International Clinical Study of Zhizhu Kuanzhong Capsule
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|ClinicalTrials.gov Identifier: NCT03825692|
Recruitment Status : Not yet recruiting
First Posted : January 31, 2019
Last Update Posted : February 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Functional Dyspepsia Postprandial Distress Syndrome||Drug: Zhizhu Kuanzhong Capsule Drug: Zhizhu Kuanzhong Placebo Capsule||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||480 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, double-blind, placebo-controlled, multi-center|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multi-center, Randomized, Double-Blind, Placebo-Controlled Parallel Group Clinical Trial of Zhizhu Kuanzhong Capsule in Treating Patients With Postprandial Distress Syndrome of Functional Dyspepsia|
|Estimated Study Start Date :||March 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Zhizhu Kuanzhong Capsule
Zhizhu Kuanzhong Capsule Arm is Zhizhu Kuanzhong Capsule, Specification: 0.43 g/granule; Manufacturer: Lonch Group, Shuangren Pharmaceutical Co., Ltd. ; Approval number: NMPA approval number: GUOYAOZHUNZI Z20020003; Dosage and administration: 3 capsules at a time, 3 times a day, taken orally 10-15 min before meals
Drug: Zhizhu Kuanzhong Capsule
Zhizhu Kuanzhong Capsule, 3 capsules at a time, 3 times a day, taken orally 10-15 min before meals. an 8-week intervention period
Other Name: ZZKZ capsule
Placebo Comparator: Zhizhu Kuanzhong Placebo Capsule
Zhizhu Kuanzhong Placebo Capsule Arm is Zhizhu Kuanzhong Capsule Mimics composed of microcrystalline cellulose, mannitol and magnesium stearate, which used for filling agent and lubricant respectively; Specification: 0.43 g/granule; Manufacturer: Lonch Group, Shuangren Pharmaceutical Co., Ltd.; Dosage and administration: Be identical with the investigational drug.
Drug: Zhizhu Kuanzhong Placebo Capsule
Placebo, 3 capsules at a time, 3 times a day, taken orally 10-15 min before meals. an 8-week intervention period
Other Name: placebo
- The proportion of the response at 8 weeks after randomization [ Time Frame: up to 8 weeks ]Subjects with the functional dyspepsia-postprandial distress syndrome are self-rated on the Visual Analogue Score (VAS) which is a scale of 0-10, with subjects indicating the degree of discomfort on a 10 cm ruler marked 0- "Asymptomatic or No Discomfort "to 10- "Extreme Severe or Extreme Discomfort "at its head and tail, respectively. The record is made once a day and 7 days a week via a diary card. For VAS scores for postprandial fullness discomfort and early satiety, the integral average for both symptoms over the past week is evaluated, and a 50% decrease from baseline in the integral average at 8 Weeks is recorded as a response.
- The change of VAS score of each symptom of functional dyspepsia [ Time Frame: Up to 8 weeks ]On the diary cards, subjects recorded the Visual Analogue Score (VAS) of each symptom of the functional dyspepsia daily. VAS is scored on a scale of 0-10 which the higher the score, the severer the symptom is. The record is made once a day and 7 days. The investigators use the average of the weekly VAS scores as the symptom intensity score for this week, with one VAS score per week. The change in the score of each symptom at 8 weeks after randomization relative to the baseline is evaluated.
- Overall treatment response rate [ Time Frame: Up to 8 weeks ]The overall treatment efficacy is evaluated using a 7-point Likert Overall Evaluation Scale (OTE). The clinical investigators asked the subjects the following questions weekly: "In the last week, how much have your dyspeptic symptoms been alleviated as compared to pre-treatment? " There are 7 options: ① the symptoms improved significantly, ② the symptoms improved, ③ the symptoms improved slightly, ④ the symptoms did not change, ⑤ the symptoms aggravated slightly, ⑥ the symptoms aggravated, ⑦ the symptoms aggravated significantly. At the last visit time point of the treatment cycle, patients who selected ① and ② were defined as treatment responders, and those who selected ③—⑦ were defined as non-responders. The response rate at 8 weeks after randomization between the groups are compared for differences.
- Short Form Nepean Dyspepsia Index (SFNDI) [ Time Frame: Up to 8 weeks ]Short Form-Nepean Dyspepsia Index (SFNDI) is a reliable and valid measure of quality of life in functional dyspepsia with 10 items which questions are about how subjects stomach pain, discomfort, or other epigastric symptoms over the last 14 days affect their lives. Add up the ten items for each of the five sub‐scale scores (range of each sub‐scale 2-10). The changes of SFNDI score at 4 weeks and 8 weeks after randomization relative to the baseline are calculated.
- Hospital Anxiety and Depression Scale score [ Time Frame: Up to 8 weeks ]The Hospital Anxiety and Depression Scale (HAD) is mainly used in patients in general hospitals which provides two sets of tests to assess the state of anxiety and depression, respectively. Among them, A stands for anxiety items, D stands for depression items, and each item is scored at four levels. Each of the two sets of items are superimposed to obtain their respective total score. A total score of 0 to 7 indicates normal, 8 to 10 indicates borderline abnormal, and 11 to 21 indicates abnormal. The changes of HAD score at 4 weeks and 8 weeks after randomization relative to the baseline are calculated.
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): NCT03825692
|Contact: Fang Lu, MD,Phdemail@example.com|
|Contact: Yingpan Zhao, MD,Phdfirstname.lastname@example.org|
|Study Director:||Fang Lu, Md, Phd||Xiyuan Hospital of China Academy of Chinese Medical Sciences|