| CTRI Number |
CTRI/2018/03/012687 [Registered on: 20/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
15/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Hair loss in women and its relationship with iron and thyroid hormones |
|
Scientific Title of Study
|
Chronic diffuse hair loss in women A case control study with clinical correlation of serum iron profile and thyroid function |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Snigdha Hegde |
| Designation |
Junior Resident |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of dermatology
K S Hegde Medical Academy
Deralakatte
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9741161631 |
| Fax |
|
| Email |
snighegde@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tonita Noronha |
| Designation |
Associate professor |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of dermatology
K S Hegde Medical Academy
Deralakatte
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9538986093 |
| Fax |
|
| Email |
tones1980@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tonita Noronha |
| Designation |
Associate professor |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of dermatology
K S Hegde Medical Academy
Deralakatte
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9538986093 |
| Fax |
|
| Email |
tones1980@yahoo.com |
|
|
Source of Monetary or Material Support
|
| K S Hegde Medical Academy- nil |
|
|
Primary Sponsor
|
| Name |
Snigdha Hegde |
| Address |
Department of dermatology
K S Hegde Medical Academy
Deralakatte |
| 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 |
| Snigdha Hegde |
K S hegde hospital |
Department of dermatology
OPD no 4
K S Hegde medical academy
Deralakatte
Dakshina Kannada
KARNATAKA |
9741161631
snighegde@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutinal ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy females in the child bearing age group |
| Patients |
Chronic diffuse hair loss, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Inclusion criteria of cases include:
1 Clinically diagnosed chronic diffuse hair loss
a History of diffuse hair loss for more than 6 months
b Daily hair loss count more than 100
c Positive hair pull test
d Absence of central parting and miniaturized vellus hair(to exclude female pattern hair loss)
2 Patient who gave informed consent
3 Women between 18 and 50 years of age
Inclusion criteria of control group:
1. Women between 18 and 50 years of age without a history of hair loss.
2. Persons who gave informed consent.
|
|
| ExclusionCriteria |
| Details |
1 Persons taking iron supplementation
2 Patients with patchy alopecia or signs of inflammatory scalp dermatitis
3 Patients with female patterned hair loss (FPHL)
4 Patients with anticancer chemotherapy and immunosuppressive therapy
5 Patients with concomitant chronic systemic illness
6 Patients with trichodynia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Low serum ferritin and altered thyroid profile in patients with chronic diffuse hair loss |
one year six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Supplementing iron will improve hair loss |
one year six months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/10/2016 |
| Date of Study Completion (India) |
03/09/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
50 women in the child bearing age group with chronic diffuse hair loss as cases and 50 age and sex matched controls will be included in the study. Tests to assess the iron profile of the patients include serum iron, serum ferritin, total iron binding capacity and hemoglobin. The thyroid function will be assessed using T3, T4 and TSH. Scalp examintion using a dermoscope to differentiate chronic diffuse hair loss from other causes is done. |