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Clinical Study on Post Evaluation After Listing of Qizhi Weitong Granules

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ClinicalTrials.gov Identifier: NCT03149393
Recruitment Status : Not yet recruiting
First Posted : May 11, 2017
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
Xiyuan Hospital of China Academy of Chinese Medical Sciences

Brief Summary:
This study is a randomized, double blind, double dummy, multicenter, parallel controlled clinical trial, the investigators objective is to evaluate the efficacy and safety of Qizhi Weitong granules in the treatment of functional dyspepsia.

Condition or disease Intervention/treatment Phase
Functional Dyspepsia Traditional Chinese Medicine Drug: Qizhi Weitong Granules Drug: Mosapride Citrate Tablets Phase 1 Phase 2

Detailed Description:
This study is a randomized, double blind, double dummy, multicenter, parallel controlled clinical trial, the investigators objective is to evaluate the efficacy and safety of Qizhi Weitong granules in the treatment of functional dyspepsia. The experiment will be carried out in 8 sub centers at the same time, and the investigators estimated that there will be 384 cases of income, including the experimental group and the control group (n = 192), and the investigators choose mosapride citrate tablets for drug control.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 384 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Study on Post Evaluation After Listing of Qizhi Weitong Granules
Estimated Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
Experimental: Qizhi Weitong Granules Group
Patients in this group will take Qizhi Weitong Granules for 8 weeks.
Drug: Qizhi Weitong Granules
Patients in this group will take Qizhi Weitong Granules 2.5g,3 times/day,30 minutes before dinner for 8 weeks.
Other Name: The Treatment Group

Active Comparator: Mosapride Citrate Tablets Group
Patients in this group will take mosapride citrate tablets for 8 weeks.
Drug: Mosapride Citrate Tablets
Patients in this group will take mosapride citrate tablets 5mg,3 times/day,30 minutes before dinner for 8 weeks.
Other Name: The Control Group




Primary Outcome Measures :
  1. Change of Main Symptom Score [ Time Frame: The score will be assessed at baseline and 2 week, 4 week, 6 week. ]
    The Main Symptom Score contains evaluation of postprandial fullness discomfort, early satiety, epigastric pain, epigastric burning sensation and so on.


Secondary Outcome Measures :
  1. Change of the Hamilton Anxiety Scale and the Hamilton Depression Scale [ Time Frame: The score will be assessed at baseline and 2 week, 4 week, 6 week. ]
    To evaluate the changes of patients' mental and psychological status



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. Metting the diagnostic criteria of functional dyspepsia in Rome IV.
  2. The subjects were informed, and the subjects voluntarily signed informed consent.
  3. The subjects have reading ability.

Exclusion Criteria:

  1. Patients suffering from gastric ulcer, gastroscopy see bleeding and mucosal erosion, pathological examination showed atrophy of gastric mucosa, intestinal metaplasia or dysplasia.
  2. Patients with Hp infection positive.
  3. Patients with gastroesophageal reflux disease.
  4. Patients with digestive system organic lesions.
  5. The patient had a history of stomach or abdominal surgery.
  6. Patients had taken the relevant drugs in the past 2 weeks.
  7. Patients suffering from severe illness affecting survival.
  8. Pregnant or lactating women.
  9. Participating in clinical trials of other drugs.
  10. Long term using of sedative hypnotics.
  11. Suspected or true 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): NCT03149393


Contacts
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Contact: Wang F yun, PhD 13522657731 ext 0086 wfy811@163.com

Sponsors and Collaborators
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Investigators
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Study Director: Tang X dong, PhD Director of Xiyuan Hospital

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Responsible Party: Xiyuan Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03149393     History of Changes
Other Study ID Numbers: Digestion-05
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: May 11, 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

Keywords provided by Xiyuan Hospital of China Academy of Chinese Medical Sciences:
Functional Dyspepsia
Qizhi Weitong Granules
Traditional Chinese Medicine

Additional relevant MeSH terms:
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Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Citric Acid
Sodium Citrate
Mosapride
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs