Gastrointestinal Disease
Conditions
Keywords
Hou Gu Mi Xi, Shen Ling Bai Zhu San, mild gastrointestinal disorders, traditional Chinese medicine, randomized controlled trial
Brief 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.
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.
Interventions
DIETARY_SUPPLEMENTHou Gu Mi Xi
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.
OTHERplacebo
The placebo has same appearance, taste and smell as Hou Gu Mi Xi.
Sponsors
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
Jiangxi University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
* 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: 1. Main symptoms of spleen deficiency: a) poor appetite; b) abnormal stool (loose, diarrhea); c) abdominal distention after meal or afternoon 2. Main symptoms of qi deficiency: a) fatigue; b) tired mind and taciturnity 3. 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 4. Tongue symptoms: pale or swollen or teeth-printed tongue with thin and white fur * Fourteen years old or more * Sign the informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in total scores of Spleen Qi Deficiency Symptoms Grading and Quantifying Scale (Units on a scale) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative results of gastroscopy | At baseline and 104 weeks | To assess pathologic changes |
| Changes from baseline in body weight (kg) | At baseline and 52 and 104 weeks | To determine whether the interventions improve body weight |
| Changes from baseline in body mass index (kg/m2) | At baseline and 52 and 104 weeks | To determine whether the interventions improve body mass index |
| Change from baseline in Gastrin-17 (ng/L) | At baseline and 52 and 104 weeks | To determine whether the interventions improve gastric function |
| Incidence of severe adverse events | From the first dose of intervention up to 104 weeks | AEs that lead to new or prolonged hospitalization, disability, admission to intensive care unit, life danger, and death |
| Incidence of drug-related adverse events | From the first dose of intervention up to 104 weeks | This outcome is assessed by blinded clinicians in each research center |
| Incidence of withdrawn due to adverse events | From the first dose of intervention up to 104 weeks | — |
| Incidence of any adverse events | From the first dose of intervention up to 104 weeks | 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 |
Countries
China
Outcome results
None listed