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USE OF CURCUMIN IN TREATMENT OF ORAL SUBMUCOUS FIBROSIS: A HOSPITAL BASED STUDY

EFFICACY OF CURCUMIN AS AN ADJUNCT TO INTRALESIONAL DEXAMETHASONE WITH HYALURONIDASE IN TREATMENT OF ORAL SUBMUCOUS FIBROSIS: A RANDOMIZED CONTROLLED TRIAL

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/05/019451
Enrollment
34
Registered
2019-05-30
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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: Test Group: 1. Intralesional Dexamethasone 8mg twice a week for first 2 weeks followed by Intralesional Dexamethasone 8mg plus Hyaluronidase 1500IU twice a week for next 4 weeks 2.Capsu

Sponsors

Dr Sagar Adhikari
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Grade 1 to Grade 4A Oral Submucous Fibrosis as per the grading system provided by Kerr et al which are as follows: Grade 1: Mild: Any features of the disease triad for OSF (burning, depappillation, blanching or leathery mucosa) may be reported- and inter-incisal opening > 35mm Grade 2: Moderate: Above features of OSF + interincisal opening 20-35mm Grade 3- Severe: Above features of OSF + interincisal opening Grade 4A- OSF with other potentially malignant disorder on clinical examination

Exclusion criteria

Exclusion criteria: 1. Patient unwilling to participate or not giving consent. 2. Patients with debilitating diseases such as Carcinoma, patients contraindicated for steroids 3. Patients with other mucosal disorders with clinical features same as OSF (such as: systemic sclerosis, amyloidosis, iron deficiency anemia, trismus due to Temporomandibular Joint Dysfunction, pericoronitis, space infection, history of surgery or trauma, radiation therapy.) 4. Patient who were under treatment or have had already undergone treatment for OSF 5. Patients with history of hypersensitivity to Hyaluronidase

Design outcomes

Primary

MeasureTime frame
Assess efficacy of Curcumin as an adjunct to intralesional dexamethasone and hyaluronidase to treat Oral Submucous FibrosisTimepoint: 6, 8, 12 weeks—

Secondary

MeasureTime frame
1. Measurement of the difference in interincisal mouth opening in test and control group 2. Measurement of the difference in cheek flexibility and tongue protrusion in test and control group. 3. Comparison of the VAS scores of burning sensation with hot and food among test and control group. Timepoint: 6, 8, 12 weeks—

Countries

Nepal

Contacts

Public ContactDr Sagar Adhikari

BPKIHS, Dharan

jyotsna.rimal@bpkihs.edu009779852059258

Outcome results

None listed

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