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The effect of Danshu capsule in the treatment dysfunction of Oddi's sphincter after cholecystectomy: a prospective, multicenter clinical trial

The effect of Danshu capsule in the treatment dysfunction of Oddi's sphincter after cholecystectomy: a prospective, multicenter clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029766
Enrollment
Unknown
Registered
2020-02-13
Start date
2019-07-07
Completion date
Unknown
Last updated
2020-02-17

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

Conditions

dysfunction of Oddi's sphincter

Interventions

Case series:Danshu capsule

Sponsors

Shanghai Tongji Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: All of the criteria must be met: 1. Aged 18-70 years old; 2. Patients who have undergone cholecystectomy but still have abdominal pain; 3. Meet the Rome IV diagnostic standard: (1) Meet the diagnostic criteria of biliary pain*; (2) Elevated ALT or ast or AMA, but not simultaneously; (3) There may be dilatation of bile duct or pancreatic duct; (4) No cholelithiasis or other structural abnormality; *Diagnosis standard of biliary pain: the pain is located in the middle and upper abdomen and / or the right upper abdomen, and meets all the following conditions: (1) The pain gradually increased to a stable level, lasting for 30 minutes or longer; (2) The intermittence period was not equal (not daily); (3) The degree of pain may affect the patient's daily activities or force the emergency treatment; (4) The correlation with defecation was not significant (< 20%); (5) There was no significant reduction in pain by changing body position or inhibiting acid treatment (< 20%); 4. Routine blood test, biochemical test (including liver enzyme and pancreatin), abdominal ultrasound and CT after fat meal were performed to eliminate organic diseases; 5. Sign the informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Abdominal pain is caused by organic diseases, such as stone, pancreatitis, pancreatic tumor and liver disease; 2. Diabetes mellitus and thyroid function disease; 3. In patients with severe heart, lung, central nervous system, liver, gallbladder and pancreatic organic diseases, the active phase of liver disease or liver function is abnormal, ALT or AST is more than 2 times the upper limit of normal value; in patients with renal disease or renal insufficiency, SCR is more than 1.3 times the upper limit of normal value; in patients with pancreatitis, amylase and lipase are more than 3 times the upper limit of normal value; Lactation, pregnancy or planned pregnancy women; 4. Those who have participated in or are participating in other clinical trials in the past 3 months; 5. Patients who the researchers think can not be included in the group.

Design outcomes

Primary

MeasureTime frame
pain questionnaire;

Secondary

MeasureTime frame
B-ultrasound;blood;

Countries

China

Contacts

Public ContactChangqing Yang

Shanghai Tongji University

cqyang@tongji.edu.cn+86 13916489072

Outcome results

None listed

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