| CTRI Number |
CTRI/2025/05/087793 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
27/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Other (Specify) [Hair care ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to evaluate the effectiveness of an Unani Shampoo in the management of Dandruff |
|
Scientific Title of Study
|
A Randomized Contrlled Two arm Clinical Trial to Evaluate the Eficacy of a Compound Unani Formula in case of Dandruff |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr MEENAZ FATHIMA |
| Designation |
PG Scholar |
| Affiliation |
Government Nizamia Tibbi College and General Hospital |
| Address |
OPD 1 Room no. 1,PG Department of Moalejat, Government Nizamia Tibbi College and General Hospital charminar
Hyderabad
TELANGANA
500002
India |
| Phone |
7981830570 |
| Fax |
|
| Email |
drmeenazfathima1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S A KHADIR HUSSAINI |
| Designation |
Professor |
| Affiliation |
Government Nizamia Tibbi College and General Hospital |
| Address |
OPD 1 Room no. 1,PG Department of Moalejat, Government Nizamia Tibbi College and General Hospital charminar
Hyderabad
TELANGANA
500002
India |
| Phone |
9704888561 |
| Fax |
|
| Email |
sakhussaini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S A KHADIR HUSSAINI |
| Designation |
Professor |
| Affiliation |
Government Nizamia Tibbi College and General Hospital |
| Address |
OPD 1 Room no. 1,PG Department of Moalejat, Government Nizamia Tibbi College and General Hospital charminar
Hyderabad
TELANGANA
500002
India |
| Phone |
9704888561 |
| Fax |
|
| Email |
sakhussaini@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Nizamia Tibbi College and General Hospital |
|
|
Primary Sponsor
|
| Name |
Government Nizamia Tibbi College and General Hospital |
| Address |
Government Nizamia Tibbi College and General Hospital charminar Hyderabad Telangana 500002 |
| 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 MEENAZ FATHIMA |
Government Nizamia Tibbi College and General Hospital |
OPD Room no 1 PG Department of Moalijat gen medicine Government Nizamia Tibbi College and General Hospital Charminar Hyderabad TELANGANA 500002 India
Hyderabad
TELANGANA
Hyderabad
TELANGANA |
7981830570
drmeenazfathima1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC), Government Nizamia Tibbbi College, Hyderabad |
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 |
| Intervention |
hair shampoo |
Make shampoo
Equal Quantities Preparation:
- Take 10 grams of each of the following drugs: Nakhood, Baqila, Turmus, Khatmi, and Methi. use it to apply 2 times a week for 45day
|
| Comparator Agent |
hair shampoo |
Ketoconazole 2% shampoo twice a week for 45 days |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Both sexes
Age 13 to 50 years
Patients
Excoriation Pruritus Grading EPG
Adherent Scalp Flaking Score ASFS
with any signs and symptoms of
hazaz or Bafa Dandruff
|
|
| ExclusionCriteria |
| Details |
Patients diagnosed with other scalp diseases
Patients who had received any systemic or topical antimycotic therapy within a month of the start of the study
Patients undergoing chemotherapy or radiotherapy
Immunocompromised patients |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Excoriation pruritus grading. (EPG)
Adherent Scalp Flaking Score (ASFS)
trying to bring the score below 7 |
Within 45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
15/06/2025 |
| 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="6"
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
|
ยท Dandruff also called pityriasis capitis or seborrheic dermatitis is a chronic scalp condition affecting over half the global population Recognized since ancient times it is referred to in Unani medicine as Hazaz or Bafa meaning scalp flakes and dryness It typically begins around or after puberty and is more common in males likely due to androgen involvement Dandruff can impact self esteem and social interactions due to its persistent and visible nature Its cause is multifactorial with the yeast Malassezia playing a key role by breaking down sebum and releasing fatty acids which irritate the scalp and lead to excessive flaking Conventional treatments may cause side effects like itching dryness and dermatitis limiting their use Unani literature offers alternative remedies One such formula was made into a shampoo and tested on albino rats showing no allergic reaction A clinical trial on humans is now planned to assess its safety and effectiveness |