Treatment of Functional Dyspepsia With Genuine Regional Rhizoma Atractylodis

Not Applicable

• Conditions: Efficiency of Genuine Regional and Non-genuine Regional Rhizoma Atractylodis in Treating FD
• Interventions: Drug: genuine regional Rhizoma Atractylodis (Maozhu granule)

• Registration Number: NCT03173183
• Lead Sponsor: China Academy of Chinese Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-30
• Study First Submitted QC: 2017-05-30
• Last Update Submitted: 2017-05-30
• Study First Posted: 2017-06-01
• Last Update Posted: 2017-06-01
• Study Start: 2017-08
• Primary Completion: 2018-08
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
genuine regional Rhizoma Atractylodis	genuine regional Rhizoma Atractylodis (Maozhu granule)	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.
non-genuine regional Rhizoma Atractylodis	genuine regional Rhizoma Atractylodis (Maozhu granule)	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.
placebo	genuine regional Rhizoma Atractylodis (Maozhu granule)	placebo granules: Simulants (granule), 9g per bag, manufactured by Guangdong Yifang Pharmaceutical Group Co., Ltd., orally administration, 9g per time, 3 times a day.

Primary Outcome Measures

Name	Time	Method
disappearance rate of dyspepsia	Eight weeks	The evaluation is divided into five levels: symptoms disappeared; significant improved; moderate improved, no change; deteriorated.

Secondary Outcome Measures

Name	Time	Method
The Short-Form Leeds Dyspepsia Questionnaire, SF-LDQ	Eight weeks
Nepean Dyspepsia Index, NDI	Eight weeks