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The goal of this clinical trial is evaluating the efficacy and safety of Lianxiaxiaopi Granules in participant population. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lianxiaxiaopi Granules | Experimental |
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| a simulated agent of Lianxiaxiaopi Granules | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lianxiaxiaopi Granules | Drug | The participants took orally 1 sachet of Lianxiaxiaopi Granules, 3 times a day for 8 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Postprandial distress syndrome response rate | Postprandial Distress Syndrome Response, the number of weeks in which the subject responded to the postprandial distress syndrome was greater than 50% of the weeks throughout the treatment period. Response week, if the two symptoms of postprandial fullness and discomfort and early satiety decreased by ≥50% compared with the baseline per week, the response week was calculated by the diary card score. | The end of Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| postprandial distress syndrome score change from baseline | "The dyspepsia symptom scoring criteria" consists of 5 items, with a minimum score of 0 and a maximum of 10 points for each item. 0 points: asymptomatic; 1-3 points: mild disturbance, mild symptoms, almost no impact on daily life and work; 4-6 points: moderate disturbance, still tolerable, partially affecting daily life and work; 7-10 points: Severe disturbance, unbearable, unable to carry out daily life and work. The minimum score of the scale is 0 points, the maximum is 50 points, and the higher the score, the more serious the disease. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peimin Feng, Doctor | Contact | 18981885791 | 76262251@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guang'anmen Hospital, China Academy of Chinese Medical Sciences | Not yet recruiting | Beijing | Beijing Municipality | China |
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| a simulated agent of Lianxiaxiaopi Granules | Drug | The participants took orally 1 sachet of simulated agent of Lianxiaxiaopi Granules, 3 times a day for 8 weeks. |
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| The end of Week 8 |
| single symptom response rate | The end of Week 8 |
| the change value of single symptom score from baseline | "The dyspepsia symptom scoring criteria" consists of 5 items, with a minimum score of 0 and a maximum of 10 points for each item. 0 points: asymptomatic; 1-3 points: mild disturbance, mild symptoms, almost no impact on daily life and work; 4-6 points: moderate disturbance, still tolerable, partially affecting daily life and work; 7-10 points: Severe disturbance, unbearable, unable to carry out daily life and work. | The end of Week 8 |
| the change from baseline in epigstric pain syndrome score | "The dyspepsia symptom scoring criteria" consists of 5 items, with a minimum score of 0 and a maximum of 10 points for each item. 0 points: asymptomatic; 1-3 points: mild disturbance, mild symptoms, almost no impact on daily life and work; 4-6 points: moderate disturbance, still tolerable, partially affecting daily life and work; 7-10 points: Severe disturbance, unbearable, unable to carry out daily life and work. The score for epigastric pain syndrome includes the sum of the scores for mid-upper quadrant pain and mid-upper quadrant burning sensation | The end of Week 8 |
| epigastric pain syndrome response rate | The end of Week 8 |
| the change from baseline in the total score of TCM | The TCM Syndrome Scale for Postprandial Distress Syndrome contains two main symptoms, each of which can be evaluated as 0, 2, 4 and 6 points. 6 sub-symptoms, each of which can be evaluated as 0, 1, 2, and 3 points. The scale has a minimum score of 0 and a maximum of 30 points, with the higher the score, the more severe the condition. | The end of Week 8 |
| the change value of TCM single symptom score from baseline | The TCM Syndrome Scale for Postprandial Distress Syndrome contains two main symptoms, each of which can be evaluated as 0, 2, 4 and 6 points. 6 sub-symptoms, each of which can be evaluated as 0, 1, 2, and 3 points. The scale has a minimum score of 0 and a maximum of 30 points, with the higher the score, the more severe the condition. | The end of Week 8 |
| TCM syndrome integral effective rate | Recovery: Symptoms and signs disappear or basically disappear, and the score reduction rate of the syndrome ≥95%; Effective: Symptoms and signs improved, and the score reduction rate of the syndrome was ≥50%; Ineffective: no significant improvement in symptoms and signs, and the score reduction rate of the syndrome <50%. Recovery: Symptoms and signs disappear or basically disappear, and the score reduction rate of the syndrome ≥95%; Effective: Symptoms and signs improved, and the score reduction rate of the syndrome was ≥50%; Ineffective: no significant improvement in symptoms and signs, and the score reduction rate of the syndrome <50%. Recovery: Symptoms and signs disappear or basically disappear, and the score reduction rate of the syndrome ≥95%; Effective: Symptoms and signs improved, and the score reduction rate of the syndrome was ≥50%; Ineffective: no significant improvement in symptoms and signs, and the score reduction rate of the syndrome <50%. | The end of Week 8 |
| the grade change of TCM single symptom from baseline | The TCM Syndrome Scale for Postprandial Distress Syndrome contains two main symptoms, each of which can be evaluated as 0, 2, 4 and 6 points. 6 sub-symptoms, each of which can be evaluated as 0, 1, 2, and 3 points. The scale has a minimum score of 0 and a maximum of 30 points, with the higher the score, the more severe the condition. | The end of Week 8 |
| the proportion of subjects with sustained remission and no exacerbation of single symptoms at 12W compared with 8W | There are 5 items in the Likert scale, with a minimum score of 1 and a maximum of 7 points for each item. The scale has a minimum score of 0 and a maximum of 35 points, with higher scores and more severe conditions. Among them, the subjects selected (1) and (2) are defined as having sustained remission from treatment; Subjects selected (3) and (4) were defined as having no exacerbation of disease; Subjects selected (5), (6), and (7) were defined as having exacerbated disease. | The end of Week 12 |
| Gansu Provincial Hospital of Traditional Chinese Medicine | Not yet recruiting | Lanzhou | Gansu | China |
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| The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine | Not yet recruiting | Guiyang | Guizhou | China |
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| Hebei Provincial Hospital of Traditional Chinese Medicine | Not yet recruiting | Shijiazhuang | Hebei | China |
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| The Second Affiliated Hospital of Xingtai Medical College | Not yet recruiting | Xingtai | Hebei | China |
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| Baoding No. 1 Hospital of Traditional Chinese Medicine | Not yet recruiting | Baoding | Heibei | China |
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| The First People's Hospital of Luoyang City | Recruiting | Luoyang | Henan | China |
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| The Affiliated Hospital of Changchun University of Traditional Chinese Medicine | Not yet recruiting | Changchun | Jilin | China |
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| General Hospital of the Northern Theater of the Chinese People's Liberation Army | Not yet recruiting | Shenyang | Liaoning | China |
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| The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine | Not yet recruiting | Shenyang | Liaoning | China |
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| Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine | Not yet recruiting | Shanghai | Shanghai Municipality | China |
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| The Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine | Not yet recruiting | Xianyang | Shanxi | China |
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| The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine | Recruiting | Chengdu | Sichuan | China |
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| West China Hospital Sichuan University | Not yet recruiting | Chengdu | Sichuan | China |
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| The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine | Not yet recruiting | Tianjin | Tianjin Municipality | China |
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| The First Affiliated Hospital of Kunming Medical University | Not yet recruiting | Kunming | Yunnan | China |
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| Zhejiang Provincial Hospital of Traditional Chinese Medicine | Not yet recruiting | Hangzhou | Zhejiang | China |
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| Wenzhou Hospital of Traditional Chinese Medicine | Not yet recruiting | Wenzhou | Zhejiang | China |
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