| CTRI Number |
CTRI/2020/03/023897 [Registered on: 11/03/2020] Trial Registered Prospectively |
| Last Modified On: |
04/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Herbal treatment for premature greying of hair |
|
Scientific Title of Study
|
Efficacy of Itrifal Sagheer and Hair Oil Formulation in Premature Hair Greying - An open labelled, interventional clinical study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohammed Uwais Faisal |
| Designation |
P.G. Scholar, Dept. of Amraze Jild wa Tazeeniyat, National Institute of Unani Medicine |
| Affiliation |
National Institute of Unani Medicine |
| Address |
National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore .
Bangalore
KARNATAKA
560091
India |
| Phone |
8109223946 |
| Fax |
|
| Email |
uwaisfaisal007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Qutubuddin |
| Designation |
Lecturer, Dept. of Amraze Jild wa Tazeeniyat, National Institute of Unani Medicine |
| Affiliation |
National Institute of Unani Medicine |
| Address |
National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore.
Bangalore
KARNATAKA
560091
India |
| Phone |
9810789655 |
| Fax |
|
| Email |
drqutubkhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohammed Uwais Faisal |
| Designation |
P.G. Scholar, Dept. of Amraze Jild wa Tazeeniyat, National Institute of Unani Medicine |
| Affiliation |
National Institute of Unani Medicine |
| Address |
National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore.
Bangalore
KARNATAKA
560091
India |
| Phone |
8109223946 |
| Fax |
|
| Email |
uwaisfaisal007@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicines and hospital, kottigeplya banglore |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore. |
| 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 |
| Mohammed Uwais Faisal |
National Institute of Unani Medicine |
Dept. of Amraze Jild wa Tazeeniyat, OPD NO. 4, Kottigepalya, Magadi Main Road, Bangalore.
Bangalore
KARNATAKA |
8109223946
uwaisfaisal007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Desicion of the Institutional Ethics Committee(IEC) for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L679||Hair color and hair shaft abnormality, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Itrifal Sagheer and Unani Hair Oil
|
In under trial patients, Itrifal Sagheer 10gm orally at bed time,
Hair Oil will be applied topically once a day for 60 days. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed patients of PHG.
Patients of either gender.
Patients in the age group of 15 to 35 years.
Patients who have agreed to sign the informed consent form and follow the protocol.
|
|
| ExclusionCriteria |
| Details |
Patient suffering from any type of hair and scalp diseases like psoriasis, Eczema & Seborrhoic dermatitis.
Patient suffering from chronic systemic and metabolic diseases like DM, HIV, severe asthma, Cardiac diseases.
History of any treatment for hair loss and hair greying within the previous one month.
History of dyeing within the previous one month.
Premature aging disorder such as progeria.
Pregnant & Lactating Women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Greying severity score (GSS)
The total score includes the scores of colour of the hair.
|
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Photograph of the affected area of scalp. |
60 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/03/2020 |
| 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
|
after complition of the trial, paper will be published in peer reviwed, international journal. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A clinical study on the topic efficacy of Itrifal Sagheer and Hair Oil formulation in premature hair greying (PHG) will be conducted in National Institute of Unani medicine, Bangalore. The formulation will be used in the form of Itrifal for oral use and Hair Oil for topical application. Total duration of the study is 60 days. The present test formulation has been extensively used by the eminent physicians in the treatment of Premature Hair Greying and is proverbially known for its efficacy and safety. Diagnosed patients of PHG fulfilling the inclusion criteria will be enrolled for the clinical trial. After obtaining their written informed consent they will be given test drug in the form of Itrifal Sagheer orally and hair oil for topical application.Primary outcome measure is greying severity score (GSS) and the total score includes the scores of colour of the hair. while Secondary outcome measure includes photograph of the affected area of scalp.The efficacy of the treatment will be determined by decrease in grades from higher to lower i.e. from severe to moderate, moderate to mild and mild to healthy hair. |