sefulness of a new medicine -pirfenidone in oral fibrosis due to Arecanut and tobacco use

Not Applicable

Conditions: Health Condition 1: K135- Oral submucous fibrosis

Registration Number: CTRI/2023/04/051723

Lead Sponsor: Indian Council of Medical Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in the Clinical Parameters - mouth opening, tongue protrusion, cheek flexibility anddecreased burning sensation. <br/ ><br>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 Outcome Measures