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Efficacy and Safety of Hou Gu Mi Xi in Patients With Spleen Qi Deficiency and Radical Gastrectomy for Gastric Cancer: A Multicenter, Randomized, Double-blinded, Parallel-group, Placebo-controlled Trial (NCT03025152)

The First Affiliated Hospital of Nanchang University
Jiangxi Provincial Cancer Hospital
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 radical gastrectomy for gastric cancer.
  • : Hou Gu Mi Xi
    Hou Gu Mi Xi is a dietary therapy form of Shen Ling Bai Zhu San, which removes atractylodes and platycodon grandiflorum, adds perilla leaf for adapting a dietary therapy.
    • Other: placebo
      The placebo has same appearance, taste and smell as Hou Gu Mi Xi.
      Ages eligible for Study
      18 Years to 70 Years
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      Inclusion Criteria:
      • Patient should be diagnosed as gastric cancer by pathology and have received radical gastrectomy and following radiation and chemotherapy.
      • Patient should be constitution 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 afternoon
      • Main symptoms of qi deficiency: a) fatigue; b) tired mind and taciturnity
      • Secondary symptoms: a) tastelessness, hypodipsia, like hot drink, 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
      • Age ranges from 18 to 70 years; both male and female
      • Patient should be in fair performance status, indicated by a score of Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
      • Sign the informed consent
      Exclusion Criteria:
      • Pregnancy or breast-feeding women
      • Allergic to trial sample or sample composition
      • Impaired liver function, meet one of following conditions: 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
      • Impaired hematopoiesis, meet one of following conditions: a) neutrophil count < 0.5×10^9/L; b) thrombocyte count < 20×10^9/L; or c) absolute reticulocyte count < 15×10^9/L
      • Obviously abnormal electrocardiogram
      • Patients who have severe mental disorders so that could not control his/her action and coordinate the treatment in this trial.
      • Patients who have other severe diseases so that could not participate or finish this trial
      • Patients who are unwilling to provider personal information and enter this trial
      • Patients who cannot understand and sign informed consent
      The incidence of gastric cancer ranks high in many countries around the world. Although along with the development of economy and medical condition the incidence of gastric cancer appears a trend of decrease in developed countries, it is still one of most common cancers in Asia. There are more new gastric cancer cases in China compared with other countries every year. According to an epidemiological survey by World Health Organization, 5-year prevalence of gastric cancer was 53.7/10,000 in China - it is only lower than Japan. For the early gastric cancer, radical gastrectomy, is the most important treatment, which could significantly prolong disease-free survival and overall survival. However, the severe damage of surgery and following radiation and chemotherapy in intestinal tract usually leads patients to be a constitution of spleen qi deficiency, a concept of traditional Chinese medicine (TCM) that mainly involves digestive symptoms, such as poor appetite, abnormal stool (loose, diarrhea) and abdominal distention. Therefore, how to resolve and protect the function of intestinal tract, and change the constitution of spleen qi deficiency postoperatively is important for improving quality of life and reducing the recurrence rate of cancer.

      Shen Ling Bai Zhu San, a classic Chinese medicinal formulae originally described in Tai Ping Hui Min He Ji Ju Fang in the 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 that differs 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. Previous pharmacologic studies also 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.

      According to the experience of TCM, the constitution of patients who are undergoing radiation and chemotherapy is usually yin deficiency, but changes to spleen qi deficiency due to digestive disorders after those treatment. Therefore, Shen Ling Bai Zhu San is expected to improve symptoms in patients who underwent gastrectomy and following radiation and chemotherapy.

      Hou Gu Mi Xi is a dietary therapy form of Shen Ling Bai Zhu San, 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 for a long-term use. Hou Gu Mi Xi uses 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 be different. Therefore, the investigators plan to perform a hospital-based randomized controlled trial, enroll patients from three hospitals in Nanchang City of Jiangxi Province in China, for assessing efficacy and safety of Hou Gu Mi Xi on digestive symptoms in patients with spleen qi deficiency and radical gastrectomy for gastric cancer.

      1 locations

      China (1)
      • Jiangxi University of Traditional Chinese Medicine
        recruiting
        Nanchang, Jiangxi, China, 330004
      Status:
      recruiting
      Type:
      Interventional
      Phase:
      -
      Start:
      30 September, 2016
      Updated:
      18 January, 2017
      Participants:
      130
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