Curcumin Oral Gel Therapy in Patients Diagnosed with Oral Submucous Fibrosis

Assessing The Effect Of Curcumin On The Oral Mucosal Cytomorphometry And Candidal Species Specificity In Oral Submucous Fibrosis Patients- A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/097319

Enrollment

Registered

2025-11-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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 longa extract rhizome: Curcumin Intervention2: Curcumin longa extract - rhizome: Type of Intervention: Topical phytotherapeutic agent Dosage / Strength: Curcumin gel 2% (commer

Eligibility

Inclusion criteria

Inclusion criteria: 1.Participants wiiling to participate and provide written informed consent 2.Participants who are diagnosed clinically with oral submucous fibrosis. 3. Patients not on any topical or systemic treatment for OSMF in the past 3 months

Exclusion criteria

Exclusion criteria: 1.Patients with systemic diseases that may affect healing or response. 2.Individuals with other OPMD or neoplasm. 3.Patients with known allergy or hypersensitivity to turmeric or curcumin. 4.Individuals with habit cessation less than 3 months (to avoid confounding from recent abstinence). 5.Pregnant or lactating women. 6.Patients currently receiving antioxidants, steroids, or immunomodulatory therapy

Design outcomes

Primary

Measure	Time frame
1.Change in oral mucosal cytomorphometric parameters (cell diameter, nuclear diameter, CD:ND ratio) in OSMF patients receiving standard treatment alone and those receiving standard treatment with curcumin oral gel; healthy controls will provide baseline reference values only 2. Change in candidal species specificity and CFU/mL between the two OSMF groups and health control.(2) Change in candidal species specificity and CFU/mL between the two OSMF groups from baseline to 2 months. Time Frame: Baseline and 2 months for OSMF groups; baseline only for healthy controls(2) Change in candidal species specificity and CFU/mL between the two OSMF groups. Timepoint: 1.Change in oral mucosal cytomorphometric parameters (cell diameter, nuclear diameter, CD:ND ratio) in OSMF patients receiving standard treatment alone and those receiving standard treatment with curcumin oral gel; healthy controls will provide baseline reference values only 2. Change in candidal species specificity and CFU/mL between the two OSMF groups and health control.(2) Change in candidal species specificity and CFU/mL between the two OSMF groups from baseline to 2 months. Time Frame: Baseline and 2 months for OSMF groups; baseline only for healthy controls(2) Change in candidal species specificity and CFU/mL between the two OSMF groups.	—

Measure

Time frame

1.Change in oral mucosal cytomorphometric parameters (cell diameter, nuclear diameter, CD:ND ratio) in OSMF patients receiving standard treatment alone and those receiving standard treatment with curcumin oral gel; healthy controls will provide baseline reference values only 2. Change in candidal species specificity and CFU/mL between the two OSMF groups and health control.(2) Change in candidal species specificity and CFU/mL between the two OSMF groups from baseline to 2 months. Time Frame: Baseline and 2 months for OSMF groups; baseline only for healthy controls(2) Change in candidal species specificity and CFU/mL between the two OSMF groups. Timepoint: 1.Change in oral mucosal cytomorphometric parameters (cell diameter, nuclear diameter, CD:ND ratio) in OSMF patients receiving standard treatment alone and those receiving standard treatment with curcumin oral gel; healthy controls will provide baseline reference values only 2. Change in candidal species specificity and CFU/mL between the two OSMF groups and health control.(2) Change in candidal species specificity and CFU/mL between the two OSMF groups from baseline to 2 months. Time Frame: Baseline and 2 months for OSMF groups; baseline only for healthy controls(2) Change in candidal species specificity and CFU/mL between the two OSMF groups.

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Secondary

Measure	Time frame
To compare the reduction in micronuclei frequency in exfoliated epithelial cells between OSMF patients receiving standard treatment alone and those receiving standard plus curcumin therapy. To assess the change in candidal load and species variation among OSMF groups after 2 months of treatment. To monitor and record any adverse effects or compliance issues related to curcumin gel use. To use healthy controls as baseline reference values for cytomorphometric and candidal parametersTimepoint: Baseline to Two months	—

Measure

Time frame

To compare the reduction in micronuclei frequency in exfoliated epithelial cells between OSMF patients receiving standard treatment alone and those receiving standard plus curcumin therapy. To assess the change in candidal load and species variation among OSMF groups after 2 months of treatment. To monitor and record any adverse effects or compliance issues related to curcumin gel use. To use healthy controls as baseline reference values for cytomorphometric and candidal parametersTimepoint: Baseline to Two months

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Countries

India

Contacts

Public ContactDr Shubhangi Bagdey

Ranjeet Deshmukh Dental College and Research Centre

drshubhanibagdey@gmail.com9822797145

Outcome results

None listed

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