Gastrointestinal DiseaseNCT03019042
Efficacy and Safety of Hou Gu Mi Xi in Patients With Spleen Qi Deficiency and Non-organic Gastrointestinal Disorders
A study testing Hou Gu Mi Xi in people with Gastrointestinal Disease, run by Jiangxi University of Traditional Chinese Medicine at 1 site in China.
Trial summary
This trial aims to determine whether Hou Gu Mi Xi is an effective treatment for improving symptoms and indicators in patients with spleen qi deficiency and mild gastrointestinal disorder. Read more about this study
- Who is it for?
- Ages 14 to 120 years
- Conditions the study is for
- Gastrointestinal Disease
- What is being tested?
- Hou Gu Mi Xi
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2016to 10 Jul 2019
- 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 14 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient should have mild gastrointestinal disorder without any organic pathologic changes (see exclusion criteria) by diagnosis of gastroscopy within 6 months, which mainly include chronic non-atrophic gastritis, functional gastrointestinal disorders, irritable bowel syndrome, and functional dyspepsia
- Patient should be status 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 1 tongue symptom, or have 1 main symptom of spleen deficiency + 1 main symptom of qi deficiency + 2 secondary symptom + 1 tongue symptom as follow:
- Main symptoms of spleen deficiency: a) poor appetite; b) abnormal stool (loose, diarrhea); c) abdominal distention after meal or afternoon
- Main symptoms of qi deficiency: a) fatigue; 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, or remit after meal, or occur when work; c) nausea and vomiting; d) fullness 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
- Fourteen years old or more
- Sign the informed consent
Who cannot join
- Patients who have organic pathologic changes, including peptic ulcer, gastrointestinal erosions, gastroesophageal reflux disease, acute gastrointestinal hemorrhage or perforation, structural changes in gastrointestinal structure, gastrointestinal vascular diseases, ileus, and benign tumor
- Pregnancy or breast-feeding women
- Allergic to sample or sample composition
- impaired liver function, including one of following condition: a) total bilirubin > 2 upper limit of normal (ULN); b) alanine transaminase >2 ULN; or c) aspartate aminotransferase >2 ULN
- impaired kidney function, that is, serum creatinine >2 ULN
- obviously abnormal electrocardiogram
Show all 12Show fewer
- patients who undertaken drugs that could cause damage in stomach and intestine, or patients experience side effects of dyspepsia as 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 Spleen Qi Deficiency and Non-organic Gastrointestinal Disorders: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial
This trial aims to determine whether Hou Gu Mi Xi is an effective treatment for improving symptoms and indicators in patients with spleen qi deficiency and mild gastrointestinal disorder.
Read the detailed description
Chronic gastrointestinal disorders are one of major health problems around the globe. The annual number of patients with chronic gastrointestinal disorders was about 60 to 70 million in American. According to the American statistics in 2014, 4.6 million admissions and 230 thousand patients died due to chronic gastrointestinal disorders. The direct or indirect costs caused by chronic gastrointestinal disorders reached at 142 billion dollars. In China, the incidence of chronic gastrointestinal disorders is 7.3‰ among urban residents, which ranks No. 5 among all diseases and leads to 975 dollars of annually medical costs for per patient.
Along with the development of medical science, traditional Chinese medicine (TCM) is playing an increasingly rule in treatment of chronic gastrointestinal disorders, especially for these mild gastrointestinal disorders which are hard to obtain efficacy in western medicine. Shen Ling Bai Zhu San, a classic Chinese medicinal formulae originally described in Tai Ping Hui Min He Ji Ju Fang in the Fang Song Dynasty (1102 AD), 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 has effects of replenishing qi and invigorating spleen (spleen is a TCM conception different from western medicine), as well as penetrating wet and antidiarrheal. 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. Shen Ling Bai Zhu San could invigorate spleen by supplying spleen and remove wet, and finally nourish the stomach and intestine.
To date, Shen Ling Bai Zhu San is mainly used to treat mild gastrointestinal disorder like irritable bowel syndrome and functional dyspepsia in patients with a TCM syndrome of spleen qi deficiency. Pharmacologic study revealed that Shen Ling Bai Zhu San could adjust function of anaerobic and aerobic bacteria in gastrointestinal tract; specifically, it could improve the proliferation of probiotics (such as bifidobacterium) and inhibit the main resistance strains (such as enterococcus) and thus has an effect to improve gastrointestinal symptoms.
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. 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, 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 five hospitals in Nanchang City of Jiangxi Province in China, for assessing efficacy and safety of Hou Gu Mi Xi on Gastrointestinal symptoms and indicators in Patients with Spleen Qi Deficiency and Mild Gastrointestinal Disorder.
- Conditions
- Gastrointestinal Disease
- Being tested
- Hou Gu Mi Xi, placebo
- Keywords
- Hou Gu Mi Xi, Shen Ling Bai Zhu San, mild gastrointestinal disorders, traditional Chinese medicine, randomized controlled trial
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hou Gu Mi XiDietary supplement
Hou Gu Mi Xi is a dietary therapy form of Shen Ling Bai Zhu San, of which removes atractylodes and platycodon grandiflorum, adds perilla leaf for adapting a dietary therapy.
placeboOther
The placebo has same appearance, taste and smell as Hou Gu Mi Xi.
| Study group | Role | What they receive |
|---|---|---|
| Hou Gu Mi Xi | Experimental | Patients in this arm receive Hou Gu Mi Xi, with oral dose of 30 g/day (contain 10.1 herb materials) during entire follow up period (2 years). HGMX is composed of 10 dietary Chinese herbs (including ginseng (Renshen), tuckahoe (Fuling), coixenolide (Yiyiren), Chinese yam (Shanyao), lotus seed (Lianzi), amomum (Sharen), platycodon (Jiegen), white hyacinth bean (Baibiandou), licorice (Gancao), and orange peel (Jupi)), early rice, and oats. Receives: Dietary Supplement: Hou Gu Mi Xi |
| placebo | Placebo comparator | Patients in this arm receive placebo, with oral dose of 30 g/day during entire follow up period (2 years). The placebo is only consist of early rice and oats. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in total scores of Spleen Qi Deficiency Symptoms Grading and Quantifying Scale (Units on a scale)
Higher score indicates severer symptoms of Spleen Qi Deficiency. Units of measure (Units on a scale)
Measured: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
Secondary outcomes (8)
Change from baseline in Gastrin-17 (ng/L)
To determine whether the interventions improve gastric function
Measured: At baseline and 52 and 104 weeks
Quantitative results of gastroscopy
To assess pathologic changes
Measured: At baseline and 104 weeks
Changes from baseline in body weight (kg)
To determine whether the interventions improve body weight
Measured: At baseline and 52 and 104 weeks
Changes from baseline in body mass index (kg/m2)
To determine whether the interventions improve body mass index
Measured: At baseline and 52 and 104 weeks
Incidence of any adverse events
Assessing by abnormal results (indicated by more or less than 2 × normal reference interval) in the routine blood, urine, and stool tests, liver function tests (alanine transaminase [ALT], aspartate aminotransferase [AST], total bilirubin [TBIL], direct bilirubin [DBIL], indirect bilirubin [IBIL]), kidney function tests (serum creatinine [SCr] and urea nitrogen [BUN]), and electrocardiogram as well as doctor-evaluated and patient-reported adverse events
Measured: From the first dose of intervention up to 104 weeks
Incidence of severe adverse events
AEs that lead to new or prolonged hospitalization, disability, admission to intensive care unit, life danger, and death
Measured: From the first dose of intervention up to 104 weeks
Incidence of drug-related adverse events
This outcome is assessed by blinded clinicians in each research center
Measured: From the first dose of intervention up to 104 weeks
Incidence of withdrawn due to adverse events
Measured: From the first dose of intervention up to 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study start15 Nov 2016
- Primary completion10 Jul 2018
- Study completion10 Jul 2019
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 Gastrointestinal 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangxi University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Nanchang Hongdu Hospital of Traditional Chinese Medicine, Nanchang Hospital of Integrated Traditional Chinese and Western Medicine, The First Affiliated Hospital of Nanchang University, Second Affiliated Hospital of Nanchang University, The Affiliated Hospital of Jiangxi University 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
- NCT03019042
- Sponsor's protocol ID
- JXUTCM-EBM-01
- Status last verified
- May 2020
- First submitted
- 7 Jan 2017
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: The individual participant data are not planned to share.
Publications
Everhart JE, Ruhl CE. Burden of digestive diseases in the United States part I: overall and upper gastrointestinal diseases. Gastroenterology. 2009 Feb;136(2):376-86. doi: 10.1053/j.gastro.2008.12.015. Epub 2009 Jan 3. No abstract available.
PubMed 19124023Farthing M, Roberts SE, Samuel DG, Williams JG, Thorne K, Morrison-Rees S, John A, Akbari A, Williams JC. Survey of digestive health across Europe: Final report. Part 1: The burden of gastrointestinal diseases and the organisation and delivery of gastroenterology services across Europe. United European Gastroenterol J. 2014 Dec;2(6):539-43. doi: 10.1177/2050640614554154. No abstract available.
PubMed 25452850Wu TH, Chen IC, Chen LC. Antacid effects of Chinese herbal prescriptions assessed by a modified artificial stomach model. World J Gastroenterol. 2010 Sep 21;16(35):4455-9. doi: 10.3748/wjg.v16.i35.4455.
PubMed 20845514Yin GY, Chen Y, Shen XJ, He XF, Zhang WN. Study on the pathophysiologic basis of classification of 'spleen' deficiency in chronic gastritis. Chin Med J (Engl). 2005 Mar 20;118(6):468-73.
PubMed 15788127Yin GY, Zhang WN, Shen XJ, He XF, Chen Y. Study on the pathological basis of classification of spleen deficiency in chronic gastritis. Chin Med J (Engl). 2004 Aug;117(8):1246-52.
PubMed 15361303Chen X, Nie H, Liu W, Zhou X, Nie J, Xie B, Chen D, Jiang Y, Zhang K, Fu Y, Yang D, Xiong Y, Zhao Z, Sun X, Zhu W. Efficacy and Safety of Hou Gu Mi Xi on Spleen Qi Deficiency in Patients with Nonorganic Gastrointestinal Disorders: Protocol for a Multicenter, Randomized, Placebo-Controlled Trial. Evid Based Complement Alternat Med. 2018 Dec 2;2018:1980491. doi: 10.1155/2018/1980491. eCollection 2018.
PubMed 30622590
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. 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 Spleen Qi Deficiency and Non-organic Gastrointestinal Disorders: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03019042
- Acronym / sponsor ID
- JXUTCM-EBM-01
- Conditions
- Gastrointestinal Disease
- Keywords
- Hou Gu Mi Xi, Shen Ling Bai Zhu San, mild gastrointestinal disorders, traditional Chinese medicine, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Jiangxi University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Nanchang Hongdu Hospital of Traditional Chinese Medicine, Nanchang Hospital of Integrated Traditional Chinese and Western Medicine, The First Affiliated Hospital of Nanchang University, Second Affiliated Hospital of Nanchang University, The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 12 Jan 2017 (estimated)
- 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 Hou Gu Mi Xi is an effective treatment for improving symptoms and indicators in patients with spleen qi deficiency and mild gastrointestinal disorder.
Detailed description
Chronic gastrointestinal disorders are one of major health problems around the globe. The annual number of patients with chronic gastrointestinal disorders was about 60 to 70 million in American. According to the American statistics in 2014, 4.6 million admissions and 230 thousand patients died due to chronic gastrointestinal disorders. The direct or indirect costs caused by chronic gastrointestinal disorders reached at 142 billion dollars. In China, the incidence of chronic gastrointestinal disorders is 7.3‰ among urban residents, which ranks No. 5 among all diseases and leads to 975 dollars of annually medical costs for per patient.
Along with the development of medical science, traditional Chinese medicine (TCM) is playing an increasingly rule in treatment of chronic gastrointestinal disorders, especially for these mild gastrointestinal disorders which are hard to obtain efficacy in western medicine. Shen Ling Bai Zhu San, a classic Chinese medicinal formulae originally described in Tai Ping Hui Min He Ji Ju Fang in the Fang Song Dynasty (1102 AD), 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 has effects of replenishing qi and invigorating spleen (spleen is a TCM conception different from western medicine), as well as penetrating wet and antidiarrheal. 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. Shen Ling Bai Zhu San could invigorate spleen by supplying spleen and remove wet, and finally nourish the stomach and intestine.
To date, Shen Ling Bai Zhu San is mainly used to treat mild gastrointestinal disorder like irritable bowel syndrome and functional dyspepsia in patients with a TCM syndrome of spleen qi deficiency. Pharmacologic study revealed that Shen Ling Bai Zhu San could adjust function of anaerobic and aerobic bacteria in gastrointestinal tract; specifically, it could improve the proliferation of probiotics (such as bifidobacterium) and inhibit the main resistance strains (such as enterococcus) and thus has an effect to improve gastrointestinal symptoms.
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. 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, 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 five hospitals in Nanchang City of Jiangxi Province in China, for assessing efficacy and safety of Hou Gu Mi Xi on Gastrointestinal symptoms and indicators in Patients with Spleen Qi Deficiency and Mild Gastrointestinal Disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hou Gu Mi Xi | Experimental | Dietary Supplement: Hou Gu Mi XiPatients in this arm receive Hou Gu Mi Xi, with oral dose of 30 g/day (contain 10.1 herb materials) during entire follow up period (2 years). HGMX is composed of 10 dietary Chinese herbs (including ginseng (Renshen), tuckahoe (Fuling), coixenolide (Yiyiren), Chinese yam (Shanyao), lotus seed (Lianzi), amomum (Sharen), platycodon (Jiegen), white hyacinth bean (Baibiandou), licorice (Gancao), and orange peel (Jupi)), early rice, and oats. |
| placebo | Placebo comparator | Other: placeboPatients in this arm receive placebo, with oral dose of 30 g/day during entire follow up period (2 years). The placebo is only consist of early rice and oats. |
Who may qualify
- Ages
- 14 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patient should have mild gastrointestinal disorder without any organic pathologic changes (see exclusion criteria) by diagnosis of gastroscopy within 6 months, which mainly include chronic non-atrophic gastritis, functional gastrointestinal disorders, irritable bowel syndrome, and functional dyspepsia
- Patient should be status 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 1 tongue symptom, or have 1 main symptom of spleen deficiency + 1 main symptom of qi deficiency + 2 secondary symptom + 1 tongue symptom as follow:
- Fourteen years old or more
- Sign the informed consent
Key exclusion criteria (12 listed)
- Patients who have organic pathologic changes, including peptic ulcer, gastrointestinal erosions, gastroesophageal reflux disease, acute gastrointestinal hemorrhage or perforation, structural changes in gastrointestinal structure, gastrointestinal vascular diseases, ileus, and benign tumor
- Pregnancy or breast-feeding women
- Allergic to sample or sample composition
- impaired liver function, including one of following condition: a) total bilirubin > 2 upper limit of normal (ULN); b) alanine transaminase >2 ULN; or c) aspartate aminotransferase >2 ULN
- impaired kidney function, that is, serum creatinine >2 ULN
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 a dietary therapy form of Shen Ling Bai Zhu San, of which removes atractylodes and platycodon grandiflorum, adds perilla leaf for adapting a dietary therapy. | Dietary supplement | Hou Gu Mi Xi |
| placeboThe placebo has same appearance, taste and smell as Hou Gu Mi Xi. | Other | placebo |
Primary outcome
Change from baseline in total scores of Spleen Qi Deficiency Symptoms Grading and Quantifying Scale (Units on a scale)
Time frame: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
Higher score indicates severer symptoms of Spleen Qi Deficiency. Units of measure (Units on a scale)
8 secondary outcomes
Change from baseline in Gastrin-17 (ng/L)
Time frame: At baseline and 52 and 104 weeks
Quantitative results of gastroscopy
Time frame: At baseline and 104 weeks
Changes from baseline in body weight (kg)
Time frame: At baseline and 52 and 104 weeks
Changes from baseline in body mass index (kg/m2)
Time frame: At baseline and 52 and 104 weeks
Incidence of any adverse events
Time frame: From the first dose of intervention up to 104 weeks
Incidence of severe adverse events
Time frame: From the first dose of intervention up to 104 weeks
Incidence of drug-related adverse events
Time frame: From the first dose of intervention up to 104 weeks
Incidence of withdrawn due to adverse events
Time frame: From the first dose of intervention up to 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 11 May 2020.
- Background: PubMed 19124023Everhart JE, Ruhl CE. Burden of digestive diseases in the United States part I: overall and upper gastrointestinal diseases. Gastroenterology. 2009 Feb;136(2):376-86. doi: 10.1053/j.gastro.2008.12.015. Epub 2009 Jan 3. No abstract available.
- Background: PubMed 25452850Farthing M, Roberts SE, Samuel DG, Williams JG, Thorne K, Morrison-Rees S, John A, Akbari A, Williams JC. Survey of digestive health across Europe: Final report. Part 1: The burden of gastrointestinal diseases and the organisation and delivery of gastroenterology services across Europe. United European Gastroenterol J. 2014 Dec;2(6):539-43. doi: 10.1177/2050640614554154. No abstract available.
- Background: PubMed 20845514Wu TH, Chen IC, Chen LC. Antacid effects of Chinese herbal prescriptions assessed by a modified artificial stomach model. World J Gastroenterol. 2010 Sep 21;16(35):4455-9. doi: 10.3748/wjg.v16.i35.4455.
- Background: PubMed 15788127Yin GY, Chen Y, Shen XJ, He XF, Zhang WN. Study on the pathophysiologic basis of classification of 'spleen' deficiency in chronic gastritis. Chin Med J (Engl). 2005 Mar 20;118(6):468-73.
- Background: PubMed 15361303Yin GY, Zhang WN, Shen XJ, He XF, Chen Y. Study on the pathological basis of classification of spleen deficiency in chronic gastritis. Chin Med J (Engl). 2004 Aug;117(8):1246-52.
- Derived from this study: PubMed 30622590Chen X, Nie H, Liu W, Zhou X, Nie J, Xie B, Chen D, Jiang Y, Zhang K, Fu Y, Yang D, Xiong Y, Zhao Z, Sun X, Zhu W. Efficacy and Safety of Hou Gu Mi Xi on Spleen Qi Deficiency in Patients with Nonorganic Gastrointestinal Disorders: Protocol for a Multicenter, Randomized, Placebo-Controlled Trial. Evid Based Complement Alternat Med. 2018 Dec 2;2018:1980491. doi: 10.1155/2018/1980491. eCollection 2018.
- Individual participant dataSharing planned: No. The individual participant data are not planned to share.
Related trials for Gastrointestinal Disease
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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 in people with Gastrointestinal 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 12 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 11 May 2020. 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?
Change from baseline in total scores of Spleen Qi Deficiency Symptoms Grading and Quantifying Scale (Units on a scale) (time frame: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks). 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 NCT03019042, 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 11 May 2020.