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This is a randomized double-blind placebo controlled trial aim to compare the efficiency of genuine regional and non-genuine regional Rhizoma Atractylodis in treating functional dyspepsia. This study will also observe the clinical safety of genuine regional Rhizoma Atractylodis.The trial will be conducted in Xiyuan Hospital of China Academy of Chinese Medicine Sciences and Dongzhimen Hospital of Beijing University of Chinese Medicine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| genuine regional Rhizoma Atractylodis | Experimental | Granules of genuine regional Rhizoma Atractylodis: Maozhu granule, 9g per bag, manufactured by Guangdong Yifang Pharmaceutical Co., Ltd., orally administration, 9g per time, 3 times a day. |
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| non-genuine regional Rhizoma Atractylodis | Active Comparator | Granules of non-genuine regional Rhizoma Atractylodis (Luotian, Hubei province) : Luozhu granule, 9g per bag, manufactured by Guangdong Yifang Pharmaceutical Co., Ltd., orally administration, 9g per time, 3 times a day. |
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| placebo | Placebo Comparator | placebo granules: Simulants (granule), 9g per bag, manufactured by Guangdong Yifang Pharmaceutical Group Co., Ltd., orally administration, 9g per time, 3 times a day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| genuine regional Rhizoma Atractylodis (Maozhu granule) | Drug | Maozhu granule, 9g per bag, manufactured by Guangdong Yifang Pharmaceutical Co., Ltd. Luozhu granule, 9g per bag, manufactured by Guangdong Yifang Pharmaceutical Co., Ltd. Simulants (granule), 9g per bag, manufactured by Guangdong Yifang Pharmaceutical Group Co., Ltd. |
| Measure | Description | Time Frame |
|---|---|---|
| disappearance rate of dyspepsia | The evaluation is divided into five levels: symptoms disappeared; significant improved; moderate improved, no change; deteriorated. | Eight weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Short-Form Leeds Dyspepsia Questionnaire, SF-LDQ | Eight weeks | |
| Nepean Dyspepsia Index, NDI | Eight weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yin Zhang, M.D. | Contact | 8617710830835 | coolzhangyin@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Yanming Xie, M.D. | China Academy of Chinese Medical Sciences | Principal Investigator |
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The research is designed by randomized, double-blind, placebo and parallel clinical control.
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