Patients in this arm receive Hou Gu Mi Xi, with an oral dose of 10 g/day during entire follow up period (2 years).

Patients in this arm receive placebo, with an oral dose of 10 g/day during entire follow up period (2 years).

Gastric Cancer

Gastrointestinal Disease

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.

Hou Gu Mi Xi

The placebo has same appearance, taste and smell as Hou Gu Mi Xi.

placebo

Jiangxi University of Traditional Chinese Medicine

Efficacy and Safety of Hou Gu Mi Xi in Patients With Spleen Qi Deficiency and Radical Gastrectomy for Gastric Cancer

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

Higher score indicates severer symptoms of Spleen Qi Deficiency. Units of measure (Units on a scale)

1) completely remission: reduction in scores is ≥ 95% compared with baseline; 2) markedly effective: reduction in scores is 70% to 94% compared with baseline; 3) effective: reduction in scores is 30% to 69% compared with baseline; 4) not effective: reduction in scores is < 30% compared with baseline

1) Stomach distension*, 2) Abdominal distension*, 3) Fatigue and weakness*, 4) Tired mind and taciturnity*, 5) Inappetence*, 6) Stomach pain, 7) Stomach tightness, 8) Abdominal pain, 9) Acid reflux, 10) Belching, 11) Nausea and vomiting, 12) Abnormal stools, 13) Abnormal bowel sounds, 14) Powerless defecation, 15) Sallow complexion, 16) Tastelessness and hypodipsia, and 17) Face and limbs edema.

Physical Component Summary (PCS) and Mental Component Summary (MCS)

assessed by evidence of pathological examination, computed tomography and/or magnetic resonance imaging

To determine whether the interventions improve systolic blood pressure

To determine whether the interventions improve diastolic blood pressure

To determine whether the interventions improve body weight

To determine whether the interventions improve body mass index

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]), coagulation function (prothrombin time [PT], activated partial thromboplastin time [APTT], thrombin time [TT], fibrinogen [FIB]), and electrocardiogram as well as any other new-onset symptoms or diseases related or unrelated to the intervention

AEs that lead to new or prolonged hospitalization, disability, admission to intensive care unit, life danger, and death

This outcome is assessed by blinded clinicians in each research center

The investigators do not plan to share individual participant data.

Xu Zhou

Principal Investigator

The First Affiliated Hospital of Nanchang University

Second Affiliated Hospital of Nanchang University

Jiangxi Provincial Cancer Hospital

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.

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.

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.

Efficacy and Safety of Hou Gu Mi Xi in Patients With Spleen Qi Deficiency and Non-organic Gastrointestinal Disorders

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

To determine whether the interventions improve gastric function

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

lablab purpureus/fecundació

Efficacy and Safety of Hou Gu Mi Xi in Patients With Spleen Qi Deficiency and Radical Gastrectomy for Gastric Cancer

Efficacy and Safety of Hou Gu Mi Xi in Patients With Spleen Qi Deficiency and Non-organic Gastrointestinal Disorders

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