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Clinical efficacy evaluation and mechanism exploration of Tongxie Anchang recipe on diarrhea-type irritable bowel syndrome with liver depression and spleen deficiency syndrome by double-blind and double-simulated RCT

Clinical efficacy evaluation and mechanism exploration of Tongxie Anchang recipe on diarrhea-type irritable bowel syndrome with liver depression and spleen deficiency syndrome by double-blind and double-simulated RCT

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075359
Enrollment
Unknown
Registered
2023-09-01
Start date
2019-10-18
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

IBS-D

Interventions

Traditional Chinese Medicine Group:Oral Chinese medicine+Western medicine simulation agent
Western Medicine Group:Oral Western Medicine+Traditional Chinese Medicine Simulator

Sponsors

Dongfang Hospital,Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Patients diagnosed by Western medicine as IBS-D compliant; (2) Those who agree to undergo colonoscopy (those who have reported colonoscopy within the past 3 months may not undergo colonoscopy); (3) Those with IBS-SSS scale scores greater than 75; (4) Traditional Chinese medicine syndrome differentiation belongs to the syndrome of liver stagnation and spleen deficiency; (5) Those aged between 18 and 65; (6) Those who voluntarily participate and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Organic lesions and a history of abdominal surgery (such as cholecystectomy); (2) Patients with severe lesions in major organs such as the liver, brain, and kidneys, as well as patients with mental disorders; (3) Systemic diseases that affect gastrointestinal motility (such as hyperthyroidism, diabetes, chronic renal insufficiency, etc.); (4) Pregnant and lactating women; (5) Those who have used other drugs for the treatment of irritable bowel syndrome within the first week of screening; (6) Allergic constitution, as well as those who are allergic to known ingredients or any excipients of the study drug; (7) Suspected or with a history of alcohol or drug abuse; (8) Those who have participated in other clinical trials within three months;

Design outcomes

Primary

MeasureTime frame
Effective rate calculated based on the degree of abdominal pain and abnormal bowel movements;

Secondary

MeasureTime frame
IBS-SSS scale;TCM syndrome efficiency evaluation;quality of life evaluation;

Countries

China

Contacts

Public ContactXie Chune

Dongfang Hospital Beijing University of Chinese Medicine

xiechune@sina.com+86 136 5101 4735

Outcome results

None listed

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