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Development of Formulation Loaded with Polyphenols for the Treatment of Oral Submucous Fibrosis

Design and Development of Mucoadhesive Formulation of Polyphenols for the Treatment of Oral Submucous Fibrosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/037819
Enrollment
6
Registered
2021-11-03
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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: Epigallocatechin 3-gallate: The buccal tissue samples will be collected from patients by using biopsy technique and processed for the generation of primary cell culture. The generated p

Sponsors

Manipal College of Pharmaceutical Sciences MAHE Manipal
Lead Sponsor
Dr Shruthi Acharya
Collaborator
Dr Usha Yogendra Nayak
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Tissues can be included or taken from the patients who confirmed with oral submucous fibrosis (OSMF, disease control) disease and patients without OSMF (normal control). Also, Fibrous bands along the buccal mucosa on clinical examination; histopathological confirmation of punch biopsy.

Exclusion criteria

Exclusion criteria: Patients confirmed with oral cancer.

Design outcomes

Primary

MeasureTime frame
As the OSMF condition increasing day by day, effective treatment strategies are required. In this study, the efficacy of the drug and formulation will be checked on the cells harvested from the biopsy tissue sample which can be used for checking efficacy and cytotoxicity.Timepoint: The tissue will be collected from the patients using biopsy technique and same will be used for the harvesting of cells from collected biopsy tissue sample which requires minimum of 2 to 3 weeks.

Secondary

MeasureTime frame
The generated cells will be used for testing the efficacy of selected polyphenols and prepared formulation of loaded polyphenol by performing the cytotoxicity studies and gene expression study. The cells will be incubated for 72 hrs. for cytotoxicity and gene expression studies. Once the incubation period finished, the cells will used for analyzing the cytotoxicity and expression of genes.Timepoint: The efficacy of the polyphenols and formulation on cells harvested from the biopsy tissue sample and same has been used for the gene expression studies which requires incubation period for almost 72 hrs (3 days).

Countries

India

Contacts

Public ContactDr Shruthi Acharya

Manipal College of Dental Sciences, Manipal

shruthi.acharya@manipal.edu9900409822

Outcome results

None listed

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