| CTRI Number |
CTRI/2017/08/009214 [Registered on: 01/08/2017] Trial Registered Prospectively |
| Last Modified On: |
23/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of unani formulation on dandruff |
|
Scientific Title of Study
|
Clinical Study for Comparative Evaluation of a Unani Formulation in the Management of Huzaz (Dandruff) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yasmeen Ahmed |
| Designation |
MD scolar |
| Affiliation |
Jamia Hamdard university |
| Address |
Department of Maolajat,School of Unani Medicine,Jamia Hamdard,New Delhi
Department of Maolajat,School of Unani Medicine,Jamia Hamdard,New Delhi
South
DELHI
110062
India |
| Phone |
7060888207 |
| Fax |
|
| Email |
yasmeen123ahmed@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof S Shakir Jamil |
| Designation |
Professor |
| Affiliation |
Jamia Hamdard University |
| Address |
Department of Maolajat,School of Unani Medicine,Jamia Hamdard,New Delhi
Department of Maolajat,School of Unani Medicine,Jamia Hamdard,New Delhi
South
DELHI
110062
India |
| Phone |
9873112115 |
| Fax |
|
| Email |
syedshakirjamil@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Umar Jahangir |
| Designation |
Assisstant Professor |
| Affiliation |
Jamia Hamdard University |
| Address |
Department of Maolajat,School of Unani Medicine,Jamia Hamdard,New Delhi
Department of Maolajat,School of Unani Medicine,Jamia Hamdard,New Delhi
South
DELHI
110062
India |
| Phone |
8285684500 |
| Fax |
|
| Email |
umar_jehangir@doctor.com |
|
|
Source of Monetary or Material Support
|
| Jamia Hamdard,Hamdard Nagar, New Delhi
PIN-110062 |
|
|
Primary Sponsor
|
| Name |
Jamia Hamdard |
| Address |
Hamdard Nagar, New Delhi
PIN- 110062 |
| Type of Sponsor |
Other [University] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Moalajat School of Unani Medicine Jamia hamdard |
Hamdard Nagar, New Delhi
PIN- 110062 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Yasmeen Ahmed |
Majeedia Unani Hospital, OPD No. 8 |
Jamia Hamdard, Hamdard Nagar, New Delhi
Pin. 110062
South
DELHI |
7060888207
yasmeen123ahmed@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of Jamia Hamdard |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Dandruff, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Ketoconazol shampoo 1% |
Local application,7ml,thrice a week |
| Intervention |
Zulamla powder |
local application,20 gram,thrice a week |
| Intervention |
Zulamla shampoo |
Local application,7ml,thrice a week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically Diagnosed cases of Huzaz(dandruff)
Provided written informed consent willing to participate in complete test process
Patient using any other medication for dandruff will be included after washed out period of one week
|
|
| ExclusionCriteria |
| Details |
Patient who fail to give consent
Patient who has any hair related disorder such as, Tinea capitis, contact dermatitis, alopecia areata and psoriasis
No hair perming or coloring in the last two months and promised no hair perming or coloring during the study period
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
sign and symptoms
total dandruff score scale
Scalpdex questionairre |
0 day,14th day,28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| scalp scrapping of 10% KOH staining,sebumetery |
0 day,28th day |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
Modification(s)
|
11/05/2018 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
As per the policy laid down by Jamia Hamdard for the purpose. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Proposed open label, randomized, comparative, controlled study and will be carried out in 90 patients of diagnosed cases of Huzaz (dandruff ). Total 90 patients to be randomly allocated to Group A, Group B and Control Group C with 30 in each group. A group-Zulamla formulation, B group-Zulamla in Shampoo base,C group-Ketoconazole Shampoo 1%. Each group will be assessed on 0th,14th and 28th day(end of trial) using various outcome measures including Total Dandruff score scale, Scalpdex questionnaire, Sebumetery, Scalp scrapping for 10% KOH Staining. Safety will be assessed using Clinical and Hematological parameters including CBC, KFT, LFT.The proposed study will provide effective and easily usable treatment of dandruff with least side effect. |