SWORD C Study

JRCT ID: jRCTs021190011

Registered date:13/11/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: irritable bowel syndrome
• Date of first enrollment: 07/07/2020
• Target sample size: 68
• Study type: Interventional

Intervention(s)

A: Yokukansankachimpihange 7.5 g per day for 12 weeks
B: Potato starch 7.5 g per day for 12 weeks

Outcome(s)

• Primary Outcome: Change from baseline in outcome of STAI State Anxiety Inventory score at 12weeks

Secondary Outcome

1. STAI Trait Anxiety Inventory score
2. HADS score
3. IBS-QOL score
4. Daily number of stools
5. Stool consistency
6. Abdominal pain severity, abdominal fullness, anxiety score
7. Improvement rates of abdominal pain severity, abdominal fullness, Anxiety score
8. Insomnia Severity Index

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1. Patients with IBS diagnosed with Rome IV criteria
2. Patients treated at the 1st step in clinical practice guideline of JSGE 2014 at least 4 weeks before randomization.
3. Condition with STAI-state score >= 41
4. Aged 16-75 years at the time of informed consent
5. Provision of written informed consent

Exclude criteria

1. Major abdominal surgery (except appendectomy or hysterectomy)
2. History of inflammatory bowel disease, ischemic colitis, malignant tumor
3. Severe neurological complications (Parkinson's disease, Shy-Drager syndrome, schizophrenia, bipolar disorder)
4. Use of Kampo within 4 weeks prior to randomization
5. Allergy to Kampo
6. Lactose intolerance
7. Allergy to Starch
8. Severe complications (hepatic diseases, serious cardiovascular diseases, hematological diseases, metabolic diseases or malignant neoplasms)
9. Pregnancy, breastfeeding or planning on becoming pregnant throughout the course of the study
10. Unable to take MRI
11. Lack of suitability for participation in the study for any reason as judged by the investigator

Related Information

• Primary Sponsor: Fukudo Shin
• Secondary Sponsor: TSUMURA & CO. Ltd.