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Phase III Clinical Trial of Kudingxiang Tong Qi Suppository

A randomized, double blinded, placebo controlled, parallel grouped, multi-centre clinical study on safety and efficacy of TQS for restoring gastrointestinal function after abdominal surgery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13004069
Enrollment
Unknown
Registered
2013-04-10
Start date
2012-09-05
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

Post Operative Illes

Interventions

QWE:QQE
QWE:QQE placebo

Sponsors

Renmin Hospital of Beijing University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Open abdominal gastrointestinal surgery; (2) Surgery with general anesthesia, and intravenous analgesia after surgey; (3) Aged 18-75; (4) Volantarily to sign the informed consent file.

Exclusion criteria

Exclusion criteria: (1) Patients under rectal anastomosis or intestinal fistulation; (2) Patients with extensive malignant tumor abdominal cavity metastasis or adhesion; or acute intestinal obstruction; (3) Patients with acidosis/HONKC/severe dehydration/severe electrolyte disorder; (4) Patients complicated with severe cardiac-cerebral vascular disease or severe primary hematopoietic system disease; (5) Patients of Type 1 or 2 diabetic with fasting blood-glucose>8mmol/L; (6) Patients with ALT>1.5 times upper normal limit or Cr> upper normal limit; (7) BMI>30 or BMI2 drugs); (9) Pregnant or lactating women,or who has short term plan for pregnancy; (10) Patients participated in any clinical trials in the past 4 weeks. (11) Patients, decided by the investigator, not suitable for the trial, such as with excessively long operation time, severe complication, unstable respiration and circulation system 12 hours after surgery, ect.

Design outcomes

Primary

MeasureTime frame
Time to first passing flatus: time to first passing flatus after surgery;Time to first passage of stool: time to first passage of stool after surgery;

Secondary

MeasureTime frame
The time to the first bowel sounds by doctor auscultation;Time to first tolerent of solid food;Theoretical discharge time;

Countries

China

Contacts

Public ContactChen Xie

Beijing SNYK Pharmaceutical Ltd

cxie@botaniccentury.com+86 13501261306

Outcome results

None listed

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