Efficacy and Safety of Hou Gu Mi Xi in Patients With Spleen Qi Deficiency and Non-organic Gastrointestinal Disorders
Condition: Gastrointestinal Disease
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

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.
    

Intervention name(s): Hou Gu Mi Xi; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 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.; The placebo has same appearance, taste and smell as Hou Gu Mi Xi.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hou Gu Mi Xi; Shen Ling Bai Zhu San; mild gastrointestinal disorders; traditional Chinese medicine; randomized controlled trial