Comparison of effectiveness of two medicines(sodium tetradecyl sulphate versus bleomycin)in the non-operative management of slow flow vascular malformations by sclerotherapy

Phase 3

Not yet recruiting

• Conditions: Congenital malformation of peripheral vascular system, unspecified,

• Registration Number: CTRI/2023/05/053122
• Lead Sponsor: JAWAHARLAL NEHRU MEDICAL COLLEGE AND HOSPITAL JNMCH AMU ALIGARH UTTAR PRADESH

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-06
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

ALL PATIENTS HAVING SLOW FLOW VASCULAR MALFORMATIONS AND REQUIRING TREATMENT AND GIVING CONSENT FOR SCLEROTHERAPY.

Exclusion Criteria

ALL PATIENTS HAVING SLOW FLOW VASCULAR MALFORMATIONS NOT REQUIRING TREATMENT OR NOT GIVING CONSENT FOR SCLEROTHERAPY.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
SURGICAL OUTCOME AND THE EASE OF OPERABILITY IN CASE OPERATED	24 MONTHS

Trial Locations

Locations (1)

JAWAHARLAL NEHRU MEDICAL COLLEGE AND HOSPITAL (JNMCH), A.M.U., ALIGARH; 🇮🇳 Aligarh, UTTAR PRADESH, India

JAWAHARLAL NEHRU MEDICAL COLLEGE AND HOSPITAL (JNMCH), A.M.U., ALIGARH

🇮🇳Aligarh, UTTAR PRADESH, India

DR SAIFULLAH KHALID

Principal investigator

9897218098

saif2k2@gmail.com