Effects of the Renzhuchangle granule on diarrhoea-predominant irritable bowel syndrome

Effects of Renzhuchangle grannule on diarrhoea-predominant irritable bowel syndrome: a randomised, double-blind, placebo-controlled phase IIa study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN42639030

Enrollment

108

Registered

2018-11-30

Start date

2018-12-01

Completion date

Unknown

Last updated

2023-02-13

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 Diarrhoea-predominant irritable bowel syndrome (IBS-D)

Interventions

Participants are randomly allocated to one of three groups using SAS9.10 software: 1. Renzhuchangle granule 8 g, taken orally three times per day for 8 weeks 2. Renzhuc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diarrhoea-predominant irritable bowel syndrome (IBS-D) meeting the Rome IV criteria 2. Meeting the Traditional Chinese Medicine syndrome of liver-depression and spleen-deficiency criteria 3. Aged 18 to 65 4. Voluntary acceptance of the medication 5. Signed informed consent 6. Average daily worst abdominal pain score =3 during the last week of screening phase 7. More than two days of =1 loose stools (Bristol Stool Scale 6 or 7) during the last week of screening phase

Exclusion criteria

Exclusion criteria: 1. Prior abdominal surgery which may cause bowel symptoms similar to IBS 2. Diarrhoea as a result of any of the following: 2.1. Infection 2.2. Systemic diseases 2.3. Poisoning 2.4. Cancer 3. Serious concomitant diseases, including cardiovascular, renal, hepatic, respiratory, neurological, endocrine or haematopoietic diseases 4. History of alcohol or drug abuse 5. Allergic constitution or known to be allergic to the drug used in this trial 6. Involved in other trials 7. Pregnant or breastfeeding, or plan to become pregnant soon 8. Poor compliance or any other reason the research believers they may not be appropriate to participate in this trial

Design outcomes

Primary

Measure	Time frame
The following will be assessed by reviewing patient notes at the baseline and weekly from weeks 1-8: 1. Abdominal pain score 2. Stool consistency	—

Secondary

Measure	Time frame
1. Abdominal bloating, assessed by reviewing patient notes at the baseline and after 2, 4 and 8 weeks 2. IBS symptom servirty, assessed using the Irritable Bowel Syndrome Symptom Severity Scoring System (IBS-SSS) at the baseline and after 8 weeks 3. Traditional Chinese Medicine syndromes of IBS score, assessed at the baseline and after 8 weeks 4. Quality of life, assessed using the Irritable Bowel Syndrome Quality of Life questionnaire (IBS-QOL) at the baseline and after 8 weeks	—

Measure

Time frame

1. Abdominal bloating, assessed by reviewing patient notes at the baseline and after 2, 4 and 8 weeks 2. IBS symptom servirty, assessed using the Irritable Bowel Syndrome Symptom Severity Scoring System (IBS-SSS) at the baseline and after 8 weeks 3. Traditional Chinese Medicine syndromes of IBS score, assessed at the baseline and after 8 weeks 4. Quality of life, assessed using the Irritable Bowel Syndrome Quality of Life questionnaire (IBS-QOL) at the baseline and after 8 weeks

—

Countries

China

Contacts

Public ContactShengsheng Zhang

Outcome results

None listed

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