Efficacy and Safety of Hou Gu Mi Xi in Patients With Spleen Qi Deficiency and Non-organic Gastrointestinal Disorders
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|ClinicalTrials.gov Identifier: NCT03019042|
Recruitment Status : Active, not recruiting
First Posted : January 12, 2017
Last Update Posted : November 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Disease||Dietary Supplement: Hou Gu Mi Xi Other: placebo||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||October 11, 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
Experimental: Hou Gu Mi Xi
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.
Dietary Supplement: Hou 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.
Placebo Comparator: placebo
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.
The placebo has same appearance, taste and smell as Hou Gu Mi Xi.
- 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)
- Change from baseline in Gastrin-17 (ng/L) [ Time Frame: At baseline and 52 and 104 weeks ]To determine whether the interventions improve gastric function
- Quantitative results of gastroscopy [ Time Frame: At baseline and 104 weeks ]To assess pathologic changes
- Changes from baseline in body weight (kg) [ Time Frame: At baseline and 52 and 104 weeks ]To determine whether the interventions improve body weight
- Changes from baseline in body mass index (kg/m2) [ Time Frame: At baseline and 52 and 104 weeks ]To determine whether the interventions improve body mass index
- Incidence of any adverse events [ Time Frame: 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
- Incidence of severe adverse events [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From the first dose of intervention up to 104 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019042
|Jiangxi University of Traditional Chinese Medicine|
|Nanchang, Jiangxi, China, 330004|
|Study Chair:||Weifeng Zhu, Ph.D.||Jiangxi University of Traditional Chinese Medicine|