| CTRI Number |
CTRI/2025/10/096662 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical, Anthropometric and Hormonal Study in Patients Of Female Pattern Hair Loss. |
|
Scientific Title of Study
|
A Study of Clinical, Anthropometric and Hormonal association in Patients Of Female Pattern Hair Loss and healthy controls. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Niki Patel |
| Designation |
1st year PG Resident |
| Affiliation |
GCS Medical College Hospital and Research Centre |
| Address |
OPD 35,Ground floor,GCS Medical College Hospital and Research
Centre Opp DRM Office Near Chamunda Bridge Naroda Road
Ahmedabad Ahmadabad GUJARAT 380025 India
Ahmadabad
GUJARAT
380025
India
Ahmadabad
GUJARAT
38025
India |
| Phone |
9426897360 |
| Fax |
|
| Email |
patelniki311@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan H Patel |
| Designation |
Professor and HOD |
| Affiliation |
GCS Medical College Hospital and Research Centre |
| Address |
OPD 35, ground floor,GCS Medical College Hospital and Research
Centre,Opp DRM Office Near Chamunda Bridge Naroda Road
Ahmedabad Ahmadabad GUJARAT 380025 India
Ahmadabad
GUJARAT
380025
India
Ahmadabad
GUJARAT
380025
India |
| Phone |
9925011309 |
| Fax |
|
| Email |
nayan.patel@gcsmc.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nayan H Patel |
| Designation |
Professor and HOD |
| Affiliation |
GCS Medical College Hospital and Research Centre |
| Address |
OPD 35, ground floor,GCS Medical College Hospital and Research
Centre,Opp DRM Office Near Chamunda Bridge Naroda Road
Ahmedabad Ahmadabad GUJARAT 380025 India
Ahmadabad
GUJARAT
380025
India
Ahmadabad
GUJARAT
380025
India |
| Phone |
9925011309 |
| Fax |
|
| Email |
nayan.patel@gcsmc.org |
|
|
Source of Monetary or Material Support
|
| GCS hospital Opp. D.R.M. Office, Naroda Rd, nr. Chamunda Bridge, Ahmedabad, Gujarat 380025 Ahmadabad GUJARAT 380025 India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [] |
|
|
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 |
| Patel Niki |
GCS Medical College Hospital & Research Centre |
Department of
dermatology GCS
Medical College
Hospital and Research
Centre Opp DRM Office
Near Chamunda Bridge
Naroda Road
Ahmedabad
Ahmadabad GUJARAT
Ahmadabad
GUJARAT
Ahmadabad
GUJARAT |
9426897360
patelniki311@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee GCS medical college,hospital and reasearch centre(IECGCSMCHRC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L649||Androgenic alopecia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
46.00 Year(s) |
| Gender |
Female |
| Details |
Case:
1.Female patients with clinical and trichoscopic diagnosis of FPHL.
2.Age between 12-46 year
Control:
1.Age-matched healthy females without hair loss.
2.No known dermatological or systemic conditions affecting hair.
|
|
| ExclusionCriteria |
| Details |
1.Any pre-existing endocrine disorder like diabetes mellites and thyroid disorder
2.Any known genetic condition effecting the hair
3.Associated Auto immune condition affecting hair like alopecia areata, systemic lupus erythematous
4.Patients on hormonal therapy, hair treatments, or medications affecting hair growth or taking OC Pills in last 2 years
5.Pregnant and lactating females
6.History of abortion in last six months
7.History of any major medical or surgical illness in last six months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To determine difference of clinical parameters in subjects with and without FPHL
2.To determine difference of anthropometric parament in subjects with and without FPHL
3.To determine difference of hormonal profile in subjects with and without FPH |
day 0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To determine the corelation of clinical features & anthropometric parameters in patient of FPHL
2.To determine corelation of the urinary metabolites of androgen metabolism like androstenediol & Androsterone with clinical features in patient of FPH |
day 0 |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
22/11/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Female Pattern Hair Loss (FPHL), also known as androgenetic alopecia, is a progressive, non-scarring alopecia that primarily affects women, leading to significant psychological distress and diminished quality of life. The prevalence of FPHL is increasing in India, yet comprehensive epidemiological and clinical studies remain limited. The pathophysiology of FPHL is multifactorial, involving genetic predisposition, hormonal imbalances, and environmental factors Female Pattern Hair Loss (FPHL) is a common non-scarring alopecia characterized by progressive thinning of hair over the central and frontal scalp regions, most commonly observed in women after puberty. Although often considered a cosmetic issue, emerging evidence suggests that FPHL may be associated with underlying hormonal and metabolic disturbances, including hyperandrogenism, insulin resistance, and features of metabolic syndrome. The present study, titled “Clinical, Anthropometric and Hormonal Study in Patients of Female Pattern Hair Loss,” is designed as a hospital-based, epidemiological, observational, analytic, case control study to investigate and compare the clinical profile, anthropometric measurements, and hormonal parameters in women with FPHL and age-matched healthy controls. The study population includes 76 female patients aged 12 to 46 years clinically diagnosed with FPHL based on the Ludwig classification, along with age-matched controls without clinical signs of hair loss. A comprehensive clinical assessment, trichoscopic examination, and anthropometric evaluation including body mass index (BMI), waist-hip ratio, mid-arm circumference, and body composition analysis will be conducted. In addition, blood samples will be collected to measure hormonal parameters such as serum total and free testosterone, DHEAS, LH, FSH, and prolactin. The primary objective is to determine differences in hormonal and anthropometric profiles between cases and controls, with a view to identifying potential markers that may correlate with disease severity. The sample size was calculated using standard statistical formulas for comparing means, and was based on published reference values for DHEAS and BMI , resulting in an estimated requirement of 38 participants per group to ensure adequate power for both primary outcomes. Statistical analysis will involve appropriate parametric or non-parametric tests to assess the significance of observed differences. This study is expected to contribute to the understanding of FPHL as a multifactorial disorder with systemic implications and may offer insights into early diagnosis, risk stratification, and individualized management strategies. |