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Study on the effect of Shunwei Jiangni granules on the intestinal flora of patients with postprandial discomfort syndrome with cold and heat mismatch based on 16S rDNA high-throughput sequencing technology

Study on the effect of Shunwei Jiangni granules on the intestinal flora of patients with postprandial discomfort syndrome with cold and heat mismatch based on 16S rDNA high-throughput sequencing technology

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000488
Enrollment
Unknown
Registered
2025-03-07
Start date
2025-03-15
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

postprandial discomfort syndrome

Interventions

Chinese medicine treatment group:Treatment with Shunwei Jiangni Granules
Western medicine control group:Treatment with Bifidobacterium tetragonum tablets

Sponsors

Affiliated Hospital of Shanxi University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 99 Years

Inclusion criteria

Inclusion criteria: 1.Patients diagnosed with postprandial discomfort syndrome had no abnormalities on e-gastroscopy;2.Any age included according to actual clinical attendance;3.Chinese medicine diagnosis of cold and heat syndrome;4.Fill out an informed consent form for those interested in participating in a clinical study;5.Have some reading skills.

Exclusion criteria

Exclusion criteria: 1.Those with peptic ulcer erosive gastritis atrophic gastritis or severe heterotrophic hyperplasia found by gastroscopy or pathology or those with pathological diagnosis of suspected malignancy or those who have undergone abdominal surgery;2.Comorbid HP infection gastroesophageal reflux disease irritable bowel syndrome; organic pathology such as chronic pancreatitis cholecystitis or cholelithiasis;3.Those with serious primary heart liver lung and kidney diseases;4.Pregnant and breastfeeding women patients with disabilities as defined by law;5.Suspected or confirmed history of alcohol drug abuse;6.hypersensitive body;7.Patients who are also participating in clinical trials of other drugs or who have recently taken gastrointestinal dynamics drugs proton pump inhibitors etc;8.Persons with serious mental illness;9.non-adherent.

Design outcomes

Primary

MeasureTime frame
Changes in the abundance of intestinal flora;Specific composition of intestinal bacterial microorganisms at the level of phylum, class, order, family, and genus;Structure of gut microorganisms in fecal samples before and after intervention in each sample and each group;Changes in the diversity of intestinal flora;

Secondary

MeasureTime frame
relapse rate;Typical symptoms include stomach and epigastric fullness or pain, aggravated by cold, dry or bitter mouth, dullness, noisy, nausea or vomiting, bowel sounds, and loose stools.;

Countries

China

Contacts

Public ContactPeifang Li

Affiliated Hospital of Shanxi University of Chinese Medicine

fangfang444@163.com15235181143

Outcome results

None listed

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