Efficiency of Genuine Regional and Non-genuine Regional Rhizoma Atractylodis in Treating FD
Conditions
Brief summary
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.
Interventions
DRUGgenuine regional Rhizoma Atractylodis (Maozhu granule)
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.
Sponsors
China Academy of Chinese Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
The research is designed by randomized, double-blind, placebo and parallel clinical control.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Meeting the FD Rome Ⅲ diagnosis standard; 2. Meeting TCM differentiated diagnosis standard of the spleen deficiency with dampness pattern; 3. Without taking any medicines affecting gastric motility in the recent 14 days; 4. Between 18 and 65 years old; 5. Voluntary participation in the trial and signing informed consent.
Exclusion criteria
1. 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. 2. Patient whose differentiation is not clear or who doesn't belong to the spleen deficiency with dampness pattern. 3. Women in pregnancy, breastfeeding or have fertility plans recently; the legally disabled (blind, deaf, dumb, mental retardation, mental disorders, physical disability) 4. 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. 5. Allergy to the trial drug. 6. With suspected or definite alcohol, drug abuse history.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disappearance rate of dyspepsia | Eight weeks | The evaluation is divided into five levels: symptoms disappeared; significant improved; moderate improved, no change; deteriorated. |
Secondary
| Measure | Time frame |
|---|---|
| The Short-Form Leeds Dyspepsia Questionnaire, SF-LDQ | Eight weeks |
| Nepean Dyspepsia Index, NDI | Eight weeks |
Contacts
Primary ContactYin Zhang, M.D.
Outcome results
None listed