CTRI/2018/08/015365.

Study name	Study of efficacy of drug amitriptyline in reducing pain symptoms in children with functional abdominal pain: comparison with placebo
Methods	Randomised, parallel‐group, placebo‐controlled trial
Participants	Children and adolescents aged 7 to 8 years with a functional abdominal pain disorder (FAPD) according to the ROME IV criteria
Interventions	Amitriptyline (10 to 25 mg/day) or placebo for 12 weeks
Outcomes	Primary outcome: effect of amitriptyline on intensity, duration, frequency of pain and daily activity based on the PAIN SCORE TABLE 12 weeks after starting medication. Secondary outcome: effect of amitriptyline on intensity, duration, frequency of pain and daily activity at 1 month after starting medication
Starting date	May 2018 to December 2019
Contact information	Principal Investigator: Ujjal Poddar, Department of Paediatric Gastroenterology, Sanjay Gandhi Postgraduate Institute of Medical Sciences
Notes	ctri.nic.in Identifier: CTRI/2018/08/015365 Principal investigator was contacted, but no response received

CGI: clinical global impression; FOS: Fructo‐oligosacharides