A randomized controlled clinical study of Qinghua Zhixie Recipe in Treating Irritable Bowel Syndrome with Spleen Deficiency and Damp-Heat

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2000003959

Enrollment

Unknown

Registered

2020-09-21

Start date

2020-11-01

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

Irritable Bowel Syndrome

Interventions

1:Qinghua Zhixie Recipe and Pinaverium Bromide Tablets

2:Pinaverium Bromide Tablets

Eligibility

Sex/Gender

All

Age

17 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. According to IBS-D diagnostic criteria of Chinese and Western medicine, 2. gender is not limited, age is 18-70 years old; 3. patients and their families sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Diarrhea caused by Crohn's disease, ulcerative colitis, chemotherapy-induced diarrhea, virus and bacterial infection, diet, lactose intolerance and other causes; 2. Complicated with other digestive tract diseases, such as gastrointestinal tumor, anal disease, intestinal obstruction, perforation, tumor and anal disease; 3. Pregnant, lactation or other cardiovascular and cerebrovascular serious diseases; 4. Taking nonsteroidal drugs within 1 month Anti inflammatory drugs, aspirin or other drugs that may affect visceral sensitivity; 5. Participants in other clinical trials; 6. Patients with allergic history.

Design outcomes

Primary

Measure	Time frame
total effective rate;Total score of TCM Syndromes;	—

Secondary

Measure	Time frame
VIP;TLR4 signaling pathway related gene mRNA;TLR4 signaling pathway related gene mRNA;NPY;NPY;	—

Countries

China

Contacts

Public ContactJi Lijiang

Changshu Traditional Chinese Medicine Hospital

ji512@163.com+86 13962340746

Outcome results

None listed

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