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

Thomas 2017.

Methods Study design: 3‐arm RCT
Conducted in India
Number of centres: 1
Recruitment period: December 2013 to August 2015
Funding source: unspecified
Participants Inclusion criteria: clinically and histopathologically confirmed OLP without dysplasia in histopathological evaluation and willing to take part in study. Clinical diagnosis was based on the presence of interlacing white striations with intermixed erythematous or ulcerative areas. Histopathological diagnosis based on presence of hydropic degeneration of basal cell layer, dense subepithelial inflammatory infiltrate; participants with symptomatic OLP, i.e. burning sensation, and who had not undergone any previous treatment for the same in the last 6 months.
Exclusion criteria: evidence of lichenoid reaction in clinical or histopathological assessment; having extra oral manifestations of OLP; long‐term glucocorticosteroid therapy for other systemic diseases; with other white lesions such as leukoplakia; systemic lupus erythematosus along with OLP; pregnancy, breastfeeding; history of allergic reactions to corticosteroids or herbal preparations
Group A: randomised 25; analysed 25
Group B: randomised 25; analysed 19
Group C: randomised 25; analysed 25
Interventions Group A: triamcinolone acetonide 0.1% 3 times daily for 2 weeks
Group B: Curenext Oral Gel (Piramel, Health Care, India each gram of which contains curcuma longa extracts 10 mg) 3 times daily for 2 weeks
Group C: Curenext Oral Gel (Piramel, Health Care, India each gram of which contains curcuma longa extracts 10 mg) 6 times daily for 2 weeks
Outcomes Pain (numerical rating scale), clinical score (Modified Oral Mucositis Index)
Notes We compared the outcomes of group A and group C (highest Curenext Oral Gel dose).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement.
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not feasible.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Not feasible.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No missing data in the 2 groups considered for analysis. All randomised participants included in the result analysis.
Selective reporting (reporting bias) Low risk Planned outcomes reported.
Other bias Low risk No other sources of bias identified.