A randomized, double-blind, parallel controlled trial for Zhizhu prescription in the treatment of slow transit constipatio

Not Applicable

Recruiting

• Conditions: slow transit constipation

• Registration Number: ITMCTR2000003380
• Lead Sponsor: The Affiliated Hospital of Qingdao University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Patient meets the diagnostic criteria of Rome IV and the diagnosis of deficiency syndrome of traditional Chinese medicine;
(2) Aged 18 to 80 years old (women of childbearing age need to take contraceptive measures during the study period);
(3) The patient can cooperate with the treatment, and the doctor can obtain the patient's detailed history and fill in the score scale of the history;
(4) the interval between the end time of the last other treatment and treatment of this study is more than 1 week;
(5) patients agree not to use any food or drugs that affect gastrointestinal peristalsis during treatment;
(6) patients agree to accept the treatment process and sign an informed consent form.

Exclusion Criteria

(1) women during pregnancy and lactation;
(2) those who are allergic to the drugs in this study;
(3) Patients with outlet obstruction constipation and irritable bowel syndrome;
(4) Those who have taken other defecation promoting drugs within 1 week before treatment or during treatment;
(5) Patients with serious primary diseases such as cardiovascular,urinary, hematopoietic, endocrine system and malignant tumors, and patients with a history of alcohol and drug abuse and psychosis;
(6) Patients with intestinal stenosis caused by organic lesions (such as Crohn's disease, colonic polyps and intestinal tuberculosis) or those with a history of abdominal surgery;
(7) Fail to take medicine according to the regulation, cause curative effect cannot judge, or because the life environment often changes and other factors easily cause the loss of visitors.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bristol stool form scale (BSFS);Therapeutic effect score of TCM syndromes;the Patient Assessment of Constipation Quality of Life (PAC-QOL);Cleveland Clinic Constipation Score (CCS);