A study on the effects of two drugs, silymarin and curcumin in patients with potentially malignant disorder involving mouth

Phase 3

• Conditions: Health Condition 1: K135- Oral submucous fibrosis

• Registration Number: CTRI/2021/01/030470
• Lead Sponsor: il

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients with clinical features of Oral submucous Fibrosis (OSMF) such as blanching, palpable vertical fibrotic bands and reduction in the mouth opening

2. No histopathological evidence of dysplastic or malignant changes

3. Patients who are willing to quit the habit and come for regular follow up for 6 months

4. Stage 2 and Stage 3 patients based on Khanna and Andrade functional staging (Mouth opening >15 mm and <35 mm)

Exclusion Criteria

1. Patients who have not given informed consent

2. Patients who have undergone prior treatment for OSMF

3. Stage I and Stage IV OSMF (Mouth opening â?? >35mm and <15mm)

4. Patients planned for surgical management

5. Patients with no history of cardiac, renal, pulmonary and hepatic diseases

6. History of hypersensitivity to curcumin or silymarin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of burning sensation, Mouth opening measurementTimepoint: 1,3,6 months

Secondary Outcome Measures

Name	Time	Method
Tongue protrusion measurementTimepoint: 1,3,6 months