Treatment of Jianpi Shugan recipe in the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D)

Efficacy of Jianpi Shugan recipe in the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D): a multicentre parallel-group randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN66631530

Enrollment

260

Registered

2015-04-08

Start date

2015-06-01

Completion date

Unknown

Last updated

2015-07-06

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

Conditions

Diarrhoea-predominant irritable bowel syndrome (IBS-D) Digestive System Irritable bowel syndrome with diarrhoea

Interventions

Patients will be randomized to receive either Jianpi Shugan recipe herbal granules + matching Pinaverium placebo or Pinaverium + matching Jianpi Shugan recipe herbal placebo granules for 4 weeks. Herb

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with IBS-D meeting the Rome III criteria 2. Patients meeting the Traditional Chinese Medicine syndrome of liver-depression and spleen-deficiency criteria 3. Patients able to give informed consent 4. Female patients of childbearing potential are willing to use at least one highly effective contraceptive method 5. Aged 18-65 years, either sex

Exclusion criteria

Exclusion criteria: 1. Women who are pregnant or breastfeeding 2. Prior abdominal surgery which may cause bowel symptoms similar to IBS 3. Patients with the following diarrhea conditions: infection, systemic diseases, poisoning or cancer 4. Patients with serious concomitant diseases e.g. cardiovascular, renal, hepatic, respiratory, neurological, endocrine, hematopoietic etc 5. Patients with a history of alcoholic or drug abuse 6. Patients who have allergic constitution or known to be allergic to the drug used in this trial 7. Patients who are involved in other trials 8. Patients with poor compliance or other reasons that the researcher considered not to be appropriate to participate in this trial

Design outcomes

Primary

Measure	Time frame
IBS Symptom Severity Score (IBS-SSS) measured at baseline, 2 weeks and 4 weeks	—

Secondary

Measure	Time frame
1. Traditional Chinese Medicine syndromes of IBS score measured at baseline, 2 weeks and 4 weeks 2. Defection state questionnaire (DSQ) for IBS noted by patients daily 3. Irritable bowel syndrome-quality of life questionnaire (IBS-QOL) at baseline and 4 weeks 4. Serum concentration of serotonin at baseline and 4 weeks	—

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026