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Treatment of Functional Dyspepsia With Genuine Regional Rhizoma Atractylodis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03173183
Recruitment Status : Unknown
Verified May 2017 by Yanming Xie, China Academy of Chinese Medical Sciences.
Recruitment status was:  Not yet recruiting
First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
Yanming Xie, 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.

Condition or disease Intervention/treatment Phase
Efficiency of Genuine Regional and Non-genuine Regional Rhizoma Atractylodis in Treating FD Drug: genuine regional Rhizoma Atractylodis (Maozhu granule) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The research is designed by randomized, double-blind, placebo and parallel clinical control.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Research on Treatment of Functional Dyspepsia With Genuine Regional Rhizoma Atractylodis: a Randomized Double-blind Placebo Controlled Trial
Estimated Study Start Date : August 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

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.

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.

Other Names:
  • non-genuine regional Rhizoma Atractylodis (Luozhu granule)
  • placebo granules

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.

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.

Other Names:
  • non-genuine regional Rhizoma Atractylodis (Luozhu granule)
  • placebo granules

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.
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.

Other Names:
  • non-genuine regional Rhizoma Atractylodis (Luozhu granule)
  • placebo granules




Primary Outcome Measures :
  1. disappearance rate of dyspepsia [ Time Frame: Eight weeks ]
    The evaluation is divided into five levels: symptoms disappeared; significant improved; moderate improved, no change; deteriorated.


Secondary Outcome Measures :
  1. The Short-Form Leeds Dyspepsia Questionnaire, SF-LDQ [ Time Frame: Eight weeks ]
  2. Nepean Dyspepsia Index, NDI [ Time Frame: Eight weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03173183


Contacts
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Contact: Yin Zhang, M.D. 8617710830835 coolzhangyin@sina.com

Sponsors and Collaborators
China Academy of Chinese Medical Sciences
Investigators
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Principal Investigator: Yanming Xie, M.D. China Academy of Chinese Medical Sciences

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Responsible Party: Yanming Xie, Executive director, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03173183     History of Changes
Other Study ID Numbers: 2060302-1401-03
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms