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Efficacy of antioxidants in the management of Oral submucous fibrosis

Efficacy of Lycopene versus Lycopene and Curcumin in the management of Oral submucous fibrosis a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013285
Enrollment
68
Registered
2018-04-16
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- 50 Oral Submucous Fibrosis Patients

Interventions

Intervention1: lycopene capsules: 2000mcg orally twice daily orally for three months Control Intervention1: Combined therapy with lycopene and curcumin: 2000mcg lycopene twice daily and circuit h 400m

Sponsors

Narayana Dental College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 25 Oral Submucous Fibrosis patients to be put on Systemic lycopene therapy alone 25 Oral Submucous Fibrosis patients to be put on a combination of Lycopene and Curcumin

Exclusion criteria

Exclusion criteria: Hypersensitivity to Curcumin and /or lycopene Patients with Gall Stones and other Gastrointestinal disorders Patients with Fibrotic lesions other than Oral Sub Mucous Fibrosis Patients receiving any other medications

Design outcomes

Primary

MeasureTime frame
Relief from Burning Sensation Improved Interincisal Mouth Opening Cheek Mucosa Flexibility ImprovementTimepoint: at end of first month and at the end of three months after starting the therapy—

Secondary

MeasureTime frame
Relief from Burning Sensation Timepoint: 3 Months—

Countries

India

Contacts

Public ContactKannan

Narayana Dental College and Hospital

dr.pulim@gmail.com8500758749

Outcome results

None listed

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