Evaluation of Therapeutic Potential of Pirfenidone by Protein and Gene Expression Profiling in Oral Submucous Fibrosis induced by Tobacco and Arecanut Formulations: A Randomized Controlled Trial - PFD OSMF

Indian Council of Medical Research0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年5月1日

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•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.

•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

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