A clinical trial study-Use of oral colchicine in treatment of patients with oral submucous fibrosis

Effect of oral colchicine in oral submucous fibrosis-A clinical trial - CESMF

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/07/026322

Enrollment

Registered

2020-07-02

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

None listed

Interventions

Intervention1: 0.5mg oral colchicine: 0.5mg colchicine capsule orally twice a day for 3 month Control Intervention1: placebo: empty capsule as placebo orally twice a day for 3 months

Eligibility

Inclusion criteria

Inclusion criteria: Grade III patient â?? moderately advanced cases of OSMF (15 â?? 25mm) No other curative agent used

Exclusion criteria

Exclusion criteria: Medically compromised condition Pregnant and breastfeeding females Trismus due to any other reason such as pericoronitis, dental abscess Patients taking drugs that are CYP3A4&P-gp inhibitors like erythromycin, clarithromycin, fluconazole, verapamil, grapefruit juice and HIV drugs Allergy to prednisolone and colchicine

Design outcomes

Primary

Measure	Time frame
Increase in interincisal mouthopeningTimepoint: After 9 MONTH OF INTERVENTION	—

Secondary

Measure	Time frame
Efficacy of drugTimepoint: 9 months	—

Countries

India

Contacts

Public ContactDr Archana chandrakant Marlaplle

Govt.Dental college and Hospital Nagpur

gosavisr@gmail.com9766233335

Outcome results