Skip to content

Study on Therapeutic Effect and Mechanism of Jianpi Liqi Granules on Functional Dyspepsia with Spleen Deficiency Syndrome: a Randomized Controlled Double-Blind Trial

Study on Therapeutic Effect and Mechanism of Jianpi Liqi Granules on Functional Dyspepsia with Spleen Deficiency Syndromea: a Randomized Controlled Double-Blind Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052319
Enrollment
Unknown
Registered
2021-10-24
Start date
2019-09-30
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Functional dyspepsia

Interventions

experimental group:Jianpi Liqi granule
control group:placebo

Sponsors

Guangdong Province Traditional Chinese Medical Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the Rome IV diagnostic criteria of functional dyspepsia in western medicine and the TCM syndrome criteria of spleen deficiency and qi stagnation syndrome in traditional Chinese medicine; 2. The main symptom score of the enrolled patients should be above grade II. 3. The age is between 18 and 65 years old, regardless of gender; 4. The subject shall sign the informed consent on the basis of knowing the purpose, risk and benefit of the test. 5. HP negative.

Exclusion criteria

Exclusion criteria: 1. Dyspepsia caused by organic diseases of digestive system, such as peptic ulcer, reflux esophagitis, erosive gastritis (above grade 2), atrophic gastritis, gastrointestinal tumor, gastrointestinal bleeding, hepatobiliary and pancreatic diseases, intestinal obstruction, inflammatory bowel disease, etc; 2. there are systemic diseases affecting gastrointestinal motility, such as diabetes, chronic renal insufficiency, connective tissue disease and nervous system diseases. 3. Those with serious primary heart, brain, liver, lung, kidney, blood or serious diseases affecting their survival; 4. History of abdominal surgery (except appendectomy and cesarean section); 5. Pregnant and lactating women, patients with recent family planning; 6. Patients with disabilities specified by law (blind, deaf, mute, intellectual disorder, mental disorder, physical disability); 7. Suspected or true history of alcohol and drug abuse.

Design outcomes

Primary

MeasureTime frame
Histological morphology;Intestinal mucosal permeability;Microinflammation of the intestinal mucosa;

Countries

China

Contacts

Public ContactSuiping Huang

Guangdong Province Traditional Chinese Medical Hospital

gzdoctorhsp@126.com+86 13711026653

Outcome results

None listed

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