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Evaluation of efficacy of triphala in patients with oral submucous fibrosis: A Randomized Controlled Trial.

Comparative evaluation of efficacy of triphala with lycopene in patients with oral submucous fibrosis: A Randomized Controlled Trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045425
Enrollment
60
Registered
2022-09-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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

None listed

Sponsors

Dr Komal Deotale
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with stage 2 OSMF with i.e mouth opening between 25mm-35mm according to Chandramani More Classification

Exclusion criteria

Exclusion criteria: 1. Patients with other intra oral lesions. 2. Patients with known hypersensitivity to triphala. 3. Patients with prior treatment for OSMF.

Design outcomes

Primary

MeasureTime frame
Triphala is efficacious in management of Oral Submucous Fibrosis in terms of increase in mouth opening, reduction in burning sensation and increase in tongue protrusion which will be measured and recorded at baseline, 1st, 2nd and 3rd month. Timepoint: Pre-operative Burning Sensation, Interincisal Mouth Opening and Tongue Protrusion will be measured. These clinical parameters will be measured and recorded at baseline, 1st , 2nd , and 3rd month.

Secondary

MeasureTime frame
Triphala is as efficacious as lycopene in management of Oral Submucous Fibrosis in terms of increase in mouth opening, increase in tongue protrusion and reduction in burning sensation.Timepoint: All the parameters will be recorded at baseline, at every 15th day and after 3 months

Countries

India

Contacts

Public ContactDr Ashish lanjekar

Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital

ashish.lanjekar@sdk-dentalcollege.edu.in9595052481

Outcome results

None listed

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