Neem for oral lichen planus patients.

Phase 3

Completed

• Conditions: Disorder involving the immune mechanism, unspecified,

• Registration Number: CTRI/2019/01/017246
• Lead Sponsor: Dr Ashita Kalaskar

Brief Summary

Oral lichen planus (OLP) is a chronic mucocutaneous disease with variable etiologies. Literature shows weak evidence of effectiveness of variable treatment options available. Also most of them show complications after chronic use. Hence an alternative and safe approach like herbal therapy should be encouraged. Neem, considered as a wonder drug, exhibits properties which could be benificial for oral lichen planus. Hence this study is planned  to evaluate the efficacy of 10% neem mouthwash in OLP.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-20
• Last Update Posted: 2019-11-23

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 1.Symptomatic Patients with any clinical types and manifestations of OLP and those confirmed histopathologically will be included in the study.
• 2.Patients who have discontinued previous treatment for OLP for last six months.

Exclusion Criteria

• 1.Patients younger than 16 years old.
• 2.Patients with skin lesions.
• 3.Patients with non symptomatic OLP lesions 4.Patients with lesions showing malignant or dysplasic changes.
• 5.Patients undergoing any other treatment for oral lichen planus.
• Pregnant and nursing woman.
• Patients having systemic problems or under any medications for the same.
• Patients having habit of chewing tobacco and betelnut or smoking.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Burning sensation will be evaluated by visual analog scale.	1st day, 3rd day, 7th day, 2nd week, 3rd week, 4th week, 2nd month and 3rd month
evaluated by Thongprasom criteria.	1st day, 3rd day, 7th day, 2nd week, 3rd week, 4th week, 2nd month and 3rd month
The severity of lesions on each side will be	1st day, 3rd day, 7th day, 2nd week, 3rd week, 4th week, 2nd month and 3rd month

Secondary Outcome Measures

Name	Time	Method
Acceptability of neem mouthwash.	Total duration required to decrease the

Trial Locations

Locations (1)

Government dental college and hospital, Nagpur; 🇮🇳 Nagpur, MAHARASHTRA, India

Government dental college and hospital, Nagpur

🇮🇳Nagpur, MAHARASHTRA, India

Ashita Kalskar

Principal investigator

8550928585

kalaskarashita@gmail.com