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Using Curcumin Gel, Lycopene, and Support Messages to help treat Oral precancerous condition in People Quitting Tobacco

Effectiveness of curcumin gel, lycopene antioxidant along with tobacco cessation counselling and daily text messaging in the management of oral submucous fibrosis: a randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/06/088392
Enrollment
50
Registered
2025-06-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Interventions

Intervention1: Curcumin gel: Curcuma oral gel containing curcuma longa extract (Rhizome), Which is available commercially under the brand name of curenext oral gel 50gm. This gel will be applied topi

Sponsors

Dr Priyanka D
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subjects aged 18-65 years Subjects with clinically diagnosed oral submucous fibrosis stage II and Stage III mouth opening.

Exclusion criteria

Exclusion criteria: Subjects with other oral lesions or condition along with OSMF Subjects who have undergone any treatment earlier for OSMF History of hypersensitivity to curcumin/ lycopene. Subjects with other debilitating diseases like diabetes, hypothyroidism, hypertension, renal disorder and other autoimmune diseases etc. OSMF subjects with malignant transformation Subjects with grade I, II, III tooth mobility Subjects with partial and complete edentulous. Subjects with any TMJ dysfunction Pregnant women and lactating mothers.

Design outcomes

Primary

MeasureTime frame
Mouth opening Burning sensation Timepoint: Baseline, 3weeks, 6weeks and 12 weeks

Secondary

MeasureTime frame
Improvement in Mouth opening Burning sensation Tongue protrusion Cheek flexibilityTimepoint: Baseline, 3 weeks, 6 weeks & 12 weeks

Countries

India

Contacts

Public ContactDr Priyanka D

Government Dental College and Research Institute Bangalore

docyashpcd@gmail.com9743055946

Outcome results

None listed

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