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Lycopene improves clinical and reduces harmful radicals in Oral submucous fibrosis patients

Effect of Lycopene on clinical and salivary biochemical parameters in Oral submucous fibrosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009488
Enrollment
30
Registered
2017-08-24
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- Patients suffering from OSMF were included All the patients showed decreased signs and symptoms Salivary oxidative stress was reduced too

Interventions

Intervention1: Lycopene: Given orally at a dose of 16 mg per day in two divided doses for two months Control Intervention1: not applicable: single arm

Sponsors

Self
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: patients with clinically diagnosed oral submucous fibrosis

Exclusion criteria

Exclusion criteria: 1. Patient on any medications for OSMF 2. Patient with any other apparent systemic disease 3. Patient with other oral potentially malignant disorders 4. Patient with any oral malignant changes.

Design outcomes

Primary

MeasureTime frame
Increased oxidative stress in OSMF prior to treatment i.e. Pretreatment increased salivary malondialdehyde and decreased superoxide dismutase. Decreased oxidative stress after therapy i.e. post treatment decreased salivary malondialdehyde and increased superoxide dismutase.Timepoint: After 2 months—

Secondary

MeasureTime frame
Decreased clinical signs and symptoms after therapy with lycopene viz., mouth opening, burning sensation, tongue protrusionTimepoint: after 2 months—

Countries

India

Contacts

Public ContactPriya Anil Bhagde

Joint director and Professor

drsuresh.barpande@gmail.com9422205399

Outcome results

None listed

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