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A randomized, double-blind, placebo-controlled, multicenter clinical trial for Chenxiang Qu in the treatment of functional dyspepsia with postprandial discomfort syndrome(Liver-stomach Disharmony Syndrome)

A randomized, double-blind, placebo-controlled, multicenter clinical trial for Chenxiang Qu in the treatment of functional dyspepsia with postprandial discomfort syndrome(Liver-stomach Disharmony Syndrome)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024909
Enrollment
Unknown
Registered
2019-08-03
Start date
2019-07-22
Completion date
Unknown
Last updated
2019-08-27

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

Conditions

functional dyspepsia with postprandial discomfort syndrome(Liver-stomach Disharmony Syndrome)

Interventions

Experimental group:Chenxiang Qu, 9g, take orally, bid
Control group:Placebo, 9g, take orally, bid

Sponsors

Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria of functional dyspepsia postprandial discomfort syndrome; (2) Meet the diagnostic criteria of Liver-stomach Disharmony Syndrome; (3) Between 18 to 65 years old; (4) Voluntary participation and signing of informed consent

Exclusion criteria

Exclusion criteria: (1) Dyspepsia caused by organic diseases of digestive system, such as peptic ulcer, gastroesophageal reflux disease, erosive gastritis (grade 2 or more), atrophic gastritis, gastrointestinal cancer, gastrointestinal bleeding, hepatobiliary and pancreatic diseases, intestinal obstruction, inflammatory bowel disease, etc. B-mode ultrasonography, gastroscopy and laboratory examination showed abnormalities. There were significant evidence of gastrointestinal bleeding, gastrointestinal inflammation (ulcer, erosion, bleeding), including black stool, hematemesis, and palpable abdominal mass; (2) Hp positive; (3) Progressive dysphagia and swallowing pain, persistent vomiting and unconscious weight loss; (4) systemic diseases affecting digestive tract motility, such as diabetes mellitus, chronic renal insufficiency, connective tissue disease, neuropathy, etc.; (5) Abdominal surgery (except appendectomy and cesarean section); (6) Immune deficiency (such as leukemia, cancer patients, etc.) or the use of immunosuppressive agents or glucocorticoids in the past three months; (7) Severe cardiac insufficiency, liver and kidney function (ALT/AST is 1.5 times higher than the upper limit of normal value), endocrine system and hematopoietic system abnormalities, hematological examination indicates iron deficiency anemia; (8) Those with serious primary heart, brain, liver, lung, kidney, blood or serious diseases affecting their survival; (9) Disabled patients prescribed by law (blind, deaf, dumb, mental retardation, mental retardation, physical disability); (10) Pregnancy (positive pregnancy test for women of childbearing age) or lactation women, patients with recent fertility plans; (11) Allergic constitution, such as those who have allergic history to two or more medicines or food, and those who are allergic to the composition of this preparation; (12) Recent or ongoing clinical trials of other drugs, or drugs taken, may have an impact on the evaluation of the effectiveness of the tested drugs; (13) suspected or confirmed history of alcohol and drug abuse; (14) Severe anxiety and depression.

Design outcomes

Primary

MeasureTime frame
Upper abdominal distension, early satiety and belching severity score;

Secondary

MeasureTime frame
TCM Syndrome Scoring;Evaluation of Western Medicine Symptoms;SF-36;Usage of Mosapride;

Countries

China

Contacts

Public ContactJunxiang Li

Dongfang Hospital Affiliated to Beijing University of Chinese Medicine

616606426@qq.com+86 010 67689751

Outcome results

None listed

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