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

Comparative analysis of intralesional sclerotherapy with sodium tetradecyl sulphate versus bleomycin in the management of slow flow vascular malformations

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/05/053122

Enrollment

Registered

2023-05-25

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Q279- Congenital malformation of peripheral vascular system, unspecified

Interventions

Intervention1: 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

2nd dose to be given 4-6 weeks after the 1st dose Control Intervention1: BLEOMYCIN: BLEOMYCIN IS A SCLEROSING AGENT USED IN THE TREATMENT OF SLOW FLOW VASCULAR MALFORMATIONS, IT IS ALSO AN ANTI-CANCER

2nd dose to be given 4-6 weeks after the 1st dose

Eligibility

Inclusion criteria

Inclusion criteria: ALL PATIENTS HAVING SLOW FLOW VASCULAR MALFORMATIONS AND REQUIRING TREATMENT AND GIVING CONSENT FOR SCLEROTHERAPY

Exclusion criteria

Exclusion criteria: ALL PATIENTS HAVING SLOW FLOW VASCULAR MALFORMATIONS NOT REQUIRING TREATMENT OR NOT GIVING CONSENT FOR SCLEROTHERAPY

Design outcomes

Primary

Measure	Time frame
OVERALL REDUCTION IN SIZE/VOLUME AND VASCULARITY/FLOW RATE AFTER INTRA-LESIONAL SCLEROTHERAPY WITH SODIUM TETRADECYL SULFATE AND BLEOMYCINTimepoint: BASELINE, THEN 4-6 WEEKS AFTER FIRST SITTING, THEN 4-6 WEEKS AFTER SECOND SITTING	—

Secondary

Measure	Time frame
SURGICAL OUTCOME AND THE EASE OF OPERABILITY IN CASE OPERATEDTimepoint: 24 MONTHS	—

Countries

India

Contacts

Public ContactDR SAIFULLAH KHALID

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

saif2k2@gmail.com9897218098

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026