Health Condition 1: K135- Oral submucous fibrosis
Conditions
Interventions
Intervention1: Tablet Pirfenidone: Tablet Pirfenidone 200 mg, twice daily, for a period of Six months
Control Intervention1: Capsule Curcumin 100 mg: Capsule Curcumin 100 mg, twice daily, for a period
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participants, clinically and histo-pathologically diagnosed for having Oral Submucous Fibrosis irrespective of age, gender & duration of the lesion. 2. Participants irrespective of their residing areas, socio-economic status, religion, caste and creed. 3. Participants clinically and histo-pathologically diagnosed for having Oral Submucous Fibrosis associated with any arecanut or its product related habit irrespective of duration. 4. No evidence of dysplasia or malignancy on histo-pathological examination. 5. Participants, who have discontinued the deleterious habits containing arecanut and tobacco, after counselling session/s, will be included in the present study.
Exclusion criteria
Exclusion criteria: 1.Participants with any type of systemic disease, both in past & present. 2. Participants who had undergone any type of treatment for Oral Sub mucous fibrosis. 3. Cigarette smoking within 28 days before the start of treatment or unwilling to avoid tobacco products throughout the study 4. Clinical diagnosis of any connective tissue disease, including but not limited to scleroderma, systemic lupus erythematosus, dermatomyositis, rheumatoid arthritis. 5. History of hepatic impairment, renal impairment, end stage renal or hepatic disease 6. Any history of malignancy in other body organs or treated for the same by surgery, radiotherapy and chemotherapy. 7.Pregnant and lactating mothers or intention to become pregnant during the study. 8.History of unstable or deteriorating cardiac or pulmonary disease, renal or liver disease 9.History of hypersensitivity to PFD and other antioxidants, allergy, photosensitivity reaction 10.Stage OSMF 4 A & B participants 11. Participants unwilling to give written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in the Clinical Parameters - mouth opening, tongue protrusion, cheek flexibility anddecreased burning sensation. 2. Decreased levels of pro-inflammatory Cytokinesand fibrosis, transcription factors, genes responsible for fibrogenesis, proliferation, metastasis evident from gene expression and protein analysis during pre and post treatment phase.Timepoint: 0, 3 and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in quality of lifeTimepoint: 0, 3 and 6 months | — |
Countries
India
Contacts
Public ContactDr Deepa J Patil
K.M Shah Dental College and Hospital, Sumandeep Vidyapeeth Deemed to be University
Outcome results
None listed