Treatment of Functional Dyspepsia With Genuine Regional Rhizoma Atractylodis

China Academy of Chinese Medical Sciences

Status: Unknown

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

Treatments: Drug: genuine regional Rhizoma Atractylodis (Maozhu granule)

Study type: Interventional

Funder types: Other

Identifiers

NCT03173183

2060302-1401-03

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

genuine regional Rhizoma Atractylodis

Experimental group

Description:

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.

Treatment:

Drug: genuine regional Rhizoma Atractylodis (Maozhu granule)

non-genuine regional Rhizoma Atractylodis

Active Comparator group

Description:

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.

Treatment:

Drug: genuine regional Rhizoma Atractylodis (Maozhu granule)

placebo

Placebo Comparator group

Description:

placebo granules: Simulants (granule), 9g per bag, manufactured by Guangdong Yifang Pharmaceutical Group Co., Ltd., orally administration, 9g per time, 3 times a day.

Treatment:

Drug: genuine regional Rhizoma Atractylodis (Maozhu granule)