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Study to evaluate the effectiveness of blueberry emulgel in reducing oral leukoplakia lesions in patients with oral leukoplakia

Effectiveness of Topical Anthocyanin-Rich Blueberry Chitosan Nanoemulgel in management of Oral Leukoplakia: A Clinical Trial - BLUE-OL Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/07/113626
Enrollment
34
Registered
2026-07-07
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Health Condition 1: K132- Leukoplakia and other disturbancesof oral epithelium, including tongue

Interventions

Intervention1: Anthocyanin Rich Blueberry Chitosan Nanoemulgel: Topical application of anthocyanin rich blueberry chitosan nanoemulgel over the oral leukoplakia lesion twice daily for 30 days Control

Sponsors

Saveetha Dental College and Hospitals
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Oral leukoplakia Van der Waal Stage I and Stage II lesions. Patients who have not undergone any previous treatment for oral leukoplakia. Patients willing to provide written informed consent. Patients willing to attend follow up visits at baseline, 15th day and 30th day.

Exclusion criteria

Exclusion criteria: Oral leukoplakia Van der Waal Stage III and Stage IV lesions. Patients with other oral potentially malignant disorders. Patients with histopathological evidence of severe dysplasia or malignancy. Pregnant and lactating women. Patients allergic to anthocyanin, chitosan or tretinoin. Patients with uncontrolled systemic disease or immunocompromised status.

Design outcomes

Primary

MeasureTime frame
Reduction in lesion size of oral leukoplakia following treatment with anthocyanin rich blueberry chitosan nanoemulgelTimepoint: Baseline, 15th day, 30th day

Secondary

MeasureTime frame
Assessment of clinical improvement in oral leukoplakia lesions and evaluation of adverse effects associated with treatment. Timepoint: Baseline, 15th day, 30th day

Countries

India

Contacts

Public ContactDr Sreedevi Dharman

Saveetha Dental College and Hospitals

sreedevi@saveetha.com9841009003

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026