| CTRI Number |
CTRI/2024/03/063692 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Treatment of long term Anemia |
|
Scientific Title of Study
|
Effect of Hydroxyurea on fetal hemoglobin(HbF) in sickle cell anemia and its impact on splenic function and biochemical parameters in a tertiary care hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SURA AMARENDAR |
| Designation |
assistant professor |
| Affiliation |
Namo medical Education and Research Institute |
| Address |
Department of Pharmacology
Namo Medical Education and Research Institute, Sayli, Silvassa.
Dadra & Nagar Haveli
DADRA & NAGAR HAVELI
396240
India |
| Phone |
8639394262 |
| Fax |
|
| Email |
amarendarsura@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalini Chandra |
| Designation |
Professor |
| Affiliation |
Rohilkhand Medical college and Hospital |
| Address |
Department of Pharmacology
Rohilkhand Medical college and Hospital, Bareilly international University
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9997733097 |
| Fax |
|
| Email |
dr.shalini.chandra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shalini Chandra |
| Designation |
Professor |
| Affiliation |
Rohilkhand Medical college and Hospital |
| Address |
Department of Pharmacology
Rohilkhand Medical college and Hospital, Bareilly international University
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9997733097 |
| Fax |
|
| Email |
dr.shalini.chandra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand medical college and Hospital, Bareilly, UP |
|
|
Primary Sponsor
|
| Name |
Sura. Amarendar |
| Address |
Department of Pharmacology
Namo Medical Education and research institute
silvassa DNH 396240 |
| Type of Sponsor |
Other [Sura amarendar] |
|
|
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 |
| Sura Amarendar |
Shri Vinoba Bhave Civil Hospital (SVBCH), and Namo medical education and research institute |
sickle cell project office room no.33 Silvassa, DNH, 396240
Dadra & Nagar Haveli
DADRA & NAGAR HAVELI |
8639394262
amarendarsura@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee of NAMO medical education and Research instittute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D638||Anemia in other chronic diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Painful crises (in the past 12 months, there were more than three occurrences)
More than two blood transfusions in the last 12 months. The term "painful crisis" refers to an acute painful occurrence that necessitates the use of oral or injectable analgesics and lasts for at least 4 hours when no other reason can be found to account for the symptom
Patients under hydroxyurea therapy will be approached to enrol in this study to assess splenic hypofunction |
|
| ExclusionCriteria |
| Details |
children under the age of 3years and adults over 60years of age
concomitant diseases such as neutropenia and thrombocytopenia may have increased the hydroxyureas toxicity
Patients who are participating in a particular program or study that could have had an impact on their clinical or haematological state
renal dysfunction is indicated by blood creatinine levels that are 1.5 time or more above normal |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Anticipate a statistically significant increase in HbF levels in Sickle Cell Anemia patients following Hydroxyurea treatment. |
4weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Expect improvement in splenic function, as evidenced by imaging techniques, attributed to the reduction of sickle cell-related complications and improved overall hemoglobin profiles.
Envisage a reduction in the frequency and severity of vaso-occlusive crises, leading to improved patient quality of life
|
1year |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
14/03/2024 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - amarendarsura@gmail.com
- For how long will this data be available start date provided 02-03-2024 and end date provided 02-03-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This study intended to evaluate the effectiveness of Hydroxyurea on
sickle cell patients by clinical and laboratory findings, splenic function and
long-term compliance |