Treatment response of spirulina, omega-3 fatty acid and Vitamin E & C in OSMF

Phase 4

Completed

• Conditions: Oral submucous fibrosis,

• Registration Number: CTRI/2020/10/028530
• Lead Sponsor: Maulana Azad Institute of Dental Sciences

Brief Summary

This double blind, randomized parallel group trial will be conducted on patient with Oral Submucous Fibrosis. After inclusion and exclusion criteria, 60 patients are enrolled in the study which will be randomized in 3 equal groups of 20 patients each ( Group A1, A2, and A3). Group A1 will receive Tab Spirullina (500 mg twice daily for 6 months). Group A2 will be given Cap Omega 3 Fatty acid (1 gm twice daily for 6 months) and group A3 will receive Cap Vit. C 500 mg and  Vit. E 400 IU (both twice daily for 6 months). Regular follow will be done at the end of each month upto 6 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-21
• Study Completion: 2021-10-31
• Last Update Posted: 2022-05-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Clinically and histopathologically proven cases of OSMF Restricted mouth opening.

Exclusion Criteria

Patient not willing for participation Patient with severe systemic disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mouth Opening, Tongue Protrusion, Cheek Flexibility, VAS Scale	Pre treatment, 1 month, 3 months and at the end of 6 months

Secondary Outcome Measures

Name	Time	Method
Reporting of any malignant transformation in the span of 6 months	Every 4 weeks till 6 months

Trial Locations

Locations (1)

Maulana Azad Institute of Dental Sciences; 🇮🇳 Central, DELHI, India

Maulana Azad Institute of Dental Sciences

🇮🇳Central, DELHI, India

Dr Ritu Garg

Principal investigator

9650174491

ritu2706@gmail.com