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treatment of oral submucous fibrosis

Comparison of efficacy of Lycopene and Xantinol Nicotinate in the management of patients with OSMF: A Randomized Clinical Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/103654
Enrollment
50
Registered
2026-02-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: K135- Oral submucous fibrosis Health Condition 2: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere

Interventions

Intervention1: Xantinol nicotine: Vasodilator from Pentoxyphylline GROUP Intervention2: Xantinol nicotinate: 1)Drug name- Xntinol nicotinate injection(vasodilator from Pentoxyphylline group) 2)dose -2

Sponsors

OTHER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients of either gender aged between 18-45 years. 2)Consumption of areca nut and its products. 3)Exhibiting signs and symptoms of OSMF. 4)Patients with no history of any treatment for Oral submucous fibrosis in the past 6 months. 5)Patients willing to participate and ready for regular follow-ups. 6)Patients willing to quit habits

Exclusion criteria

Exclusion criteria: 1)Patients with other mucosal disorders with clinical features same as oral submucous fibrosis. 2)Patients on anticoagulants. 3)Pregnant patients. 4)History of recent myocardial infarction, cerebrovascular accidents, severely compromised cardiac function, and caffeine or theophylline intolerance. 5)Patients hypersensitive to Xantinol nicotinate

Design outcomes

Primary

MeasureTime frame
Mouth opening(interincisinal distance)Timepoint: 2 months (every 1 weeks follow up)—

Secondary

MeasureTime frame
burning sensation (VAS score)Timepoint: 2 months(every 1 weeks follow up)—

Countries

India

Contacts

Public ContactAMIT TIWARI

peoples college of dental sciences and research center bhopal

6jainpalak@gmail.com8461868282

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026