Multicenter, placebo-controlled, double-blind, randomized controlled trial of daikenchuto for patients with functional constipation

Multicenter, placebo-controlled, double-blind, randomized controlled trial of daikenchuto for patients with functional constipation - the effects of daikenchuto in patients with functional constipation.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000020570

Enrollment

Registered

2016-01-14

Start date

2016-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic constipation defined by Rome III criteria (functional constipation or constipation predominant irritable bowel syndrome)

Interventions

daikenchuto 5 g tid ingested immediately before meals for 28 consecutive days placebo 5 g tid ingested immediately before meals for 28 consecutive days

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: functional constipation without evidence of evacuation disorder

Exclusion criteria

Exclusion criteria: Patients with structural or metabolic conditions that affect the gastrointestinal system or with functional gastrointestinal disorders other than constipation; history of allergic reactions to egg, ginseng, ginger and Sichuan pepper or lactose intolerance; history of uncontrolled medical con- ditions (e.g. significant cardiovascular, respiratory, renal, hepatic, haematological, neurological or psychiatric diseases); or current use of any medication that could potentially alter GI transit.

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of daikenchuto for 4 weeks on symptoms, colonic transit time and gas volume in Japanese patients with chronic constipation	—

Countries

Japan

Contacts

Public ContactNoriaki Manabe

Kawasaki Medical School Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine

n_manabe@hkg.odn.ne.jp086-462-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026