| CTRI Number |
CTRI/2024/10/075191 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
11/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical Study to observe the presence of muscle loss and loss of muscle strength in patients of Hemophilia |
|
Scientific Title of Study
|
A study to find out the Occurence of sarcopenia in Hemophilia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SOUMIA M |
| Designation |
Post Graduate resident second year |
| Affiliation |
Maulana Azad medical college and Lok Nayak hospital |
| Address |
Department of medicine , Maulana Azad medical college and Lok Nayak hospital ,Delhi
New Delhi
DELHI
110002
India |
| Phone |
6381338856 |
| Fax |
|
| Email |
souvasa3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Sunita Aggarwal |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad medical college and Lok Nayak hospital |
| Address |
BL Taneja Block ,Department of medicine , Maulana Azad medical college and Lok Nayak hospital ,Delhi
New Delhi
DELHI
110002
India |
| Phone |
9968281414 |
| Fax |
|
| Email |
drsunita.mamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SOUMIA M |
| Designation |
Post Graduate resident second year |
| Affiliation |
Maulana Azad medical college and Lok Nayak hospital |
| Address |
Department of medicine , Maulana Azad medical college and Lok Nayak hospital ,Delhi
New Delhi
DELHI
110002
India |
| Phone |
6381338856 |
| Fax |
|
| Email |
souvasa3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad medical college, Bahadur shah Zafar marg ,New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad medical college |
| Address |
Bahadur shah Zafar marg ,new delhi, 110002 |
| 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 |
| DrSoumia |
Lok Nayak hospital |
Hemophilia day care centre ,department of medicine ,ground floor , Lok Nayak hospital ,delhi
New Delhi
DELHI |
6381338856
Souvasa3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad medical college ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D66||Hereditary factor VIII deficiency, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
Any Haemophilia more than 12 years of age. |
|
| ExclusionCriteria |
| Details |
Patients who are a known case of bleeding disorders other than hemophilia |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of sarcopenia in hemophilia |
At the baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association of risk factors with sarcopenia |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
22/10/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Sarcopenia is associated with hemophilia and is mostly attributed to disuse atrophy .hence symptoms of haemophilia can initiate a cycle of pain,physical inactivity,muscle weakness and muscle atrophy and increased bleeding risk .Sarcopenia is feasible and useful as an integrative marker for comprehensively measuring the impact of illness and treatment on overall health status.
4 Hence it is useful to find out the occurrence of sarcopenia in Hemophilia ,in order to know about the impact it creates on the quality of life of hemophilia patients and to aid in the improvement of The same |