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A study on the role of traditional drug based dressings in the treatment of skin wounds produced in breast cancer patients undergoing radiotherapy

Evaluation of clinical efficacy and safety of Acalypha indica impregnated thin film on radiation induced dermatitis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/11/029311
Enrollment
98
Registered
2020-11-24
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Health Condition 1: C508- Malignant neoplasm of overlappingsites of breast

Interventions

Intervention1: Wound dressing thin film impregnated with 5% Acalypha indica: 5% Acalypha indica, Applied topically over radiation dermatitis wounds on alternate days for 14 days Control Intervention1:

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patient willing to give written informed consent form 2. Newly diagnosed with non metastatic breast cancer and undergoing adjuvant radiation for breast cancer who develop grade III radiation therapy induced moist desquamation

Exclusion criteria

Exclusion criteria: 1.Patient unwilling to take part in study 2.Patients with contraindications for Radiation therapy 3.Patients with radiation skin reactions of severity less than Grade III 4.Patients with pre existing skin conditions such as psoriasis, eczema, or connective tissue disorders or history of allergy to components used in trial dressings 5.Patients on steroids or immunosuppressant therapy

Design outcomes

Primary

MeasureTime frame
To assess tolerance of Acalypha indica impregnated thin film on radiated tissue Timepoint: 4th to 6th week of radiation treatment for each patient.

Secondary

MeasureTime frame
To assess wound healing capacity of Acalypha indica impregnated thin film on radiation induced dermatitis wounds with respect to time taken for complete wound healing in comparison to gentian violet topical application. To assess improvement in quality of life of patientsTimepoint: Upto 6 months after completion of radiation protocol of last recruited patient

Countries

India

Contacts

Public ContactJJayasutha

Sri Ramachandra Institute of Higher Education and Research (Deemed University)

dr_satishsrinivas@sriramachandra.edu.in9884780974

Outcome results

None listed

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