Status:
COMPLETED
Efficacy and Safety of Hou Gu Mi Xi in Patients With Peptic Ulcer Diseases
Lead Sponsor:
Jiangxi University of Traditional Chinese Medicine
Collaborating Sponsors:
Jiangxi Hospital of Traditional Chinese Medicine
The First Affiliated Hospital of Nanchang University
Conditions:
Peptic Ulcer Disease
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This trial aims to determine whether Jiangzhong Hou Gu® Mi Xi™ is an effective intervention to improve symptoms and indicators in patients with spleen qi deficiency and peptic ulcer diseases.
Detailed Description
Peptic ulcer diseases (PUD) is a common kind of digestive system disease, which mostly involves in stomach and duodenum. PUD may occur at any age but mainly at 30 to 49 years (the proportion was about...
Eligibility Criteria
Inclusion
- Patient should be diagnosed as gastric or duodenal ulcer under endoscope; the diameter of ulcers range from 0.3 to 1.0 cm; no indicator of bleeding or perforation.
- Patient should be diagnosed as syndrome of spleen qi deficiency, that is, meet 2 main symptoms of spleen deficiency and 2 main symptoms of qi deficiency, or have 2 main symptoms of spleen deficiency, 1 main symptoms of qi deficiency and tongue symptoms as follow:
- Main symptoms of spleen deficiency: a) poor appetite; b) abnormal stool (loose, diarrhea); c) abdominal distention after meal or at afternoon
- Main symptoms of qi deficiency: a) fatigue and weak; b) tired mind and taciturnity
- Secondary symptoms: a) tastelessness, hypodipsia, like hot drink, or polysialia; b) abdominal pain, as a result either patients like warm or press; pain remits after meal or occurs when work; c) nausea and vomiting; d) tightness in stomach; e) abnormal bowel sounds; f) lean or puffiness; g) sallow complexion; h) powerless defecation weakness; i) edema
- Tongue symptoms: pale or swollen or teeth-printed tongue with thin and white fur
- Age is between 18 to 70 years
- Sign the informed consent
Exclusion
- Patients who have complex peptic ulcer (i.e. have gastric and duodenal ulcer meanwhile)
- Patients who have history of ulcer complications (e.g. bleeding or perforation)
- Patients who have indicators of ulcer complications, including bleeding (Forrest stage I, IIa and IIb) or perforation (area of ulcer is more than 1 cm).
- Patients whose ulcer have healed, that is, the ulcer is at healing stage or scarring stage according to the diagnosis criteria in Consensus View of Integrated Chinese and Western Medicine on Diagnosis and Treatment of Peptic Ulcer (2011, Tianjin)
- Patients who took proton-pump inhibitor more than 3 days within 15 days, or took non-steroid anti-inflammatory drugs for a long term
- Female patients who are pregnant or breast-feeding, or prepare to pregnant for pregnancy within 2 years
- Patients who are allergic to sample or sample composition
- Patients who are allergic to sample or sample composition
- Patients who have impaired liver function, including one of following condition: a) total bilirubin \> 35 μmol/L; b) alanine transaminase \>2 upper limit of normal (ULN); or c) aspartate aminotransferase \>2 ULN
- Patients who have impaired kidney function, that is, serum creatinine \>2 ULN
- Patients who have obviously abnormal electrocardiogram
- Patients who have stool occult blood, that is, positive result in immunoassay or iron elemental test, and the results continue to be positive after 3 days of vegetarian diet.
- Patients who undertaken drugs that could damage stomach and intestine, or experienced side effects of dyspepsia for undertaking non-steroidal anti-inflammatory drugs, theophylline, oral antibiotic or potassium supplements within 3 months
- Patients who are receiving any agents or other intervention for treating his/her gastrointestinal disorder
- Patients with any malignant tumor
- Patients who have severe mental disorders so that could not control his/her action and coordinate the treatment in this trial.
- Patients who are unwilling to provider personal information and enter this trial
- Patients who cannot understand and sign informed consent
Key Trial Info
Start Date :
July 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2020
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT03320538
Start Date
July 10 2017
End Date
September 17 2020
Last Update
July 3 2024
Active Locations (1)
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1
Jiangxi University of Traditional Chinese Medicine
Nanchang, Jiangxi, China, 330004