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Treatment of Functional Dyspepsia With Genuine Regional Rhizoma Atractylodis

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
genuine regional Rhizoma Atractylodis (Maozhu granule)
Sponsored by
China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Efficiency of Genuine Regional and Non-genuine Regional Rhizoma Atractylodis in Treating FD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    genuine regional Rhizoma Atractylodis

    non-genuine regional Rhizoma Atractylodis

    placebo

    Arm 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.

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    The Short-Form Leeds Dyspepsia Questionnaire, SF-LDQ
    Nepean Dyspepsia Index, NDI

    Full Information

    First Posted
    May 30, 2017
    Last Updated
    May 30, 2017
    Sponsor
    China Academy of Chinese Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03173183
    Brief Title
    Treatment of Functional Dyspepsia With Genuine Regional Rhizoma Atractylodis
    Official Title
    Clinical Research on Treatment of Functional Dyspepsia With Genuine Regional Rhizoma Atractylodis: a Randomized Double-blind Placebo Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2017 (Anticipated)
    Primary Completion Date
    August 2018 (Anticipated)
    Study Completion Date
    August 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    China Academy of Chinese Medical Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Efficiency of Genuine Regional and Non-genuine Regional Rhizoma Atractylodis in Treating FD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The research is designed by randomized, double-blind, placebo and parallel clinical control.
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    genuine regional Rhizoma Atractylodis
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    non-genuine regional Rhizoma Atractylodis
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    genuine regional Rhizoma Atractylodis (Maozhu granule)
    Other Intervention Name(s)
    non-genuine regional Rhizoma Atractylodis (Luozhu granule), placebo granules
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    disappearance rate of dyspepsia
    Description
    The evaluation is divided into five levels: symptoms disappeared; significant improved; moderate improved, no change; deteriorated.
    Time Frame
    Eight weeks
    Secondary Outcome Measure Information:
    Title
    The Short-Form Leeds Dyspepsia Questionnaire, SF-LDQ
    Time Frame
    Eight weeks
    Title
    Nepean Dyspepsia Index, NDI
    Time Frame
    Eight weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Meeting the FD Rome Ⅲ diagnosis standard; Meeting TCM differentiated diagnosis standard of the spleen deficiency with dampness pattern; Without taking any medicines affecting gastric motility in the recent 14 days; Between 18 and 65 years old; Voluntary participation in the trial and signing informed consent. Exclusion Criteria: 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. Patient whose differentiation is not clear or who doesn't belong to the spleen deficiency with dampness pattern. Women in pregnancy, breastfeeding or have fertility plans recently; the legally disabled (blind, deaf, dumb, mental retardation, mental disorders, physical disability) 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. Allergy to the trial drug. With suspected or definite alcohol, drug abuse history.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yin Zhang, M.D.
    Phone
    8617710830835
    Email
    coolzhangyin@sina.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yanming Xie, M.D.
    Organizational Affiliation
    China Academy of Chinese Medical Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Treatment of Functional Dyspepsia With Genuine Regional Rhizoma Atractylodis

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