A randomized, double-blind, placebo-controlled clinical study of Chaihu Shugan Powder in the treatment of functional dyspepsia

Not Applicable

Recruiting

• Conditions: Functional Dyspepsia

• Registration Number: ITMCTR2100004782
• Lead Sponsor: Zhoupu Hospital, Pudong New Area, Shanghai

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.Meet the Western medical diagnostic criteria of Rome IV functional dyspepsia;
2.Meet the TCM diagnostic criteria for functional dyspepsia and liver-stomach discord;
3.Aged 18~65 years, no gender limit, outpatient;
4.Gastroscopy, B-ultrasound, CT examination, etc. have been performed within 6 months before selection to exclude related organic, systemic and metabolic diseases;
5.Carbon 13 or Carbon 14 breath test or endoscopic pathological test for Helicobacter pylori negative within 6 months before enrollment, or negative after treatment, 13C or 14C breath test should be performed within 6 months before enrollment;
6.The subjects gave informed consent and signed the informed consent form.

Exclusion Criteria

1.The syndrome differentiation is not clear or there are too many mixed syndromes;
2.Drugs that interfere with this study have been taken within 2 weeks before treatment, such as gastrointestinal-related drugs such as promoting gastrointestinal motility and anti-gastric acid secretion;
3.Those who are allergic or allergic to multiple drugs, and those who are allergic to Chaihu Shugan Powder and its components;
4.Those with a history of abdominal surgery;
5.Patients with overlapping syndromes of gastroesophageal reflux and irritable bowel syndrome;
6.Patients with connective tissue diseases, diabetes and other endocrine and metabolic diseases, and menopausal syndrome; those with severe primary heart, liver, lung, kidney, blood or serious diseases that affect their survival;
7.Suspected or clear history of drug or alcohol abuse;
8.Acupuncture, massage, cupping, ear points and other non-drug treatments;
9.Patients with severe psychological disorder, mental illness or severe neurosis; patients with cognitive language impairment;
10.Patients during pregnancy, lactation or planning to become pregnant;
11.Disabled patients (blind, deaf, mute, mentally handicapped, physical disability) prescribed by law;
12.According to the judgment of the investigator, there are other situations that reduce the possibility of enrollment or complicate enrollment, such as frequent business trips, frequent changes in work environment and residence, which may cause loss to follow-up;
13.Those who have received other drug clinical trials within the past 3 months;
14.Those considered by the researcher to be unsuitable for enrollment.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Traditionl Chinese Medicine Syndrome Points;Barium strip gastric emptying rate detection;Anxiety, Depression Score;Symptom score;