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Exploration of the Clinical Efficacy of Curcumin Gel in Patients with Oral Submucous Fibrosis (OSF)

Exploring a New Treatment Strategy for Oral Submucous Fibrosis: Investigation into Curcumin Oral Delivery Forms

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092888
Enrollment
Unknown
Registered
2024-11-25
Start date
2022-07-21
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

oral submucous fibrosis(OSF)

Interventions

Treated group:Triamcinolone acetate injection treatment, curcumin gel local application adjuvant treatment

Sponsors

Hunan Xiangya School of Stomatology, Central South University (Xiangya Stomatological Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Patients who either conform to the Diagnostic Criteria for Oral Submucosal Fibrosis (Full details are given in Appendix A) or have been pathologically diagnosed with OSF. (2) Individuals aged between 18 to 60 years. (3) Participants who have refrained from using immunomodulatory agents or hormonal medications for a period of three months prior to the study.

Exclusion criteria

Exclusion criteria: (1) Individuals with allergies to curcumin or any other gel components. (2) Patients suffering from malignant oral mucosa diseases, such as cancerous ulcers. (3) Pregnant and breastfeeding women. (4) Individuals with mental illnesses or cognitive impairments that may affect their ability to comply with the study protocol. (5) Patients who are unlikely to adhere to the medical advice or to attend follow-up appointments as scheduled. (6) Patients with other localized or systemic conditions that could interfere with the study outcomes or participant safety.

Design outcomes

Primary

MeasureTime frame
Interincisor distance;Scores of mucosal colors;Scores of mucosal textures;

Secondary

MeasureTime frame
Pain index of mucosa;

Countries

China

Contacts

Public ContactWang Yuehong

Hunan Xiangya School of Stomatology, Central South University (Xiangya Stomatological Hospital)

wangyuehong1999@csu.edu.cn+86 186 2753 3303

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026