Health Condition 1: K137- Other and unspecified lesions of oral mucosa
Conditions
Interventions
Intervention1: Tocofibro Capsule A Nutraceutical Antioxidant
Formulation containing Alpha-lipoic acid, Zinc (as
Zinc bisglycinate), Beta-carotene, Tocotrienols,
Lycopene, and Selenium.: Tocofibro c
Sponsors
Indoco Remedies Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult patients of either gender aged 18 years and above. 2.Patients with clinically diagnosed oral pre cancerous lesions including oral leukoplakia erythroplakia oral lichen planus or oral submucous fibrosis confirmed by clinical evaluation with or without histopathological confirmation. 3.Patients with lesions not requiring immediate surgical intervention at the time of screening. 4.Patients willing to provide written informed consent and comply with study procedures and scheduled follow up visits.
Exclusion criteria
Exclusion criteria: 1.Patients with clinical or histopathological evidence of oral malignancy. 2.Patients with oral submucous fibrosis who have received intralesional injections or undergone surgical treatment prior to screening. 3.Patients with advanced oral submucous fibrosis Stage 4 or inter incisal mouth opening less than 15 mm at screening. 4.Patients with other fibrotic diseases with oral manifestations or trismus due to causes other than oral submucous fibrosis. 5.Patients currently receiving systemic antioxidants corticosteroids or similar nutraceutical supplements that may interfere with the evaluation of the study product. 6.Patients with known hypersensitivity or intolerance to any component of Tocofibro. 7.Women known to be pregnant or lactating or planning to become pregnant during the study period. 8.Patients with any severe systemic illness or uncontrolled medical condition that in the opinion of the investigator may interfere with study participation or outcome assessment. 9.Participation in another clinical study within 3 months prior to screening. 10.Any other condition which in the opinion of the investigator would make the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in lesion size in square millimeters compared to baseline in patients with oral leukoplakia, erythroplakia, and oral lichen planus. 2.Change in inter incisal mouth opening in millimeters compared to baseline in patients with oral submucous fibrosis OSMF.Timepoint: 1.At Visit 2(Month 3) and Visit 3(Month 6) 2.At Visit 2(Month 3) and Visit 3(Month 6) | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage reduction in lesion size at Month 3 and Month 6 compared to baseline in patients with oral leukoplakia, erythroplakia, and oral lichen planus.Timepoint: From Day 0 (Baseline) to Month 3(Visit 2) and Month 6 (Visit 3);Percentage improvement in inter incisal mouth opening compared to baseline in patients with oral submucous fibrosis OSMF.Timepoint: From Day 0 (Baseline) to Month 3(Visit 2) and Month 6 (Visit 3);Change in patient reported pain and oral discomfort scores using VAS compared to baseline in patients with oral leukoplakia, erythroplakia, and oral lichen planus.Timepoint: From Day 0 (Baseline) to Month 3(Visit 2) and Month 6 (Visit 3);Change in patient reported burning sensation scores using VAS compared to baseline in patients with oral submucous fibrosis OSMF.Timepoint: From Day 0 (Baseline) to Month 3(Visit 2) and Month 6 (Visit 3);Proportion of patients with oral leukoplakia, erythroplakia, and oral lichen planus demonstrating clinical response compared to baseline.Timepoint: From Day 0 (Baseline) to Month 3(Visit 2) and Month 6 (Visit 3);Physician Global Assessment of Response PGA.Timepoint: From Day 0 (Baseline) to Month 3(Visit 2) and Month 6 (Visit 3);Incidence of adverse events AEs during the study.Timepoint: Up to Month 6 (Visit 3) End of study.;Incidence of serious adverse events SAEs during the study.Timepoint: Up to Month 6 (Visit 3) End of study.;Treatment discontinuations due to adverse events, if any.Timepoint: Up to Month 6 (Visit 3) End of study. | — |
Countries
India
Contacts
Public ContactDr Jayesh Sanmukhani
Indoco House, 166 CST Road, Santacruz (E)
Outcome results
None listed