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Dose-effect relationship of amitriptyline in patients with diarrhea-predominant irritable bowel syndrome and the Influence of CYP2D6 Genotype.

Dose-effect relationship of amitriptyline in patients with diarrhea-predominant irritable bowel syndrome and the Influence of CYP2D6 Genotype.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOD-17011080
Enrollment
Unknown
Registered
2017-04-06
Start date
2017-04-10
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

diarrhea-predominant irritable bowel syndrome

Interventions

TO:placebo for 4 weeks
T1:amitriptyline 25mg/qn, p.o, for 4 weeks
T2:amitriptyline 12.5mg/qn, p.o, for 4 weeks
T3:amitriptyline 6.25mg/qn, p.o, for 4 weeks

Sponsors

Guangzhou First Municipal People's Hospital, Guangzhou Nan Sha Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients from the gastroenterology outpatient of Nansha Center Hospital of Guangzhou First Municipal People's Hospital who conform to the Rome IV criteria for irritable bowel syndrome: Subjects must have had recurrent abdominal pain for 3 or more days per month in the nearly three months for > 6 months and the following 2 symptoms or more: (1) Improvement of symptoms after a bowel movement; (2) Abnormal frequency of defecation; (3) Stool changes. 2. Aged 18-65 years; 3. Signed informed consent and agreed to enter the study.

Exclusion criteria

Exclusion criteria: the presence of any organic disease related to endoscopy; prior gastrointestinal surgery4severe cardiachepatic renal respiratory dysfunction; pregnancy or breast feeding;known allergy to amitriptyline7modertate to severe depression or anxiety

Design outcomes

Primary

MeasureTime frame
IBS-SSS;The Adequate Relief question;Inflammatory factors;Hamilton Depression Rating Scale;Hamilton Anxiety Rating Scale;Pittsburgh Sleep Quality Index;Side effect;CYP2D6 genotypes;serum levels of amitriptyline (At) and nortriptyline (Nt);

Countries

China

Contacts

Public ContactLin Jia

Guangzhou First Municipal People's Hospital, Guangzhou Nan Sha Central Hospital

13925012853@139.com+86 13925012853

Outcome results

None listed

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