CTRI/2015/10/006252.

Methods	Study design: RCT Settings: India Study period: 15 October 2015 to NR
Participants	Inclusion criteria: active mild‐to‐moderate UC; DAI score 4–10; rectal bleeding score ≥ 1; baseline mucosal appearance score ≥ 1 Exclusion criteria: proximal or universal UC; evidence of signs and symptoms of fulminant colitis, bowel stricture, toxic megacolon, anticipated need for blood transfusion for gastrointestinal bleeding or demonstrated evidence of peritonitis; evidence of dysplasia on biopsy; evidence of enteric pathogens on stool sample Disease activity: NR Disease duration: NR Extent of disease: NR Age: NR Sex (M/F): NR Concurrent therapies: NR Number enrolled: 60 Number randomised: NR Number reaching end of study: NR
Interventions	IG: tacrolimus 2 mg in 60 mL once daily rectally CG: tacrolimus 4 mg in 60 mL once daily rectally
Outcomes	Length of intervention and follow‐up points: 4 weeks Definition of remission or clinical improvement by study authors: NR Number of participants who achieved remission: NR Number of participants who achieved clinical improvement: NR Time to onset of action for tacrolimus from beginning of study: NR Number of participants who required other rescue medication: NR Time to other rescue medication from beginning of study: NR Number of participants who underwent surgery: NR Time to surgery from beginning of study: NR Adverse events: NR Withdrawal due to adverse events: NR Serious adverse events: NR Time to adverse events from beginning of study: NR
Notes	Contacted author by email on 23 November 2020, awaiting response.