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
|Condition or disease||Intervention/treatment||Phase|
|Functional Dyspepsia Traditional Chinese Medicine||Drug: Qizhi Weitong Granules Drug: Mosapride Citrate Tablets||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||384 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149393
|Contact: Wang F yun, PhD||13522657731 ext firstname.lastname@example.org|
|Study Director:||Tang X dong, PhD||Director of Xiyuan Hospital|