Efficacy and Safety of Hou Gu Mi Xi in Patients With Peptic Ulcer Diseases
Efficacy and Safety of Hou Gu Mi Xi in Patients With Peptic Ulcer Diseases
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.
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 50% among all PUD patients). One epidemiological survey showed that the
 incidence was 17.2% in China and the ratio of gastric to duodenal ulcer diseases was about
 1:2.

 The two most common reasons for causing PUD were infection of Helicobacter pylori (Hp) and
 long-term use of non-steroid anti-inflammatory drug (NSAID). In recent year, the infection
 rate of Hp increased continuously. Among Chinese PUD patients, 92.6% infected Hp, and 72.2%
 patients who infected Hp occurred PUD. The typical symptoms of PUD were upper abdominal pain,
 abdominal distension, nausea and vomiting, belching, and inappetence. These symptoms were
 cyclical, rhythmic and chronic, and were usually tolerable. However, PUD may progress to
 bleeding or perforation, and these acute complication always lead to worse prognosis.

 Along with the development of medical science, traditional Chinese medicine (TCM) is playing
 an increasingly rule in treatment of PUD. Shen Ling Bai Zhu San is a classic Chinese
 medicinal formulae originally described in Tai Ping Hui Min He Ji Ju Fang in the Fang Song
 Dynasty (1102 AD), which is composed of ginseng, tuckahoe, atractylodes, baked licorice,
 coixenolide, Chinese yam, lotus seed, shrinkage fructus amomi, platycodon grandiflorum, white
 hyacinth bean, and dried orange peel. It is mainly used for treating the syndrome of spleen
 qi deficiency, including dyspepsia, chest and stomach distress, borborygmus and diarrhea,
 limb weakness, thin body, sallow complexion, pale tongue with white and greasy coating, and
 weak and slow pulse, etc.

 In the theory of TCM, spleen is the source for producing qi and blood and thus is the root of
 life. PUD are classed as the syndrome of "Pi Man (fullness)" in TCM, which was caused by
 spleen qi deficiency, imbalance of rise and fall, and/or stagnation of qi activity. Shen Ling
 Bai Zhu San could invigorate spleen by supplying spleen and remove wet, nourish the stomach
 and intestine, and thus improve symptoms of PUD. Pharmacological researches showed that Shen
 Ling Bai Zhu San could regulate function of anaerobic and aerobic bacteria in
 gastrointestinal tract; specifically, it could promote growth of probiotics (e.g.
 bifidobacterium) and inhibit main drug-resistant strains (e.g. enterococcus), and thereby
 enhance the body's self-healing function of ulcer.

 Jiangzhong Hou Gu® Mi Xi™ is a dietary therapy form of Shen Ling Bai Zhu San, of which
 removes atractylodes and platycodon grandiflorum (two herbs that could not be used as food)
 from Shen Ling Bai Zhu San, and adds perilla leaf for adapting a dietary therapy. Jiangzhong
 Hou Gu® Mi Xi™ used the main formula of Shen Ling Bai Zhu San, so that it could theoretically
 maintain the treatment effects. Although the reliable health effects of Shen Ling Bai Zhu San
 has been proved in previous studies, Jiangzhong Hou Gu® Mi Xi™ is optimized in formula and
 its preparations changed from electuary to rice paste, so that its functional mechanism and
 efficacy may also be different. Therefore, the investigators plan to perform a hospital-based
 randomized controlled trial, enroll patients from 13 hospitals in Jiangxi Province in China,
 aims to assess function and safety of Jiangzhong Hou Gu® Mi Xi™ in patients with spleen qi
 deficiency and PUD.
Inclusion Criteria:

 1. 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.

 2. 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

 3. Age is between 18 to 70 years

 4. Sign the informed consent

 Exclusion Criteria:

 1. Patients who have complex peptic ulcer (i.e. have gastric and duodenal ulcer
 meanwhile)

 2. Patients who have history of ulcer complications (e.g. bleeding or perforation)

 3. 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).

 4. 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)

 5. Patients who took proton-pump inhibitor more than 3 days within 15 days, or took
 non-steroid anti-inflammatory drugs for a long term

 6. Female patients who are pregnant or breast-feeding, or prepare to pregnant for
 pregnancy within 2 years

 7. Patients who are allergic to sample or sample composition

 8. Patients who are allergic to sample or sample composition

 9. 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

 10. Patients who have impaired kidney function, that is, serum creatinine >2 ULN

 11. Patients who have obviously abnormal electrocardiogram

 12. 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.

 13. 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

 14. Patients who are receiving any agents or other intervention for treating his/her
 gastrointestinal disorder

 15. Patients with any malignant tumor

 16. Patients who have severe mental disorders so that could not control his/her action and
 coordinate the treatment in this trial.

 17. Patients who are unwilling to provider personal information and enter this trial

 18. Patients who cannot understand and sign informed consent