Treatment of Functional Dyspepsia With Genuine Regional Rhizoma Atractylodis

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Research on Treatment of Functional Dyspepsia With Genuine Regional Rhizoma Atractylodis: a Randomized Double-blind Placebo Controlled Trial

Conditions
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Efficiency of Genuine Regional and Non-genuine Regional Rhizoma Atractylodis in Treating FD

Intervention / Treatment
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* Drug: genuine regional Rhizoma Atractylodis (Maozhu granule)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meeting the FD Rome Ⅲ diagnosis standard; Meeting TCM differentiated diagnosis standard of the spleen deficiency with dampness pattern; Without taking any medicines affecting gastric motility in the recent 14 days; Between 18 and 65 years old; Voluntary participation in the trial and signing informed consent. Exclusion Criteria: Combined irritable bowel syndromes; combined peptic ulcer, erosive gastritis, atrophic gastritis, abdominal surgery history, gastric mucosa with severe dysplasia or pathological diagnosis of suspected malignant transformation; combined gastroesophageal reflux disease, irritable bowel syndrome with overlapping syndromes. Patient whose differentiation is not clear or who doesn't belong to the spleen deficiency with dampness pattern. Women in pregnancy, breastfeeding or have fertility plans recently; the legally disabled (blind, deaf, dumb, mental retardation, mental disorders, physical disability) Patients with endocrine and metabolic diseases such as connective tissue diseases, diabetes, menopausal syndromes; patients combined with heart rate disorder, severe diseases in cardiovascular, brain, liver, lung, kidney and hematopoietic systems, acute and chronic infectious diseases, malignant tumors, mental illness. Allergy to the trial drug. With suspected or definite alcohol, drug abuse history.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The research is designed by randomized, double-blind, placebo and parallel clinical control.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: genuine regional Rhizoma Atractylodis<br>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. | Drug: genuine regional Rhizoma Atractylodis (Maozhu granule)<br>* 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.<br>* Other names: placebo granules;|
| Active Comparator: non-genuine regional Rhizoma Atractylodis<br>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. | Drug: genuine regional Rhizoma Atractylodis (Maozhu granule)<br>* 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.<br>* Other names: placebo granules;|
| Placebo Comparator: placebo<br>placebo granules: Simulants (granule), 9g per bag, manufactured by Guangdong Yifang Pharmaceutical Group Co., Ltd., orally administration, 9g per time, 3 times a day. | Drug: genuine regional Rhizoma Atractylodis (Maozhu granule)<br>* 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.<br>* Other names: placebo granules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Short-Form Leeds Dyspepsia Questionnaire, SF-LDQ |  | Eight weeks | 
| Nepean Dyspepsia Index, NDI |  | Eight weeks |