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. 2021 Nov 29;2021(11):CD013531. doi: 10.1002/14651858.CD013531.pub2

JPRN‐UMIN000012635.

Methods Study design: RCT
Setting: Japan
Participants 30 participants aged between 16 and 70 years old
Interventions IG: oral administration of Daikenchuto 15 g/day for 24 weeks in addition to ordinary treatment for Crohn's disease
CG: ordinary treatment for Crohn's disease
Outcomes Date of first enrolment: 25 December 2013
Estimated completion date: NS
Outcomes:
Primary
  1. Abdominal pain (the item 'abdominal pain in the past week' in CDAI)

  2. Abdominal bloating (questions 17 and 20 in Japanese version of IBDQ)


Secondary
  1. CDAI

  2. Japanese version of IBDQ

  3. Serum concentrations and blood mRNA levels of following substances: adrenomedullin, calcitonin gene‐related peptide, receptors for adrenomedullin or calcitonin gene‐related peptide and cytokines

  4. Protein and mRNA levels of following substances in peripheral mononuclear cells: adrenomedullin, calcitonin gene‐related peptide, cytokines and their receptors

  5. Discontinuance rate of study

Notes Funding: Kurume University, Tsumura & Co.
Contact: nina@med.kurume‐u.ac.jp
We received no response from the author and were therefore unable to determine whether this study meets our inclusion criteria.