| CTRI Number |
CTRI/2020/03/023670 [Registered on: 02/03/2020] Trial Registered Retrospectively |
| Last Modified On: |
26/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
STUDY OF ASSOCIATION OF ALOPECIA AND METABOLIC SYNDROME IN YOUNG MEN |
|
Scientific Title of Study
|
“STUDY OF ASSOCIATION OF EARLY ONSET ANDROGENIC ALOPECIA AND METABOLIC SYNDROME IN YOUNG MAN" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priya Rajoriya |
| Designation |
Resident Doctor Dermatology Venereology and Leprosy |
| Affiliation |
Government Medical College Bhavnagar |
| Address |
Flat 302 B wing Shetrunjay Residency opp sir T hospital
Acc colony garampura lakheri dist bundi Rajasthan pincode 323603
Bhavnagar
GUJARAT
364001
India |
| Phone |
7597394168 |
| Fax |
|
| Email |
dr.priyarajoriya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hita Mehta |
| Designation |
Professor & Head Department of Dermatology Venereology and Leprosy |
| Affiliation |
Government Medical College Bhavnagar |
| Address |
SKIN OPD 115 SIR T HOSPITAL GOVERNMENT MEDICAL COLLEGE BHAVNAGAR GUJARAT
Bhavnagar
GUJARAT
364001
India |
| Phone |
9429563188 |
| Fax |
|
| Email |
hitamehta88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya Rajoriya |
| Designation |
Resident Doctor |
| Affiliation |
Government Medical College Bhavnagar |
| Address |
Flat 302 B wing Shetrunjay Residency opp Sir T Hospital
Acc colony garampura lakheri dist bundi Rajasthan pincode 323603
Bhavnagar
GUJARAT
364001
India |
| Phone |
7597394168 |
| Fax |
|
| Email |
dr.priyarajoriya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dermatology Venereology and leprosy Sir T Hospital Bhavnagar |
|
|
Primary Sponsor
|
| Name |
Department of Dermatology Venereology and Leprosy |
| Address |
Room no. 115 Department of Dermatology Venereology and Leprosy Sir T Hospital Bhavnagar, Gujarat |
| Type of Sponsor |
Government medical college |
|
|
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 Priya Rajoriya |
Sir Takthsinhji Hospital Bhavnagar |
Room no 115, Department of Dermatology Venereology and Leprosy
Bhavnagar
GUJARAT |
7597394168
dr.priyarajoriya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB GMC Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients of Androgenic Alopecia and Age matched control, |
|
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Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Male |
| Details |
Male patient of androgenic alopecia of age group 15 to 35 year will be included in this study.
All patient of grade I to VII (According to Hamilton-Norwood classification).
Patient who will giving written consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Female patient of androgenic alopecia.
Age group <15years or >35 years.
Patient not willing to participate in the study.
Patient not giving consent.
Patient with severe seborrheic dermatitis, alopecia diseases( except AGA) and scalp disorder such as scalp psoriasis and infection.
Patient taking specific drug which can cause alopecia such as corticosteroid, vascular dilators , antihypertensive , anticonvulsant , B-blockers , bronchodilators, diuretics , cimetidine , diazoxide , cyclosporine, ketoconazole ,over the previous 6 months.
Past history of major illness like stroke, cancer, cardiovascular disease, renal disease, Insulin dependent Diabetes Mellitus before 6 months.
Patients having other dermatological disorder which leads to hair loss like SLE, Pemphigus vulgaris. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Metabolic syndrome criteria
BP more than 130/85, HDL less than 40,SerumTG morethan150,waist circumference more than 102.
FBS110,waist circumference102 |
1year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
24/03/2018 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Androgenic alopecia (AGA) is the most common cause of hair loss in male population. It affects up to 50% of men worldwide. The onset of androgenic alopecia before 35 years of age is known as an early onset androgenic alopecia. Aims of our study are study the pattern of early onset male androgenic alopecia (AGA) and its association with metabolic syndrome. Total 200 male patients between the age of 15 to 35 years, in which 100 cases with androgenic alopecia either of Grade I to VII ( according to Hamilton –Norwood classification of hair loss) and 100 age matched controls without AGA would be enrolled in the study after taking consent . A detailed clinical history and dermatological examination will be carried out including age of onset, duration of alopecia, family history and previous non medical hair care history.Grading of AGA (according to Hamilton –Norwood classification of hair loss). Metabolic Syndrome will be defined according to the National Cholesterol Education Program Adult Treatment Panel III criteria which including Waist circumference > 102cm,Triglyceride value > 150mg/dl, HDL-C <40mg/dl, FBS > 110mg/dl, BP > 130/85mm of Hg.
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