| CTRI Number |
CTRI/2023/05/053122 [Registered on: 25/05/2023] Trial Registered Prospectively |
| Last Modified On: |
24/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effectiveness of two medicines(sodium tetradecyl sulphate versus bleomycin)in the non-operative management of slow flow vascular malformations by sclerotherapy |
|
Scientific Title of Study
|
Comparative analysis of intralesional sclerotherapy with sodium tetradecyl sulphate versus bleomycin in the management of slow flow vascular malformations |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ANUBHAV AGARWAL |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE AND HOSPITAL (JNMCH), A.M.U., Aligarh |
| Address |
DEPARTMENT OF RADIO-DIAGNOSIS, JNMCH, AMU, ALIGARH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7302634060 |
| Fax |
|
| Email |
vgoodmorning5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SAIFULLAH KHALID |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE AND HOSPITAL (JNMCH), A.M.U., Aligarh |
| Address |
DEPARTMENT OF RADIO-DIAGNOSIS, JNMCH, AMU
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9897218098 |
| Fax |
|
| Email |
saif2k2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SAIFULLAH KHALID |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
JAWAHARLAL NEHRU MEDICAL COLLEGE AND HOSPITAL (JNMCH), A.M.U., Aligarh |
| Address |
DEPARTMENT OF RADIO-DIAGNOSIS, JNMCH, AMU
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9897218098 |
| Fax |
|
| Email |
saif2k2@gmail.com |
|
|
Source of Monetary or Material Support
|
| JAWAHARLAL NEHRU MEDICAL COLLEGE AND HOSPITAL, (JNMCH) A.M.U., Aligarh , Uttar Pradesh (202001) |
|
|
Primary Sponsor
|
| Name |
JAWAHARLAL NEHRU MEDICAL COLLEGE AND HOSPITAL JNMCH AMU ALIGARH UTTAR PRADESH |
| Address |
DEPARTMENT OF RADIO-DIAGNOSIS, JNMCH, AMU, ALIGARH, UTTAR PRADESH |
| 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 SAIFULLAH KHALID |
JAWAHARLAL NEHRU MEDICAL COLLEGE AND HOSPITAL (JNMCH), A.M.U., ALIGARH |
DEPARTMENT OF RADIO-DIAGNOSIS, ULTRASOUND COMPLEX (ROOM NO.302), NON-VASCULAR INTERVENTION SUITE
Aligarh
UTTAR PRADESH |
9897218098
saif2k2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q279||Congenital malformation of peripheral vascular system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
BLEOMYCIN |
BLEOMYCIN IS A SCLEROSING AGENT USED IN THE TREATMENT OF SLOW FLOW VASCULAR MALFORMATIONS, IT IS ALSO AN ANTI-CANCER DRUG USED FOR CHEMOTHERAPY
DOSE - 15 IU or 1 ampoule
CONCENTRATION - 15 IU reconstituted in 5ml of Normal Saline
ROUTE OF ADMINISTRATION - INTRA-LESIONAL INJECTION UNDER ULTRASOUND GUIDANCE
FREQUENCY OF ADMINISTRATION - A maximum of 2 doses ; 2nd dose to be given 4-6 weeks after the 1st dose |
| Intervention |
SODIUM TETRADECYL SULPHATE |
SCLEROSING AGENT USED IN THE TREATMENT OF SLOW FLOW VASCULAR MALFORMATIONS, ACTS BY CAUSING FIBROSIS OF VESSEL WALLS
DOSE - 2ml/60mg
CONCENTRATION - 30 mg/ml
ROUTE OF ADMINISTRATION - INTRA-LESIONAL INJECTION UNDER ULTRASOUND GUIDANCE
FREQUENCY OF ADMINISTRATION - A maximum of 2 doses ; 2nd dose to be given 4-6 weeks after the 1st dose |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ALL PATIENTS HAVING SLOW FLOW VASCULAR MALFORMATIONS AND REQUIRING TREATMENT AND GIVING CONSENT FOR SCLEROTHERAPY |
|
| ExclusionCriteria |
| Details |
ALL PATIENTS HAVING SLOW FLOW VASCULAR MALFORMATIONS NOT REQUIRING TREATMENT OR NOT GIVING CONSENT FOR SCLEROTHERAPY |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| OVERALL REDUCTION IN SIZE/VOLUME AND VASCULARITY/FLOW RATE AFTER INTRA-LESIONAL SCLEROTHERAPY WITH SODIUM TETRADECYL SULFATE AND BLEOMYCIN |
BASELINE, THEN 4-6 WEEKS AFTER FIRST SITTING, THEN 4-6 WEEKS AFTER SECOND SITTING |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SURGICAL OUTCOME AND THE EASE OF OPERABILITY IN CASE OPERATED |
24 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
02/06/2023 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT APPLICABLE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
I INTEND TO A RANDOMISED CONTROLLED TRIAL IN ORDER TO EVALUATE THE COMPARATIVE EFFICACY OF BLEOMYCIN VERSUS SODIUM TETRADECYL SULFATE IN TERMS OF OVERALL REDUCTION IN SIZE/VOLUME IN THE TREATMENT OF SLOW FLOW VASCULAR MALFORMATIONS |