Treatment of Functional Dyspepsia With Genuine Regional Rhizoma Atractylodis
Clinical Research on Treatment of Functional Dyspepsia With Genuine Regional Rhizoma Atractylodis: a Randomized Double-blind Placebo Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: genuine regional Rhizoma Atractylodis
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. |
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.
Other Names:
|
|
Active Comparator: non-genuine regional Rhizoma Atractylodis
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. |
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.
Other Names:
|
|
Placebo Comparator: placebo
placebo granules: Simulants (granule), 9g per bag, manufactured by Guangdong Yifang Pharmaceutical Group Co., Ltd., orally administration, 9g per time, 3 times a day.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
disappearance rate of dyspepsia
Time Frame: Eight weeks
|
The evaluation is divided into five levels: symptoms disappeared; significant improved; moderate improved, no change; deteriorated.
|
Eight weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The Short-Form Leeds Dyspepsia Questionnaire, SF-LDQ
Time Frame: Eight weeks
|
Eight weeks
|
|
Nepean Dyspepsia Index, NDI
Time Frame: Eight weeks
|
Eight weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yanming Xie, M.D., China Academy of Chinese Medical Sciences
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2060302-1401-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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