A Multicenter, Randomized and Controlled Trial for Chang-An-Jun-Tai Granule in the Treatment of Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D).

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR1900002644

Enrollment

Unknown

Registered

2019-10-04

Start date

2019-10-31

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

Control group:Placebo

Experimental group:Chang-An-Jun-Tai Granule

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: To simultaneously satisfy the following criteria: 1. Conform to the Roman IV(Rome IV) of a patient diagnosed with IBS-D and baseline IBS-SSS score > 75; 2. Aged 18 to 60 years; 3. Nearly 2 weeks no using the drugs in the treatment of IBS; 4. Nearly 2 weeks no using antibiotics or probiotics; 5. The patients volunteered to receive the drug and signed an informed consent form, and the informed consent process was in accordance with the relevant provisions of GCP.

Exclusion criteria

Exclusion criteria: Meet one of the following criteria were excluded: 1. there is explanation above the clinical symptoms of the patients with other diseases; 2. chronic esophagitis, Barrett esophagus and gastroesophageal reflux disease, peptic ulcer, gastric polyp (without resection), digestive tract tumor patients; 3. found that endoscopic gastric mucosa high grade intraepithelial neoplasia, pathological diagnosis, malignant gastrointestinal organic diseases; 4. patients with history of abdominal operation; 5. allergic or allergic to many medicines; 6. confusion, dementia, psychosis, neurosis and various serious unwilling to cooperate; 7. with serious the primary cardiovascular disease, liver disease, kidney disease, blood disease, lung disease, autoimmune diseases, or serious diseases affected the survival, such as cancer or aids; 8. pregnant and lactating women; 9. exist cognitive or other damage (such as vision, etc.) and impact on the participants completed self-report; 10. of the pharmaceutical composition ingredients allergies are; is or 4 weeks in other drug clinical trials of patients; 11. investigators have sufficient reason to believe that the participants according to current medical or psychological state is not suitable for researchers to study.

Design outcomes

Primary

Measure	Time frame
Response rate of IBS-SSS scale;	—

Secondary

Measure	Time frame
Intestinal flora;Metabonomics;IBS-SSS;HAD;IBS-QOL;AR response rate;	—

Countries

China

Contacts

Public ContactFengbin Liu

Guangzhou University of Chinese Medicine

liufb163@163.com+86 13694239909

Outcome results

None listed

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