A study testing whether a traditional herbal medicine can improve constipation and gut health in people with irritable bowel syndrome

Adults with constipation-predominant irritable bowel syndrome receiving Zhishi Daozhi Pill compared with placebo for improving bowel movements and symptom severity in a randomized double-blind controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN59688916

Enrollment

120

Registered

2026-03-28

Start date

2025-10-01

Completion date

Unknown

Last updated

2026-04-14

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

Conditions

Treatment of constipation-predominant irritable bowel syndrome in adults Digestive System

Interventions

Participants are randomised in a 1:1 ratio to receive either Zhishi Daozhi Pill or a matched placebo using a computer-generated randomisation schedule with allocation concealment. The intervention gro

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 to 65 years. 2. Diagnosis of constipation-predominant irritable bowel syndrome according to Rome IV criteria. 3. Irritable Bowel Syndrome Severity Scoring System score of 175 or higher at screening. 4. Fewer than 3 complete spontaneous bowel movements per week during the 2-week run-in period. 5. Ability and willingness to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Presence of organic gastrointestinal disease such as inflammatory bowel disease or colorectal cancer. 2. History of gastrointestinal surgery affecting bowel motility. 3. Major psychiatric illness. 4. Pregnancy or breastfeeding. 5. Use of antibiotics, probiotics, prebiotics, or laxatives within 4 weeks prior to enrolment. 6. Participation in another interventional clinical trial. 7. Clinically significant comorbid conditions that could interfere with study participation.

Countries

China

Contacts

Public ContactShaohua Luo

xngbbamm@163.com+8615195272322

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 17, 2026