Skip to content

Effect of two drugs in treatment of oral submucous fibrosis

Clinical correlation and expression of Zeb1, Twist and E-cadherin in patients with oral submucous fibrosis and oral cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/09/009674
Enrollment
45
Registered
2017-09-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- oral submucous fibrosis

Interventions

Intervention1: Group A Tablet Curcumin and Piperine 300 mg: 300 mg tablet was administered orally twice daily for 6 months Intervention2: Group B Tablet Lycopene 16 mg: 16 mg tablet was administered o

Sponsors

Maulana Azad Institute of Dental Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Clinically & Histopatholically proven cases of OSMF a positive history of chewing areca nut, tobacco, betel quid, smoking and alcohol difficulty in swallowing, chewing and burning sensation on eating spicy foods restricted mouth opening and changes in the oral mucous membrane including the presence of palpable vertical fibrous bands, stiffness and blanching.

Exclusion criteria

Exclusion criteria: those who are not willing to participate patients who are already undertaking some treatment for existing potentially malignant oral disorder patients with severe systemic disorder

Design outcomes

Primary

MeasureTime frame
evaluation of burning sensation score, mouth opening, tongue protrusion and cheek flexibility between groups and within groupTimepoint: patients were assessed clinically every 4 weeks for 9 months

Secondary

MeasureTime frame
Reporting of malignant transformation over period of 9 monthsTimepoint: patients were assessed clinically every 4 weeks for 9 months. in case of any suspicion biopsy was done

Countries

India

Contacts

Public ContactDr Anshul Mahajan

Maulana Azad Institute of Dental Sciences

drsunitagupta@yahoo.com9654700955

Outcome results

None listed

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