Efficacy and Safety of Hou Gu Mi Xi in Patients With Peptic Ulcer Diseases

NCT03320538 | Completed DMC

• 1 other identifier: JXUTCM-EBM-03
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Peptic Ulcer Disease

Keywords

Hou Gu Mi Xi; peptic ulcer disease; traditional Chinese medicine; randomized controlled trial; dietary therapy

Outcome Measures

Primary Outcomes (3)

• Total effective rate

  The ulcer was classified for 6 grades: A1: The ulcer is round or elliptical with the center covers thick and white fur; it can be accompanied by errhysis or blood clot, and was surrounded by the obvious flush, hyperemia and edema. A2: The ulcer is covered by yellow or white fur, no bleeding, alleviated congestion and edema H1: The ulcer is healing, no hyperemia and edema disappear around the ulcer; the ulcer moss becomes thin, subside, accompanied by the new capillaries. H2: The ulcer continuously changes to shallow and small. The surrounding mucosa plica centralized to the ulcer. S1: The white fur of ulcer disappears and the new ulcer mucosa presents red. S2: The new ulcer mucosa goes from red to white. Clinical cure: The ulcer heals with or without scar Markedly effective: The healing of ulcer reaches grade H2, or improves 2 grades Effective: The healing of ulcer reaches grade H1, or improves 1 grades Non-effective: No efficacy by the endoscopic observation

  At baseline, and 12, 26, 52, and 104 weeks

• Quality of ulcer healing

  According to Pan et al's method, we will classify the quality of ulcer healing as three ranks by histological assessment: 1) good: integral villus and epithelium, many glands, good morphology, many blood capillary, and few inflammatory cells infiltration. 2) fair: short villus, incomplete or rough epithelium, less glands, structural distortion, few blood capillary, and moderate inflammatory cells infiltration; 3) poor: a little new epithelial cell, poor integrity of epithelium, poor morphology of villus and glands, very few blood capillary, and large amount of inflame cells.

  At baseline and 12 and 26 weeks

• Changes in Spleen Qi Deficiency Symptoms Grading and Quantifying Scale (unit: score on a scale)

  This outcome will be assessed based on the Spleen Qi Deficiency Symptoms Grading and Quantifying Scale (SQD scale) score. Construct of SQD scale: A total of 15 items, of which 7 items assess main symptoms, including stomach pain, stomach distension, acid reflux, abdominal distension, powerless defecation, fatigue and weak, and inappetence; 8 items assess secondary symptoms, including stomach tightness, stomach burn, belching, nausea and vomiting, abnormal stool, tired mind and taciturnity, sallow complexion, and tastelessness and hypodipsia. Scale ranges and explanations: Assessment of each item includes three aspects: degree, frequency in one day, and episodes within one week. The total score of each item is the sum of points of the three aspects. The higher score indicate the worse symptom. The items for assessing main symptoms are double weighted. The score range is 0 to 283 point.

  At basline and 6, 12, 26, 52 and 104 weeks

Secondary Outcomes (12)

• Ulcer area (cm^2)

  At baseline and 12, 26, 52 and 104 weeks

• Recurrence rate

  At baseline and 12, 26, 52 and 104 weeks

• Eradication rate of helicobacter pylori

  At 12, 26, 52 and 104 weeks

• Gastrin-17 (pg/ml)

  At baseline and 12, 26, 52 and 104 weeks

• Pepsinogen I (ng/ml)

  At baseline and 12, 26, 52 and 104 weeks

Study Arms (4)

Hou Gu Mi Xi

EXPERIMENTAL

Basic treatment period (0 to 2rd week): Patients with infection of Helicobacter pylori receive rabeprazole (once 20 mg, twice a day), bismuth potassium citrate (once 0.3 g, twice a day), amoxicillin (once 1 mg, twice a day), and furazolidone (once 0.1 g, twice a day), and patients without infection of Helicobacter pylori only receive rabeprazole (once 20 mg, twice a day) and bismuth potassium citrate (once 0.3 g, twice a day). Maintain treatment period (3rd to 6th week): Patients in this arm receive Hou Gu Mi Xi (once 10 g, twice a day). Recuperation period (7th to 52th week): Patients in this arm receive Hou Gu Mi Xi (once 10 g, twice a day). Extensional observational period (53 to 104 weeks): no intervention.

Other: Hou Gu Mi Xi

Hou Gu Mi Xi + rabeprazole

EXPERIMENTAL

Basic treatment period (0 to 2rd week): Patients with infection of Helicobacter pylori receive rabeprazole (once 20 mg, twice a day), bismuth potassium citrate (once 0.3 g, twice a day), amoxicillin (once 1 mg, twice a day), and furazolidone (once 0.1 g, twice a day), and patients without infection of Helicobacter pylori only receive rabeprazole (once 20 mg, twice a day) and bismuth potassium citrate (once 0.3 g, twice a day). Maintain treatment period (3rd to 6th week): Patients in this arm receive Hou Gu Mi Xi (once 10 g, twice a day) plus rabeprazole (once 10 mg, once a day). Recuperation period (7th to 52th week): Patients in this arm receive Hou Gu Mi Xi (once 10 g, twice a day). Extensional observational period (53 to 104 weeks): no intervention.

Other: Hou Gu Mi Xi; Drug: Rabeprazole

Placebo + rabeprazole

PLACEBO COMPARATOR

Basic treatment period (0 to 2rd week): Patients with infection of Helicobacter pylori receive rabeprazole (once 20 mg, twice a day), bismuth potassium citrate (once 0.3 g, twice a day), amoxicillin (once 1 mg, twice a day), and furazolidone (once 0.1 g, twice a day), and patients without infection of Helicobacter pylori only receive rabeprazole (once 20 mg, twice a day) and bismuth potassium citrate (once 0.3 g, twice a day). Maintain treatment period (3rd to 6th week): Patients in this arm receive Placebo of Hou Gu Mi Xi (once 10 g, twice a day) plus rabeprazole (10 mg/d, qd). Recuperation period (7th to 52th week): Patients in this arm receive Hou Gu Mi Xi (once 10 g, twice a day). Extensional observational period (53 to 104 weeks): no intervention.

Other: Placebo; Drug: Rabeprazole

Placebo

PLACEBO COMPARATOR

Basic treatment period (0 to 2rd week): Patients with infection of Helicobacter pylori receive rabeprazole (once 20 mg, twice a day), bismuth potassium citrate (once 0.3 g, twice a day), amoxicillin (once 1 mg, twice a day), and furazolidone (once 0.1 g, twice a day), and patients without infection of Helicobacter pylori only receive rabeprazole (once 20 mg, twice a day) and bismuth potassium citrate (once 0.3 g, twice a day). Maintain treatment period (3rd to 6th week): Patients in this arm receive placebo of Hou Gu Mi Xi (once 10 g, twice a day). Recuperation period (7th to 52th week): Patients in this arm receive Hou Gu Mi Xi (once 10 g, twice a day). Extensional observational period (53 to 104 weeks): no intervention.

Other: Placebo

Interventions

Hou Gu Mi Xi OTHER

Hou Gu Mi Xi is an oatmeal-liked, solid food (dry or dissolved eating).

Hou Gu Mi Xi; Hou Gu Mi Xi + rabeprazole

Placebo OTHER

The placebo is as same as Hou Gu Mi Xi in respect of color, taste, and smell.

Placebo; Placebo + rabeprazole

Rabeprazole DRUG

Rabeprazole is produced by Shanghai Xinyi Pharmaceutical Corp. Ltd.

Also known as: Trade name: Xin Wei An

Hou Gu Mi Xi + rabeprazole; Placebo + rabeprazole

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangxi University of Traditional Chinese Medicine: lead
• Jiangxi Hospital of Traditional Chinese Medicine: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• The Third Affiliated Hospital of Nanchang University: collaborator
• Nanchang Hongdu Hospital of Traditional Chinese Medicine: collaborator
• Nanchang Hospital of Integrated Traditional Chinese and Western Medicine: collaborator
• The Nanchang Third Hospital: collaborator
• Xinyu People's Hospital: collaborator
• Xinyu Hospital of Traditional Chinese Medicine: collaborator
• Jiujiang No.1 People's Hospital: collaborator
• Jiujiang Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

Jiangxi University of Traditional Chinese Medicine

Nanchang, Jiangxi, 330004, China

Location

Related Publications (6)

• Laine L, Jensen DM. Management of patients with ulcer bleeding. Am J Gastroenterol. 2012 Mar;107(3):345-60; quiz 361. doi: 10.1038/ajg.2011.480. Epub 2012 Feb 7.

  PMID: 22310222 BACKGROUND

• Li Z, Zou D, Ma X, Chen J, Shi X, Gong Y, Man X, Gao L, Zhao Y, Wang R, Yan X, Dent J, Sung JJ, Wernersson B, Johansson S, Liu W, He J. Epidemiology of peptic ulcer disease: endoscopic results of the systematic investigation of gastrointestinal disease in China. Am J Gastroenterol. 2010 Dec;105(12):2570-7. doi: 10.1038/ajg.2010.324. Epub 2010 Aug 24.

  PMID: 20736940 BACKGROUND

• Mohammadi M, Kashani SS, Garoosi YT, Tazehkand SJ. In vivo measurement of Helicobacter pylori infection. Methods Mol Biol. 2012;921:239-56. doi: 10.1007/978-1-62703-005-2_26.

  PMID: 23015509 BACKGROUND

• Lanza FL, Chan FK, Quigley EM; Practice Parameters Committee of the American College of Gastroenterology. Guidelines for prevention of NSAID-related ulcer complications. Am J Gastroenterol. 2009 Mar;104(3):728-38. doi: 10.1038/ajg.2009.115. Epub 2009 Feb 24.

  PMID: 19240698 BACKGROUND

• O'Connor A, Vaira D, Gisbert JP, O'Morain C. Treatment of Helicobacter pylori infection 2014. Helicobacter. 2014 Sep;19 Suppl 1:38-45. doi: 10.1111/hel.12163.

  PMID: 25167944 BACKGROUND

• Chen X, Yan D, Fang J, Liu W, Nie H, Lv N, Fang N, Gong J, Yu J, Jiang Y, Liu Z, Gan H, Fu Y, Yang D, Xiong Y, Liu D, Chen M, Wang Y, Wang Y, Sun X, Zhou X, Zhu W. Efficacy and safety of Hou Gu Mi Xi for peptic ulcer diseases: Study protocol for a randomized controlled trial. Medicine (Baltimore). 2019 Jul;98(29):e16561. doi: 10.1097/MD.0000000000016561.

  PMID: 31335741 DERIVED

MeSH Terms

Conditions

Peptic Ulcer

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Weifeng Zhu, Ph.D.

  Jiangxi University of Traditional Chinese Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 25, 2017
• Study Start: July 10, 2017
• Primary Completion: September 17, 2020
• Study Completion: September 17, 2020
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)