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Testing Four Medicines for Treating Stage II Oral Submucous Fibrosis: A Patient Study

Evaluation Of Isoxpurine, Pentoxifylline, Colchicine And Lycopene As Therapeutic Agents In The Management Of Oral Submucous Fibrosis: A Randomized, Double-Blind Clinical Trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/102937
Enrollment
160
Registered
2026-02-04
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: - Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: ISOXSUPRINE, PENTOXIFYLLINE, COLCHICINE: Isoxpurine: 100 mg orally, twice a day for 3 months. Pentoxifylline: 400 mg orally, twice a day for 3 months. Colchicine: 0.5 mg orally, twic

Sponsors

Preeti Parameswaran Nair
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 OSMF diagnosed as Grade II clinically- (More C et al classification of OSMF) 2 Adults aged 18 to 65 years diagnosed with oral submucous fibrosis Gd II. 3 Patients who have not received any treatment for oral submucous fibrosis in the last three months. Patients who willing to quit the usage of areca nut and tobacco

Exclusion criteria

Exclusion criteria: 1 Patients with a history of allergic reactions to the study medications. 2 Pregnant or breastfeeding women. 3 Patients with severe systemic diseases or malignancies. 4 Patients with other white or red lesions of the oral mucosa.

Design outcomes

Primary

MeasureTime frame
Interincisal Opening- measured in millimeters at each visit Pain and burning sensation Assessed using a visual analong scale (VAS) Timepoint: baeline, 1 month, 2 months, 3 months

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Preeti Parameswaran Nair

PEOPLES COLLEGE OF DENTAL SCIENCES AND RESEARCH CENTRE BHOPAL

nairpp1869@gmail.com09425304068

Outcome results

None listed

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