FindTrial
Sign In

To confirm the efficacy and safety of Dinggui Oil Capsule in treating irritable bowel syndrome (abdominal pain – the internal cold syndrome): a randomized, double-blind, multi-center, placebo-controlled clinical trial study on the III stage

To confirm the efficacy and safety of Dinggui Oil Capsule in treating irritable bowel syndrome (abdominal pain – the internal cold syndrome): a randomized, double-blind, multi-center, placebo-controlled clinical trial study on the III stage

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13004075
Enrollment
Unknown
Registered
2013-12-24
Start date
2013-12-23
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

irritable bowel syndrome (abdominal pain – the internal cold syndrome)

Interventions

Trial group:Dinggui Oil Capsule
control group:Dinggui Oil Capsule placebo

Sponsors

Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, West China School of Medicine, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Patients fulfill the Western diagnostic criteria of intestinal bowel syndrome; (2) Patients fulfill the internal cold syndrome criteria of traditional Chinese medicine; (3) Aged 18-65 years old; (4) Patient or family member signed the informed consent form; (5) Symptoms within 6 months prior to diagnosis, and persistence in the last three months, the frequency of pain during the observation period are at least two days a week.

Exclusion criteria

Exclusion criteria: (1) patients with complications caused by surgery before the study; (2) patients with alarm symptoms: unexplained weight loss, family history of colon cancer or ovarian cancer, rectal bleeding, fever, anemia, abdominal mass, rectal tumor; (3) patients with intestinal organic disease, hyperthyroidism, diabetes patients; (4) patients with abdominal pain caused by organic disease; (5) Nearly 1 weeks used in treatment of irritable bowel syndrome in patients with other drugs; (6) symptoms 6 months prior to diagnosis, and persistence less than three months, the frequency of pain twice a week; (7) fecal occult blood is positive; (8) patients with chronic liver disease and liver dysfunction; (9) receiving treatment with other drugs; (10) pregnancy or prepare pregnant women, lactating women; (11) allergies or allergic to the drug; (12) patients who is mentally ill.

Design outcomes

Primary

MeasureTime frame
Visual analogue scale method (VAS) changes before versus after of treatment;primary treatment effecacy;—

Countries

China

Contacts

Public ContactChen Guang Yuan

West China Hospital, West China School of Medicine, Sichuan University

gychen0715@gmail.com+86 18980601728

Outcome results

None listed

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