| CTRI Number |
CTRI/2014/11/005187 [Registered on: 07/11/2014] Trial Registered Retrospectively |
| Last Modified On: |
07/11/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Deficiencies In Chronic Diffuse Hair Loss In Women |
|
Scientific Title of Study
|
Role Of Serum Ferritin And Thyroid Function In Chronic Diffuse Hair Loss In Women |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Charisma Kunhi Khannan |
| Designation |
First Year Resident |
| Affiliation |
Father Muller Medical College |
| Address |
Department of Dermatology
Father Muller Medical College
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9886868718 |
| Fax |
|
| Email |
charismakk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nanda Kishore B |
| Designation |
Professor and Unit Head |
| Affiliation |
Father Muller Medical College |
| Address |
Department of Dermatology
Father Muller Medical College
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9343567927 |
| Fax |
|
| Email |
drnandakishoreb@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nanda Kishore B |
| Designation |
Professor and Unit Head |
| Affiliation |
Father Muller Medical College |
| Address |
Department of Dermatology
Father Muller Medical College
Kankanady
Mangalore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9343567927 |
| Fax |
|
| Email |
drnandakishoreb@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Father Muller Medical College |
|
|
Primary Sponsor
|
| Name |
Dr Charisma Kunhi Khannan |
| Address |
Department of Dermatology Father Muller Medical College
Kankanady
Mangalore |
| Type of Sponsor |
Other [Self] |
|
|
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 Nanda Kishore B |
Father Muller Medical College |
room no. 35, Department of Dermatology
father muller medical college
Kankanady
Dakshina Kannada
KARNATAKA |
9343567927
drnandakishoreb@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Chronic Diffuse Hair Loss, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients with complaints of diffuse hair loss of more than 6 months duration
2. Women of the age group of 15- 45 years
3. Patients willing for the required investigations with a written informed consent
|
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating women.
2. Women with chronic systemic disease in the past 6 months.
3. Women who used medication associated with hair loss in last 3 months.
4. Patients not willing for necessary investigations.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Results of serum ferritin, serum hemoglobin, thyroid function test |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| serum ferritin , serum hemoglobin, thyroid function tests |
6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2013 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hair is considered to be a major component of an individual’s general appearance. The psychological impact of hair loss results in a measurably detrimental change in self-esteem and is associated with images of reduced worth. Chronic loss of scalp hair is a common problem among middle aged women.Many cases of telogen effluvium are subclinical, so the true incidence in the community is unknown.Observational studies have suggested that alopecia in women maybe associated with decreased body iron stores or with an underlying thyroid disorder. Only few epidemiological studies have addressed the etiology and risk factors for chronic hair loss.Thus, the present study has been taken up to assess the association between serum ferritin and thyroid functions in chronic diffuse hair loss. |