drugset / Trial / NCT04476420

Comparative Effect of Nigella Sativa and Conventional Management for OSMF

NCT04476420

Phase 3 Completed 39 enrolled Ziauddin University
RandomizedParallel-groupOpen-labelTreatment

Summary

Oral submucous fibrosis (OSMF) is a potentially malignant condition mainly characterized by inflammation and fibrosis of the submucosal tissues leading to marked rigidity and reduced opening of the jaws. OSMF has a multifactorial etiology but areca nut consumption is considered to be the most consistent factor in its pathogenesis. There is no definitive treatment available for treating OSMF. Conventional management involves physiotherapy exercises and treating the disease with certain medications such as steroids and homeopathic medications.

Timeline

Start
2021-02-11
Primary completion
2021-09-30
Completion
2021-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Nigella Sativa Oil Traditional medicine (herbal / TCM) 1 ml Topical
Comparator betamethasone valerate Small molecule 0.5 ml Topical