Peptic Ulcer DiseaseNCT03320538
Efficacy and Safety of Hou Gu Mi Xi in Patients With Peptic Ulcer Diseases
A study testing Hou Gu Mi Xi and Rabeprazole in people with Peptic Ulcer Disease, run by Jiangxi University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peptic Ulcer Disease
- What is being tested?
- Hou Gu Mi Xi and Rabeprazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2017to 17 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangxi University of Traditional Chinese Medicine
Nanchang, Jiangxi, 330004
About this study
Official title: Efficacy and Safety of Hou Gu Mi Xi in Patients With Peptic Ulcer Diseases: A Multicenter, Randomized, Double-blinded, Controlled Trial
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.
Read the 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 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.
- Conditions
- Peptic Ulcer Disease
- Being tested
- Hou Gu Mi Xi, Placebo, Rabeprazole
- Keywords
- Hou Gu Mi Xi, peptic ulcer disease, traditional Chinese medicine, randomized controlled trial, dietary therapy
- Medical subject headings
- Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hou Gu Mi XiOther
Hou Gu Mi Xi is an oatmeal-liked, solid food (dry or dissolved eating).
PlaceboOther
The placebo is as same as Hou Gu Mi Xi in respect of color, taste, and smell.
RabeprazoleDrug
Also called Trade name: Xin Wei An
Rabeprazole is produced by Shanghai Xinyi Pharmaceutical Corp. Ltd.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: At basline and 6, 12, 26, 52 and 104 weeks
Secondary outcomes (12)
Ulcer area (cm^2)
Ulcer area was measured under endoscope.
Measured: At baseline and 12, 26, 52 and 104 weeks
Recurrence rate
For patients who have cured, ulcer is observed again under endoscope during the follow up period is considered as recurrence.
Measured: At baseline and 12, 26, 52 and 104 weeks
Eradication rate of helicobacter pylori
For patients infected with helicobacter pylori, the helicobacter pylori is considered as being eradicated when the result of 13C/14C-urea breath test goes from positive to negative
Measured: At 12, 26, 52 and 104 weeks
Gastrin-17 (pg/ml)
To test the effects of Ho uGu Mi Xi on gastric function
Measured: At baseline and 12, 26, 52 and 104 weeks
Pepsinogen I (ng/ml)
To test the effects of Ho uGu Mi Xi on gastric function
Measured: At baseline and 12, 26, 52 and 104 weeks
Pepsinogen II (ng/ml)
To test the effects of Ho uGu Mi Xi on gastric function
Measured: At baseline and 12, 26, 52 and 104 weeks
Body weight (kg)
To test the regulating effect of Hou Gu Mi Xi on body weight
Measured: At baseline and 12, 26, and 52 weeks
Body mass index (kg/m^2)
To test the regulating effect of Hou Gu Mi Xi on body weight.
Measured: At baseline and 12, 26, and 52 weeks
Adverse events
Incidence of any adverse events. Safety outcome.
Measured: At 6, 12, 26, 52 and 104 weeks
Severe adverse events
Incidence of any severe adverse events. Safety outcome.
Measured: At 6, 12, 26, 52 and 104 weeks
Drug-related adverse events
Incidence of any drug-related adverse events. Safety outcome.
Measured: At 6, 12, 26, and 52 weeks
Withdrawn due to adverse events
Incidence of any drug-related adverse events. Safety outcome.
Measured: At 6, 12, 26, 52 and 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start10 Jul 2017
- Primary completion17 Sep 2020
- Study completion17 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Peptic Ulcer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangxi University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangxi Hospital of Traditional Chinese Medicine, The First Affiliated Hospital of Nanchang University, Second Affiliated Hospital of Nanchang University, The Third Affiliated Hospital of Nanchang University, Nanchang Hongdu Hospital of Traditional Chinese Medicine, Nanchang Hospital of Integrated Traditional Chinese and Western Medicine, Nanchang Third Hospital, Xinyu People's Hospital, Xinyu Hospital of Traditional Chinese Medicine, Jiujiang No.1 People's Hospital, Jiujiang Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Xu Zhou, Jiangxi University of Traditional Chinese Medicine
- Investigators
- Weifeng Zhu, Ph.D., Study chair, Jiangxi University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320538
- Sponsor's protocol ID
- JXUTCM-EBM-03
- Status last verified
- Jul 2024
- First submitted
- 19 Oct 2017
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22310222Li 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.
PubMed 20736940Mohammadi 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.
PubMed 23015509Lanza 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.
PubMed 19240698O'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.
PubMed 25167944Chen 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.
PubMed 31335741
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Hou Gu Mi Xi in Patients With Peptic Ulcer Diseases: A Multicenter, Randomized, Double-blinded, Controlled Trial
- ClinicalTrials.gov ID
- NCT03320538
- Acronym / sponsor ID
- JXUTCM-EBM-03
- Conditions
- Peptic Ulcer Disease
- Keywords
- Hou Gu Mi Xi, peptic ulcer disease, traditional Chinese medicine, randomized controlled trial, dietary therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Jiangxi University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Jiangxi Hospital of Traditional Chinese Medicine, The First Affiliated Hospital of Nanchang University, Second Affiliated Hospital of Nanchang University, The Third Affiliated Hospital of Nanchang University, Nanchang Hongdu Hospital of Traditional Chinese Medicine, Nanchang Hospital of Integrated Traditional Chinese and Western Medicine, Nanchang Third Hospital, Xinyu People's Hospital, Xinyu Hospital of Traditional Chinese Medicine, Jiujiang No.1 People's Hospital, Jiujiang Hospital of Traditional Chinese Medicine
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 17 Sep 2020 (actual)
- Study completion
- 17 Sep 2020 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hou Gu Mi Xi | Experimental | Other: Hou Gu Mi XiBasic 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. |
| Hou Gu Mi Xi + rabeprazole | Experimental | Other: Hou Gu Mi Xi, Drug: RabeprazoleBasic 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. |
| Placebo + rabeprazole | Placebo comparator | Other: Placebo, Drug: RabeprazoleBasic 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. |
| Placebo | Placebo comparator | Other: PlaceboBasic 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Age is between 18 to 70 years
- Sign the informed consent
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hou Gu Mi XiHou Gu Mi Xi is an oatmeal-liked, solid food (dry or dissolved eating). | Other | Hou Gu Mi Xi, Hou Gu Mi Xi + rabeprazole |
| PlaceboThe placebo is as same as Hou Gu Mi Xi in respect of color, taste, and smell. | Other | Placebo, Placebo + rabeprazole |
| RabeprazoleAlso: Trade name: Xin Wei AnRabeprazole is produced by Shanghai Xinyi Pharmaceutical Corp. Ltd. | Drug | Hou Gu Mi Xi + rabeprazole, Placebo + rabeprazole |
Primary outcome
Total effective rate
Time frame: At baseline, and 12, 26, 52, and 104 weeks
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
Quality of ulcer healing
Time frame: At baseline and 12 and 26 weeks
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.
Changes in Spleen Qi Deficiency Symptoms Grading and Quantifying Scale (unit: score on a scale)
Time frame: At basline and 6, 12, 26, 52 and 104 weeks
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.
12 secondary outcomes
Ulcer area (cm^2)
Time frame: At baseline and 12, 26, 52 and 104 weeks
Recurrence rate
Time frame: At baseline and 12, 26, 52 and 104 weeks
Eradication rate of helicobacter pylori
Time frame: At 12, 26, 52 and 104 weeks
Gastrin-17 (pg/ml)
Time frame: At baseline and 12, 26, 52 and 104 weeks
Pepsinogen I (ng/ml)
Time frame: At baseline and 12, 26, 52 and 104 weeks
Pepsinogen II (ng/ml)
Time frame: At baseline and 12, 26, 52 and 104 weeks
Body weight (kg)
Time frame: At baseline and 12, 26, and 52 weeks
Body mass index (kg/m^2)
Time frame: At baseline and 12, 26, and 52 weeks
Adverse events
Time frame: At 6, 12, 26, 52 and 104 weeks
Severe adverse events
Time frame: At 6, 12, 26, 52 and 104 weeks
Drug-related adverse events
Time frame: At 6, 12, 26, and 52 weeks
Withdrawn due to adverse events
Time frame: At 6, 12, 26, 52 and 104 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 22310222Laine 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.
- Background: PubMed 20736940Li 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.
- Background: PubMed 23015509Mohammadi 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.
- Background: PubMed 19240698Lanza 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.
- Background: PubMed 25167944O'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.
- Derived from this study: PubMed 31335741Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weifeng Zhu, Ph.D. study chair
Jiangxi University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hou Gu Mi Xi and Rabeprazole in people with Peptic Ulcer Disease, run by Jiangxi University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total effective rate (time frame: At baseline, and 12, 26, 52, and 104 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03320538, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.