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To find out if a new drug in combination with the present drug is better than the present drug given alone for treatment of Oral Sub mucous fibrosis.

Efficacy of topical curcumin in combination with topical steroid on clinical symptoms and on salivary levels of TNF-alpha and TIMP-1 in clinically diagnosed stage I and Stage II Oral Sub mucous Fibrosis â?? A randomized clinical trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/029859
Enrollment
50
Registered
2020-12-16
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: L948- Other specified localized connective tissue disorders

Interventions

Intervention1: Steroid: Topical intra-oral steroid paste, 0.1% oral gel (5gm), 3 times a day for 3 months. Intervention2: Curcumin: Topical intra-oral Curcumin gel, commercially available curcuma oral

Sponsors

Dr Neha Anil Patil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Clinical and functionally classified stage I and stage II OSMF (Oral Sub mucous Fibrosis) patients. 2. Age â?? 14- 45 yrs. 3. Patients not under any intervention for the same will be included.

Exclusion criteria

Exclusion criteria: 1. Clinical and functionally stage III, IV A, IV B and V OSMF patients. 2. Any other Oro-mucosal lesions/conditions 3. Patients who are under treatment for the OSMF 4. Diagnosed cases not ready for participation in the study 5. Patients suffering from medically compromised conditions. 6. Patients who are receiving or have received any form of therapy in the past six-month period will be excluded. 7. Children (less than 13 yrs) and pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
To study the efficacy of combination therapy over present monotherapy for treatment of Stage I and II Oral Submucous Fibrosis Patients.Timepoint: 1.5yrs—

Secondary

MeasureTime frame
To assess the change in the Quality of life of patients after treatment for Oral Submucous FibrosisTimepoint: 1.5 yrs—

Countries

India

Contacts

Public ContactDr Neha Anil Patil

MGM Institute of Health Sciences, Navi Mumbai

drkhandelwalpn@gmail.com

Outcome results

None listed

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