A new drug Pirfenidone used in relieving the stiffness of the mouth caused by tobacco chewing

Not Applicable

Not yet recruiting

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

• Registration Number: CTRI/2020/03/023844
• Lead Sponsor: Dr Akshaya S R

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

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

Inclusion Criteria

1. Female and male with positive history of areca nut chewing in any form

2. Patients with clinically diagnosed Oral submucous fibrosis

3. Patients those who are willing to take part in the study

Exclusion Criteria

1. Patient with systemic disorders such as uncontrolled diabetes, Systemic hypertension, cardiac illness, liver disease, bleeding disorder, gastrointestinal disorder and renal disease.

2. Patients with TMJ disorders and other forms of trismus are excluded from the study

3. Those who had received previous treatment were excluded from the study

4. Patients who is under Fluvoxamine and ciprofloxacin are not included in the study

5.Patients who are smoking are not included in the study

6. Patients not willing to give up addiction habits of Gutka, Pan-Masala, tobacco, etc

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Burning sensation is recorded using a visual analog scale. <br/ ><br>Timepoint: 21 days

Secondary Outcome Measures

Name	Time	Method
Mouth opening (Inter incisal distance) scoring was adoptedTimepoint: 21 days