Clinical trial · Interventional
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
NCT03025152CI-TRIAL-00051447terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): High attrition rate up to 37.7% at one year's follow-up
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastrointestinal Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hou Gu Mi Xi | Dietary Supplement | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hou Gu Mi Xi
- description
- Patients in this arm receive Hou Gu Mi Xi, with an oral dose of 10 g/day during entire follow up period (2 years).
- interventionNames
- Dietary Supplement: Hou Gu Mi Xi
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- Patients in this arm receive placebo, with an oral dose of 10 g/day during entire follow up period (2 years).
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- Changes from baseline in total scores of Spleen Qi Deficiency Symptoms Grading and Quantifying Scale (Units on a scale)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patient should be diagnosed as gastric cancer by pathology and have received radical gastrectomy. They should finish the following radiotherapy and chemotherapy and the treatment for surgical complications (such as leak, stricture, and marginal ulcer). * Patient should be constitution of spleen qi deficiency, that is, meet two primary symptoms of spleen deficiency + two primary symptoms of qi deficiency, or meet two primary symptoms of spleen deficiency + one primary symptoms of qi deficiency + one auxiliary symptoms, or meet one primary symptoms of spleen deficiency + one primary symptoms of qi deficiency + two secondary symptoms + one auxiliary symptoms 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, 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. Auxiliary 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: * Stage IV gastric cancer according to the Japanese classification criteria \[16\] * Impaired liver function (total bilirubin \> 2 × upper limit of normal (ULN), alanine transaminase \> 2 × ULN, or aspartate aminotransferase \> 2 × ULN), kidney function (serum creatinine \> 2 × ULN), or hematopoiesis (neutrophil counts \< 0.5×109/L or, thrombocyte counts \< 20×109/L or, absolute reticulocyte counts \< 15×109/L) * Obviously abnormal electrocardiogram * Severe mental disorders * Other severe diseases (e.g. multiple organ failure, HIV infection) * Pregnant or breast-feeding women * Allergic to the test sample * Unwilling to provider personal information and sign the informed consent
References
Publications (6)
- BACKGROUNDOh SY, Lee HJ, Yang HK. Pylorus-Preserving Gastrectomy for Gastric Cancer. J Gastric Cancer. 2016 Jun;16(2):63-71. doi: 10.5230/jgc.2016.16.2.63. Epub 2016 Jun 24. PMID 27433390
- BACKGROUNDYang L. Incidence and mortality of gastric cancer in China. World J Gastroenterol. 2006 Jan 7;12(1):17-20. doi: 10.3748/wjg.v12.i1.17. PMID 16440411
- BACKGROUNDWu TH, Chen IC, Chen LC. Antacid effects of Chinese herbal prescriptions assessed by a modified artificial stomach model. World J Gastroenterol. 2010 Sep 21;16(35):4455-9. doi: 10.3748/wjg.v16.i35.4455. PMID 20845514
- BACKGROUNDYin GY, Chen Y, Shen XJ, He XF, Zhang WN. Study on the pathophysiologic basis of classification of 'spleen' deficiency in chronic gastritis. Chin Med J (Engl). 2005 Mar 20;118(6):468-73. PMID 15788127
- BACKGROUNDYin GY, Zhang WN, Shen XJ, He XF, Chen Y. Study on the pathological basis of classification of spleen deficiency in chronic gastritis. Chin Med J (Engl). 2004 Aug;117(8):1246-52. PMID 15361303
- DERIVEDZhou X, Yan DM, Zhu WF, Liu WJ, Nie HY, Xu S, Jiang YP, Zhang KH, Fu Y, Wan YY, Yu XY, Li H, Sun X, Chen XF. Efficacy and safety of Hou Gu Mi Xi in patients with spleen qi deficiency syndrome who underwent radical gastrectomy for gastric cancer: protocol for a multicenter, randomized, double-blind, placebo-controlled trial. Trials. 2019 Jun 10;20(1):343. doi: 10.1186/s13063-019-3429-x. PMID 31182140