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

Pirfenidone as an antifibrotic agent in the treatment of oral submucous fibrosis-A Pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/023844
Enrollment
15
Registered
2020-03-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K135- Oral submucous fibrosis

Interventions

Intervention1: Pirfenidone Drug: Pirfenidone Drug 200mg thrice daily for 21 days Control Intervention1: NIL: NIL

Sponsors

Dr Akshaya S R
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1.Burning sensation is recorded using a visual analog scale. Timepoint: 21 days

Secondary

MeasureTime frame
Mouth opening (Inter incisal distance) scoring was adoptedTimepoint: 21 days

Countries

India

Contacts

Public ContactDr Akshaya S R

Tamilnadu Dr. MGR medical university

sivansathishmfds@yahoo.co.in9344544536

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026