Gastric CancerNCT03025152
Efficacy and Safety of Hou Gu Mi Xi in Patients With Spleen Qi Deficiency and Radical Gastrectomy for Gastric Cancer
A study testing Hou Gu Mi Xi in people with Gastric Cancer and Gastrointestinal Disease, run by Jiangxi University of Traditional Chinese Medicine at 1 site in China.
Trial 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 radical gastrectomy for gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer, Gastrointestinal Disease
- What is being tested?
- Hou Gu Mi Xi
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2016to 20 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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
- Auxiliary symptoms: pale or swollen or teeth-printed tongue with thin and white fur
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangxi University of Traditional Chinese Medicine
Nanchang, Jiangxi, 330004
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Gastric Cancer, Gastrointestinal Disease
- Being tested
- Hou Gu Mi Xi, placebo
- Keywords
- Hou Gu Mi Xi, Shen Ling Bai Zhu San, radical gastrectomy, gastric cancer, traditional Chinese medicine, randomized controlled trial
- Medical subject headings
- Stomach Neoplasms, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hou Gu Mi XiDietary supplement
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.
placeboOther
The placebo has same appearance, taste and smell as Hou Gu Mi Xi.
| Study group | Role | What they receive |
|---|---|---|
| Hou Gu Mi Xi | Experimental | Patients in this arm receive Hou Gu Mi Xi, with an oral dose of 10 g/day during entire follow up period (2 years). Receives: Dietary Supplement: Hou Gu Mi Xi |
| placebo | Placebo comparator | Patients in this arm receive placebo, with an oral dose of 10 g/day during entire follow up period (2 years). Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in total scores of Spleen Qi Deficiency Symptoms Grading and Quantifying Scale (Units on a scale)
Higher score indicates severer symptoms of Spleen Qi Deficiency. Units of measure (Units on a scale)
Measured: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
Secondary outcomes (14)
Qualitative assessment of changes in total scores of SQD scale from baseline
- 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
Measured: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
Changes in scores of each item of SQD scale from baseline
- 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.
Measured: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
Changes from baseline in total scores of Short Form 36 (SF-36) (Units on a scale)
To assess quality of life
Measured: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
Changes from baseline in scores of subitems in Short Form 36 (SF-36) (Units on a scale)
Physical Component Summary (PCS) and Mental Component Summary (MCS)
Measured: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
Changes from baseline in scores of Eastern Cooperative Oncology Group (ECOG) Performance Status (Units on a scale)
To assess performance status
Measured: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
Progression free survival (month)
assessed by evidence of pathological examination, computed tomography and/or magnetic resonance imaging
Measured: From the first dose of intervention up to 104 weeks
Changes from baseline in systolic blood pressure (mmHg)
To determine whether the interventions improve systolic blood pressure
Measured: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
Changes from baseline in diastolic blood pressure (mmHg)
To determine whether the interventions improve diastolic blood pressure
Measured: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
Changes from baseline in body weight (kg)
To determine whether the interventions improve body weight
Measured: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
Changes from baseline in body mass index (kg/m2)
To determine whether the interventions improve body mass index
Measured: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
Incidence of any adverse events
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
Measured: From the first dose of intervention up to 104 weeks
Incidence of severe adverse events
AEs that lead to new or prolonged hospitalization, disability, admission to intensive care unit, life danger, and death
Measured: From the first dose of intervention up to 104 weeks
Incidence of drug-related adverse events
This outcome is assessed by blinded clinicians in each research center
Measured: From the first dose of intervention up to 104 weeks
Incidence of withdrawn due to adverse events
Measured: From the first dose of intervention up to 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study start11 Nov 2016
- Primary completion20 Jul 2019
- Study completion20 Jul 2019
Why it stopped: High attrition rate up to 37.7% at one year's follow-up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangxi University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Nanchang University, Second Affiliated Hospital of Nanchang University, Jiangxi Provincial Cancer Hospital
- Responsible party
- Principal investigator, Xu Zhou, Jiangxi University of Traditional Chinese Medicine
- Investigators
- Weifeng Zhu, Ph.D., Study chair, Jiangxi University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025152
- Sponsor's protocol ID
- JXUTCM-EBM-02
- Status last verified
- Apr 2021
- First submitted
- 17 Jan 2017
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to share individual participant data.
Publications
Oh 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.
PubMed 27433390Yang 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.
PubMed 16440411Wu 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.
PubMed 20845514Yin 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.
PubMed 15788127Yin 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.
PubMed 15361303Zhou 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.
PubMed 31182140
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03025152
- Acronym / sponsor ID
- JXUTCM-EBM-02
- Conditions
- Gastric Cancer, Gastrointestinal Disease
- Keywords
- Hou Gu Mi Xi, Shen Ling Bai Zhu San, radical gastrectomy, gastric cancer, traditional Chinese medicine, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: High attrition rate up to 37.7% at one year's follow-up
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Jiangxi University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Nanchang University, Second Affiliated Hospital of Nanchang University, Jiangxi Provincial Cancer Hospital
- Study start
- 11 Nov 2016 (actual)
- Primary completion
- 20 Jul 2019 (actual)
- Study completion
- 20 Jul 2019 (actual)
- First posted
- 19 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hou Gu Mi Xi | Experimental | Dietary Supplement: Hou Gu Mi XiPatients in this arm receive Hou Gu Mi Xi, with an oral dose of 10 g/day during entire follow up period (2 years). |
| placebo | Placebo comparator | Other: placeboPatients in this arm receive placebo, with an oral dose of 10 g/day during entire follow up period (2 years). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hou Gu Mi XiHou 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. | Dietary supplement | Hou Gu Mi Xi |
| placeboThe placebo has same appearance, taste and smell as Hou Gu Mi Xi. | Other | placebo |
Primary outcome
Changes 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)
14 secondary outcomes
Qualitative assessment of changes in total scores of SQD scale from baseline
Time frame: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
Changes in scores of each item of SQD scale from baseline
Time frame: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
Changes from baseline in total scores of Short Form 36 (SF-36) (Units on a scale)
Time frame: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
Changes from baseline in scores of subitems in Short Form 36 (SF-36) (Units on a scale)
Time frame: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
Changes from baseline in scores of Eastern Cooperative Oncology Group (ECOG) Performance Status (Units on a scale)
Time frame: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
Progression free survival (month)
Time frame: From the first dose of intervention up to 104 weeks
Changes from baseline in systolic blood pressure (mmHg)
Time frame: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
Changes from baseline in diastolic blood pressure (mmHg)
Time frame: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
Changes from baseline in body weight (kg)
Time frame: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
Changes from baseline in body mass index (kg/m2)
Time frame: At baseline and 2, 4, 8, 26, 52, 78 and 104 weeks
Incidence of any adverse events
Time frame: From the first dose of intervention up to 104 weeks
Incidence of severe adverse events
Time frame: From the first dose of intervention up to 104 weeks
Incidence of drug-related adverse events
Time frame: From the first dose of intervention up to 104 weeks
Incidence of withdrawn due to adverse events
Time frame: From the first dose of intervention up to 104 weeks
Results and safety
The study was stopped early (reason given: High attrition rate up to 37.7% at one year's follow-up). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Background: PubMed 27433390Oh 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.
- Background: PubMed 16440411Yang 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.
- Background: PubMed 20845514Wu 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.
- Background: PubMed 15788127Yin 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.
- Background: PubMed 15361303Yin 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.
- Derived from this study: PubMed 31182140Zhou 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.
- Individual participant dataSharing planned: No. The investigators do not plan to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weifeng Zhu, Ph.D. study chair
Jiangxi University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hou Gu Mi Xi in people with Gastric Cancer and Gastrointestinal Disease, run by Jiangxi University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: High attrition rate up to 37.7% at one year's follow-up). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03025152, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.