jild wa Zohrawiya |
| Address |
Ajmal Khan Tibbiya College, Faculty of Unani Medicine, AMU, Aligarh, 202001 |
| 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 Maleeha Zehra |
Ajmal Khan Tibbiya College and Hospital l |
Department of Amraz e Jild wa Zohrawiya, F/O Unani Medicine, AMU, Aligarh
Aligarh
UTTAR PRADESH |
7906383598
syedazhar19570@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Department of Amraz e Jild wa Zohrawiya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L219||Seborrheic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparative drug
Chuqandar (Beetroot) – Beta vulgaris
Sirka (Vinegar)
|
Solution of Chuqandar (beetroot)-Beta vulgaris and
Sirka (vinegar) to be applied thrice weekly for a period of 4 weeks in the form of hair wash (quantity sufficient). |
| Intervention |
Test drug
Hulba (Fenugreek) Trigonella foenum graecum
Sirka (Vinegar)
|
Solution of Hulba (Fenugreek) Trigonella foenum graecum, and Sirka (vinegar) to be applied thrice weekly for a period of 4 weeks in the form of a hair wash (quantity sufficient).
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex above 18 years of age.
2. Patients with Adherent Scalp Flaking Score (ASFS) up to grade 3 i.e., thick heaped-up scales but not forming plaque.
3.Patients who agreed to sign the consent form
|
|
| ExclusionCriteria |
| Details |
1. Patients below 18 years of age.
2. Patients who underwent local procedures within the past 2 weeks or during the study.
3. pregnant or lactating females.
4. Patients with other concomitant skin diseases like psoriasis, Tinea capitis, eczema and atopic dermatitis (as per history and clinical examination).
5. Patients using other topical medications, including medicated shampoos/oils or antibiotics, within past 2 weeks or during course of trial.
6. Patients suffering from severe systemic illness
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Adherent Scalp Flaking Score |
0, 7th, 14th and 21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in scalp itching and flaking |
0,7th, 14th and 21st day |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/07/2024 |
| 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
|
AIMS AND OBJECTIVES OF THE STUDY: To evaluate the safety and efficacy of Hulba (Fenugreek) solution and Chuqandar (Beetroot) solution in the management of Huzaz. To compare the effects of Hulba solution and Chuqandar solution in the management of Huzaz
PURPOSE AND BACKGROUND OF THE STUDY: Dandruff is a chronic disease with relapses and remissions. Hence, for its long-term management, it is imperative to search for medicines that are efficacious and have the least adverse effects. |