Treatment of Functional Dyspepsia With Genuine Regional Rhizoma Atractylodis

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

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03173183
• Other study ID #: 2060302-1401-03
• Status: Not yet recruiting
• Phase: N/A
• First received: May 30, 2017
• Last updated: May 30, 2017
• Start date: August 2017
• Est. completion date: August 2018

Study information

• Verified date: May 2017
• Source: China Academy of Chinese Medical Sciences
• Contact: Yin Zhang, M.D.
• Phone: 8617710830835
• Email: coolzhangyin[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Meeting the FD Rome ? 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• genuine 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disappearance rate of dyspepsia	The evaluation is divided into five levels: symptoms disappeared; significant improved; moderate improved, no change; deteriorated.	Eight weeks
Secondary	The Short-Form Leeds Dyspepsia Questionnaire, SF-LDQ		Eight weeks
Secondary	Nepean Dyspepsia Index, NDI		Eight weeks