The effect of oral methylene blue in the treatment of patients with thermal burns

The effect of oral methylene blue in the treatment of patients with thermal burns of =30% body surface area: a pilot study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20241116063729N2

Enrollment

Registered

2025-06-25

Start date

2025-07-01

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Patients with thermal burns involving more than 30% of total body surface area (TBSA). Burns involving 30-39% of body surface with 10-19% third degree burns

Interventions

Intervention 1: Intervention group: Oral treatment with methylene blue dissolved in 200 mL of milk daily, administered as two sachets of 30 mg each (60 mg per day) for 8 weeks. Intervention 2: Control

Eligibility

Sex/Gender

All

Age

16 Years to 50 Years

Inclusion criteria

Inclusion criteria: Willingness to participate in the study and complete the informed consent form Patients with burns covering more than 30% of their body Body mass index (BMI) between 18 and 35 No use of medications that may interfere with wound healing, such as corticosteroids, immunosuppressants, and cytotoxic agents Let me know if you need any modifications! Free from underlying conditions that may hinder recovery, including cancers, vasculitis, kidney or liver failure, and heart failure

Exclusion criteria

Exclusion criteria: Withdrawal of consent and unwillingness to continue participation Presence of an actively infected wound requiring antibiotic treatment Gangrene necessitating amputation

Design outcomes

Primary

Measure	Time frame
Comparison of wound size reduction between the intervention and control groups. Timepoint: From baseline to week 8 of treatment. Method of measurement: Assessment of wound size reduction using a digital camera.;Re-epithelialization rate. Timepoint: From baseline to week 8 of treatment. Method of measurement: Direct observation.	—

Secondary

Measure	Time frame
Inflammation level. Timepoint: From baseline to week 8 of treatment. Method of measurement: thermal camera.;HSBS-B score (Hydration, Sensation, Bleeding, and Scar – Burns). Timepoint: From baseline to week 8 of treatment. Method of measurement: Questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactOmid Yazarlou

Mashhad University of Medical Sciences

YazarlouOM@mums.ac.ir0985138400001

Outcome results

None listed

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