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A PROSPECTIVE, COMPARATIVE, RANDOMIZED STUDY TO ASSESS THE EFFICACY AND SAFETY OF SNEC30 (CURCUMA LONGA) CAPSULES AND SNEC ORAL GEL TOPICAL APPLICATION IN THE TREATMENT OF ORAL SUBMUCOSAL FIBROSIS

A PROSPECTIVE, COMPARATIVE, RANDOMIZED STUDY TO ASSESS THE EFFICACY AND SAFETY OF SNEC30 (CURCUMA LONGA) IN THE TREATMENT OF ORAL SUBMUCOSAL FIBROSIS

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/02/011939
Enrollment
80
Registered
2018-02-16
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: null- ORAL SUBMUCOSAL FIBROSIS

Interventions

Intervention1: SNEC30 (Curcumin Therapy): Each 900 mg capsule contains:- SNEC30 (Curcuma Longa) Eq. to Curcuminoids â?¦. 30 mg Control Intervention1: Conventional treatment: Conventional treatment C

Sponsors

Arbro Pharmaceuticals Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient or his legally accepted representative is willing to give informed consent. 2. Patient is in the age range of 18-65 yrs. 3. Patient clinically diagnosed with OSF (diagnosed on the basis of reduction in interincisal distance on maximum mouth opening and palpable fibrous bands involving oral mucosa). 4. Patient is willing to discontinue the use of tobacco in any form or areca 1-month prior to the commencement of the treatment.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Reduction in burning sensation. Improvement in mouth opening. Timepoint: reduction in burning sensation and mouth opening will be checked at enrollment day , day 28, day 56 and day 84.

Secondary

MeasureTime frame
Safety and tolerability of the drug will be evaluated on the basis of occurrence / non-occurrence, type, frequency and duration of drug-related adverse reactionsTimepoint: Safety and tolerability of the drug will be evaluated throughout the study.

Countries

India

Contacts

Public ContactDr Navneet Kumar Gupta
narsinghverma@gmail.com9839064560

Outcome results

None listed

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