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new tablet to treat burning sensation and stiffness of mouth

Colchicine as a Therapeutic Drug in the Management of Oral Submucous Fibrosis - A Randomized Clinical Trail

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/10/028680
Enrollment
30
Registered
2020-10-28
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: tablet colchicine (Goutnil) : dose - o.5mg
frequency - twice daily
route of administration - oral route
duration of therapy - for 3 months Control Intervention1: dexamethasone (Dexona) hyaluronidase (Hynidase) lignocaine HCl: dose - dexamethanose : 2ml, hyaluronidae : 1500 IU, lignocaine HCL : 2ml
frequency - weekly twice
route of administration - submucosal intralesional injection
duration of therapy - 1month

Sponsors

SVM Mounika
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with clinically diagnosed oral sub mucous fibrosis. 2. Patients who are ready to accept regular follow up protocol. 3. Patients willing to participate in the study

Exclusion criteria

Exclusion criteria: 1. patients with stage - III OSMF 2. Patients already receiving other treatment for OSMF 3. Pregnant Patients 4. Patient receiving immunosuppressant drugs 5. Patients with difficulty in mouth opening due to reasons other than OSMFas in pericoronitis, TMJ disorders 6. Patients having fibrotic lesions other than OSMF

Design outcomes

Primary

MeasureTime frame
- To clinically determine the efficacy of colchicine as monotherapy in OSMF patientsTimepoint: baseline, 3months, 6months

Secondary

MeasureTime frame
to measure the improvement in burning sensation, mouth opening, cheek flexibility, tongue protrusion in patients with osmf who are under colchicine treatmentTimepoint: baseline, 3months, 6months

Countries

India

Contacts

Public ContactSVMMOUNIKA

narayana dental college and hospital

rmannae@rediffmail.com9704014747

Outcome results

None listed

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