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| Name | Class |
|---|---|
| The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine | OTHER |
| Wuhan Integrated TCM and Western Medicine Hospita | UNKNOWN |
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Functional dyspepsia (FD), which is one of the most common gastrointestinal disorders with high disease burden. Postprandial distress syndrome (PDS) is a common subtype of FD. Although the effectiveness of Chinese herbal formula of Xiang-sha-liu-jun granule (XSLJG) for alleviating PDS symptoms has been assessed in previous studies, more convinced evidence of randomized placebo-controlled study is needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | Participants will orally take the placebo granules 12g twice a day for 4 weeks. No other interventions during the study period will be allowed. |
|
| Xiang-sha-liu-jun granules | Active Comparator | Participants will orally take the herbal formula granules 12g twice a day for 4 weeks. No other interventions during the study period will be allowed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug |
| ||
| Xiang-sha-liu-jun granules |
| Measure | Description | Time Frame |
|---|---|---|
| change of postprandial discomfort severity Scale | Postprandial Discomfort Severity Scale at baseline, 2 weeks, and 4 weeks during oral administration of medicine |
| Measure | Description | Time Frame |
|---|---|---|
| global impression scale | global impression scale at baseline, 2 weeks, and 4 weeks during oral administration of medicine | |
| SF-36 questionnaire | SF-36 questionnaire at baseline, 2 weeks, and 4 weeks during oral administration of medicine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xudong Tang, Ph.D | Contact | +86-10-62835001 | txdly@sina.com | |
| fengyun Wang, Ph.D | Contact | +86-10-62835001 | wfy811@163.com |
| Name | Affiliation | Role |
|---|---|---|
| xudong Tang, Ph.D | xi yuan hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the first hospital affiliated to Guangzhou university of Chinese medicine | Recruiting | Guangzhou | Guangdong | 510405 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31011363 | Derived | Zhang J, Wang X, Shi X, Xie J, Zhang M, Ma J, Wang F, Tang X. Combination of 15 lipid metabolites and motilin to diagnose spleen-deficiency FD. Chin Med. 2019 Apr 15;14:16. doi: 10.1186/s13020-019-0238-9. eCollection 2019. |
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The Xiang-sha-liu-jun granules comprises 10 herbs, Astragalus membranaceus (Huangqi) 15g, Codonopsis pilosula (Dangshen) 15 g, fructus aurantii (Zhiqiao) 15g, fructus amomi(Sharen) etc |
|
| gastric emptying | Gastric emptying is related with several hormones such as CCK and ghrelin. | gastric emptying will be assessed at baseline and 4 weeks during oral administration of medicine |
| Wuhan integrated TCM and western medicine hospital | Recruiting | Wuhan | Hubei | 430022 | China |
|