Chinese herbal formula Huoxiang Zhengqi for diarrhea-predominant irritable bowel syndrome with dampness pattern (CHAIRS): a double-blinded randomized controlled trial

Postmarket research for two classical formulae of Chinese medicine based on an overarching design

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR1900002709

Enrollment

Unknown

Registered

2019-10-24

Start date

2019-11-01

Completion date

Unknown

Last updated

2023-02-20

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

Conditions

diarrhea-predominant irritable bowel syndrome(IBS-D)

Interventions

Experiment group:Huoxiang Zhengqi Oral Liquid

Control group:Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1 those who meet the diagnostic criteria for IBS-D in Rome IV; 2. those who meet the diagnostic criteria of Chinese medicine pattern of dampness; 3. aged 18 to 70 years; 4. initial IBS-SSS score > 75; 5. basic the ability of reading comprehension; 6. patients have informed consent and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. patients with heart, liver, kidney, hematopoietic system and other serious diseases and tumors, have a history of nervous system and mental illness; 2. patients with warning signs (weight loss within 3 months of emaciation > 10%), hematochezia that is confirmed not to be caused by hemorrhoids or anal fissure , diarrhea at night, fever, family history of colorectal cancer (or polyposis syndrome), inflammatory bowel disease (IBD) or celiac disease. 3. organic diseases of the digestive system, or systemic diseases that affect digestive tract dynamics; 4. patients with a history of abdominal surgery (except caesarean section); 5. those who are unwilling or unable to stop using drugs that affect the effectiveness evaluation of interventions during the study; 6. pregnant and nursing women or women planning pregnancy within 3 months; 7. those who have participated in other clinical trials in the past 3 months; 8. standard points of SAS.>50, standard points of SDS.>53; 9. ALT or AST is 2 times higher than the upper limit of normal range., TBIL or BUN is 1.5 times higher than the upper limit of normal range. 10. patients with a history of drug allergy used in the study; 11. researchers believe that patients are not suitable for this study.

Design outcomes

Primary

Measure	Time frame
IBS-SSS;response rate of adequate relief (AR);	—

Secondary

Measure	Time frame
IBS-QOL;TCM syndrome and signs;EQ-5D-5L;	—

Countries

China

Contacts

Public ContactZehuai Wen

Guangdong Provincial Hospital of Chinese Medicine

wenzh@gzucm.edu.cn+86 020-81887233-35838

Outcome results

None listed

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