| CTRI Number |
CTRI/2024/07/071311 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to evaluate the changes in bone mineral density and gradings of hair-fall in women |
|
Scientific Title of Study
|
A case control non-randomized study to evaluate the changes in bone mineral density and gradings of keshapatana (hair-fall) in women |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monika |
| Designation |
MD Scholar |
| Affiliation |
Shri Dhanwantry Ayurvedic College and Hospital Sector 46B Chandigarh |
| Address |
Shri Dhanwantry Ayurvedic College and Hospital, Sector 46B Chandigarh
A107, Roga Nidana evum vikriti vigayana department
Shri Dhanwantry Ayurvedic College and Hospital, Sector 46B, Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
8847496938 |
| Fax |
|
| Email |
drmonikasharehel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Monika |
| Designation |
MD Scholar |
| Affiliation |
Shri Dhanwantry Ayurvedic College and Hospital Sector 46B Chandigarh |
| Address |
Shri Dhanwantry Ayurvedic College and Hospital Sector 46B Chandigarh
A107, Roga Nidana evum vikriti vigayana department
Shri Dhanwantry Ayurvedic College and Hospital, Sector 46B, Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
8847496938 |
| Fax |
|
| Email |
drmonikasharehel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Monika |
| Designation |
MD Scholar |
| Affiliation |
Shri Dhanwantry Ayurvedic College and Hospital Sector 46B Chandigarh |
| Address |
Shri Dhanwantry Ayurvedic College and Hospital Sector 46B Chandigarh
A107, Roga Nidana evum vikriti vigayana department
Shri Dhanwantry Ayurvedic College and Hospital, Sector 46B, Chandigarh
Chandigarh
CHANDIGARH
160047
India |
| Phone |
8847496938 |
| Fax |
|
| Email |
drmonikasharehel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dhanwantry ayurvedic college and hospital, sector 46B, chandigarh, pin: 160047, India |
|
|
Primary Sponsor
|
| Name |
Monika |
| Address |
Shri Dhanwantry ayurvedic college and hospital, sector 46B, Chandigarh, pin: 160047, India |
| Type of Sponsor |
Other [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 Sumit Srivastava |
Shri Dhanwantry ayurvedic college and hospital |
A107, Department of Roga Nidana Evum Vikriti Vigayana
Chandigarh
CHANDIGARH |
7986502791
sumitpankaj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Shri Dhanwantry ayurvedic college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hair-fall (Keshapatana) |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Women between 20 to 50 years of age having hair fall
According to Sinclair Hair Shedding Scale subjects under grade 1 to 4 will be under control group A and grade 5 to 6 will be taken for case group B |
|
| ExclusionCriteria |
| Details |
Diagnosed cases of cancer with chemotherapy going on or any major illness
Congenital anomalies having hair-fall as symptom
Hair falls due to skin diseases, seborrheic dermatitis, scalp psoriasis, etc
Pregnant women
Lactating women
Menopausal women
Subjects unfit for BMD test |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The relation between changes in BMD and gradings of
Keshapatana in women will be evaluated |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the hair-fall grading through Sinclair hair Shedding Scale in women with the age group of 20-50 years
To assess the BMD score in women with the age group of 20-50 years. |
4 months |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
05/08/2024 |
| 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="0"
Months="11"
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
|
|