Correlation analysis of curcumin gel during treatment in patients with oral submucosal fibrosis

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2400088810

Enrollment

Unknown

Registered

2024-08-27

Start date

2024-09-01

Completion date

Unknown

Last updated

2024-09-09

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

control group:Triamcinolone acetate injection therapy

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

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) In line with the diagnostic criteria for Oral Submucosal fibrosis (Trial draft) Cause: The subjects had a history of chewing betel nut. Symptoms: burning of the oral mucosa, pain from eating irritating food, blisters on the mucosa of the soft palate, blisters bursting and forming small ulcers, impaired taste, tongue movement disorders, difficulty swallowing and restricted mouth opening. Signs: The focal or whole oral mucosa is grayish white, the mucosa is rough like leather, there are fiber lines in the inferior pterygocollar ligament area and the soft palate, the lingual papilla is atrophic, and the mouth opening is small.) Or study subjects with pathological diagnosis of OSF; (2) Age 18-60 years old; (3) Those who have not used immunomodulators or hormone drugs within three months. (4) Voluntarily participate in and sign informed consent, which mainly includes informed consent for disease examination methods and auxiliary treatment programs.

Exclusion criteria

Exclusion criteria: (1) Allergic to curcumin or other gel ingredients; (2) oral mucosa with malignant diseases such as cancerous ulcers (3) pregnant and lactating women; (4) People with mental illness or cognitive impairment; (5) Those who cannot take medication as prescribed by the doctor and return to the doctor on time; (6) Suffering from other local or systemic diseases.

Design outcomes

Primary

Measure	Time frame
Mucosal texture score;	—

Secondary

Measure	Time frame
mouth opening;Mucosal pain index;Mucosal color score;	—

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 4, 2026