. 2020 Feb 28;2020(2):CD001168. doi: 10.1002/14651858.CD001168.pub3

015563.

Trial name or title	Benefits of neem for oral lichen planus patients
Methods	Randomised, parallel group, multiple arm trial India
Participants	People with symptoms of OLP attending OPD of Oral Medicine and Radiology Department of S.P.D.C. DMIMS Sawangi, Wardha, India Inclusion criteria: adults with symptoms aged 16–70 years with any clinical types and manifestations of OLP, confirmed histopathologically; people who have discontinued previous treatment for OLP for last 6 months. Exclusion criteria: < 16 years; with skin lesions; with non‐symptomatic OLP lesions; with lesions showing malignant or dysplasic changes; undergoing any other treatment for OLP; pregnant and breastfeeding women; having systemic problems or under any medications for the same; having habit of chewing tobacco and betel nut or smoking.
Interventions	Group A (intervention 1): clobetasol (0.05%) + nystatin (100,000 IU/mL) mouthwash and neem leaves extract mouthwash (5–20%). Participants asked to use mouthwash for 15 minutes, 3 times daily. 1 hour after using clobetasol + nystatin mouthwash, neem leaves extract mouthwash has to be used. Group B (intervention 2): neem leaves mouthwash (5–20%) 3 times daily. Group C: (control): clobetasol (0.05%) + nystatin (100,000 IU/mL) mouthwash 3 times daily.
Outcomes	Primary outcomes: burning sensation (VAS); severity of lesions (Thongprasom) Secondary outcome: acceptability of neem mouthwash; total duration required to decrease the symptoms; recurrence of the lesions
Starting date	17 September 2018
Contact information	Dr Ashita Kalaskar, kalaskarashita@gmail.com
Notes	Sponsor: PI