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Randomized controlled trial of Huoxiang Zhengqi Oral liquid in the treatment of diarrhea-predominant irritable bowel syndrome with dampness pattern and an observational study of diarrhea-predominant irritable bowel syndrome with non-dampness pattern

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026837
Enrollment
Unknown
Registered
2019-10-24
Start date
2019-11-01
Completion date
Unknown
Last updated
2021-09-20

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

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for randomized controlled trials of patients with dampness pattern syndrome 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. Inclusion criteria for observational study of patients with non-dampness syndrome 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 non-dampness; 3. aged 18 to 70 years; 4. basic the ability of reading comprehension; 5. patients have informed consent and signed informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria for randomized controlled trials of patients with dampness syndrome 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. Exclusion criteria for observational study of patients with non-dampness syndrome 1. pregnant and nursing women or women planning pregnancy within 3 months; 2. those who have participated in other clinical trials in the past 3 months; 3. standard points of SAS.>50, standard points of SDS.>53; 4. researchers believe that patients are not suitable for this study.

Design outcomes

Secondary

MeasureTime frame
IBS-QOL;TCM syndrome and signs;EQ-5D-5L;IBS-SSS;

Primary

MeasureTime frame
response rate of adequate relief (AR);

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: ChiCTR (via WHO ICTRP) · Data processed: Feb 22, 2026