Back to resultsZhizhu Kuanzhong Capsule for Patients With Functional Dyspepsia-Postprandial Distress Syndrome (ZZKZ-FD)
Primary Purpose
Functional Dyspepsia
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Investigational drug for Functional Dyspepsia-Postprandial Distress Syndrome
Placebo capsules
Sponsored by
About this trial
This is an interventional treatment trial for Functional Dyspepsia
Eligibility Criteria
Inclusion Criteria:
- Meeting the Rome IV diagnostic criteria for functional dyspepsia-postprandial distress syndrome;
- At least 3 days during the one-week run-in period with VAS score ≥ 4 for major symptoms (at least one of postprandial fullness discomfort and early satiety) .
- Be able to discontinue prohibited medications that may affect the evaluation of the effectiveness.
- Written informed consent.
Exclusion Criteria:
- Gastroscopic findings of gastric cancer, peptic ulcer, erosive gastritis (grade 2 or higher), moderate to severe atrophic gastritis, dysplasia, or other organ gastrointestinal disease.
- History of abdominal surgery (except for appendectomy and cesarean section);
- Immune system defects, or those who have been administered immunosuppressive agents or glucocorticoids within the past 3 months.
- With combined severe cardiac and pulmonary insufficiency, insufficiency of liver (ALT/AST > 1.5 times the upper limit of the normal value), kidney insufficiency (BUN/SCr > the upper limit of the normal value), abnormal of endocrine system, abnormal hematopoietic system, and iron deficiency anemia as indicated on hematological examination.
- With severe anxiety and depression.
- With psychosis and mental retardation, language disorder precluding the ability of filling scales or recording symptoms.
- Pregnancy or lactating; or patients of childbearing potential without effective contraception.
- known to be allergic to the ingredients of this drug.
- suspected or confirmed history of alcohol or drug abuse.
- have participated in a clinical trial in the past 3 months.
- deemed by the investigator as being not suitable for participation in the clinical trial.
Sites / Locations
- Linda ZhongRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Investigational Drug Group
Placebo Group
Arm Description
A 8-weeks double-blind treatment period with a Proprietary Chinese Medicine (consists of 4 kinds of Chinese herbs at 0.43g/capsule in weight), 3 capsules at one time, 3 times a day, oral administration 10-15 minutes before meals
A 8-weeks double-blind treatment period with Placebo Capsules (at 0.43g/capsule in weight), 3 capsules at one time, 3 times a day, oral administration 10-15 minutes before meals
Outcomes
Primary Outcome Measures
Visual Analogue Score (VAS)
Subjects with the functional dyspepsia-postprandial distress syndrome are self-rated on the Visual Analogue Score (VAS) for the degree of discomfort with both symptoms of postprandial fullness and early fullness, with subjects indicating the degree of discomfort on a 10 cm ruler marked 0- "Asymptomatic or No Discomfort "and 10- "Extreme Severe or Extreme Discomfort "at its head and tail, respectively. The record is made on the diary card once a day and 7 days a week.
The integral average for the sum of VAS for both two symptoms over the past week is evaluated based on the diary card content, and a 50% decrease from baseline in the integral average at 8 weeks is recorded as a response. The proportion of the response at 8 weeks after randomization is considered primary efficacy endpoint.
Secondary Outcome Measures
Evaluation of individual symptoms of Functional Dyspepsia
The subjects were evaluated using a symptom diary for Functional Dyspepsia based on the Visual Analogue Score (VAS) for gastrointestinal symptoms, including postprandial fullness discomfort, early satiety, abdominal distension, abdominal pain, epigastric burning sensation, nausea, excessive eructation, heartburn, vomiting, regurgitation, dysphagia, rass, abdominal enlargement, and defecation smoothness. Subjects indicated their discomfort on a 10 cm ruler marked 0-"asymptomatic or no discomfort" and 10-"very painful or extremely uncomfortable" on the head and tail respectively. The rating is made once a day and 7 days a week. The investigator used the average of the weekly VAS scores recorded in the subject's diary card as the symptom intensity score for this week, with one VAS score per week. The change of VAS score of each symptom at 8 weeks after randomization relative to the base
Overall Treatment Evaluation scale (OTE)
The overall treatment efficacy is evaluated using a 7point Likert Overall Evaluation Scale (OTE). The clinical investigators asked the subjects the following questions at the visit: "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 -② were defined as treatment responders, and those who selected ③ -⑦ were defined as non-responders. The response rates at 8 weeks between the groups were compared for differences.
Hospital Anxiety and Depression Scale (HAD) score
HAD Rating Scale scores are recorded at baseline, week 4 and week 8 during the double-blind treatment respectively. 14 questions are asked about the subject's emotional changes that best match his/her mood since the last month.
Short Form-Nepean Dyspepsia Index (SFNDI)
Short Form-Nepean Dyspepsia Index (SFNDI) is recorded at baseline, week 4 and week 8 during the double-blind treatment respectively. 10 Questions are asked about how the subject's stomach pain, discomfort, or other epigastric symptoms over the last 14 days have affected his/her life.
Full Information
NCT ID
NCT04380233
First Posted
May 5, 2020
Last Updated
March 2, 2022
Sponsor
Hong Kong Baptist University
Collaborators
Xiyuan Hospital of China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04380233
Brief Title
Zhizhu Kuanzhong Capsule for Patients With Functional Dyspepsia-Postprandial Distress Syndrome
Acronym
ZZKZ-FD
Official Title
A Multi-center, Randomized, Double-Blind, Placebo-Controlled Parallel Group Clinical Research of Zhizhu Kuanzhong Capsule in Treating Patients With Functional Dyspepsia-Postprandial Distress Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Anticipated)
Study Completion Date
March 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hong Kong Baptist University
Collaborators
Xiyuan Hospital of 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
A 13 weeks randomized, double-blind and placebo parallel-controlled trial will be conducted to evaluate the clinical efficacy and safety of Zhizhu Kuanzhong Capsule in the treatment of functional dyspepsia-postprandial distress syndrome.
Detailed Description
This is a multi-center, randomized, double-blind, placebo parallel-controlled International clinical trial of Zhizhu Kuanzhong Capsule in treating patients with Functional Dyspepsia-Postprandial Distress Syndrome (FD-PDS).
In this study, Hong Kong Baptist University will collaborate with Xiyuan Hospital of China Academy of Chinese Medical Sciences, and will be recruiting 60 FD-PDS patients as study subjects in Hong Kong, out of the total sample size of 480 patients.
The study includes a 1 week run-in period, 8 weeks double-blind treatment period and a 4 weeks of follow up period for each eligible subject. Eligible subjects will be randomly assigned to either the trial drug or the placebo.
6 follow-up visits and 1 telephone follow-up will be scheduled for each subject on the -7 days (visit 1), enrollment on day 0 (visit 2), 14th day (visit 3), 28th day (visit 4), 42nd day (visit 5, telephone follow-up), the 56th day (visit 6) and the 84th day (visit 7) respectively.
Urine, stool and blood samples will be collected from each subject on visit 2 and visit 6 for blood, urine, stool, liver and kidney function tests.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Double-Blind, Placebo-Controlled Parallel Group Clinical Trial
Masking
ParticipantCare ProviderInvestigator
Masking Description
The eligible subjects will be randomly assigned, with equal access to either the Chinese medicine treatment investigational drug group (Zhizhu Kuanzhong Capsule) or the placebo group.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Investigational Drug Group
Arm Type
Experimental
Arm Description
A 8-weeks double-blind treatment period with a Proprietary Chinese Medicine (consists of 4 kinds of Chinese herbs at 0.43g/capsule in weight), 3 capsules at one time, 3 times a day, oral administration 10-15 minutes before meals
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
A 8-weeks double-blind treatment period with Placebo Capsules (at 0.43g/capsule in weight), 3 capsules at one time, 3 times a day, oral administration 10-15 minutes before meals
Intervention Type
Drug
Intervention Name(s)
Investigational drug for Functional Dyspepsia-Postprandial Distress Syndrome
Other Intervention Name(s)
Zhizhu Kuanzhong Capsule
Intervention Description
The investigational drug is a new pure type of gastrointestinal function modulator traditional Chinese medicine, composed of 4 kinds of Chinese herbs: Rhizoma Atractylodis Macrocephalae, Fructus Aurantii Immaturus, Radix Bupleuri and Fructus Crataegi. The preliminary clinical trial showed that it has a good therapeutic effect on FD patients, its Fructus Aurantii Immaturus promotes gastric emptying by stimulating the cells to release motilin, thereby significantly improving patients' symptoms of fullness, epigastric pain, eructation, and nausea and vomiting.
Intervention Type
Drug
Intervention Name(s)
Placebo capsules
Other Intervention Name(s)
Study drug
Intervention Description
The placebo consist of mainly starch and microcrystalline cellulose, the usage and dosage are the same as the investigational drug.
Primary Outcome Measure Information:
Title
Visual Analogue Score (VAS)
Description
Subjects with the functional dyspepsia-postprandial distress syndrome are self-rated on the Visual Analogue Score (VAS) for the degree of discomfort with both symptoms of postprandial fullness and early fullness, with subjects indicating the degree of discomfort on a 10 cm ruler marked 0- "Asymptomatic or No Discomfort "and 10- "Extreme Severe or Extreme Discomfort "at its head and tail, respectively. The record is made on the diary card once a day and 7 days a week.
The integral average for the sum of VAS for both two symptoms over the past week is evaluated based on the diary card content, and a 50% decrease from baseline in the integral average at 8 weeks is recorded as a response. The proportion of the response at 8 weeks after randomization is considered primary efficacy endpoint.
Time Frame
For 8 weeks
Secondary Outcome Measure Information:
Title
Evaluation of individual symptoms of Functional Dyspepsia
Description
The subjects were evaluated using a symptom diary for Functional Dyspepsia based on the Visual Analogue Score (VAS) for gastrointestinal symptoms, including postprandial fullness discomfort, early satiety, abdominal distension, abdominal pain, epigastric burning sensation, nausea, excessive eructation, heartburn, vomiting, regurgitation, dysphagia, rass, abdominal enlargement, and defecation smoothness. Subjects indicated their discomfort on a 10 cm ruler marked 0-"asymptomatic or no discomfort" and 10-"very painful or extremely uncomfortable" on the head and tail respectively. The rating is made once a day and 7 days a week. The investigator used the average of the weekly VAS scores recorded in the subject's diary card as the symptom intensity score for this week, with one VAS score per week. The change of VAS score of each symptom at 8 weeks after randomization relative to the base
Time Frame
For 8 weeks
Title
Overall Treatment Evaluation scale (OTE)
Description
The overall treatment efficacy is evaluated using a 7point Likert Overall Evaluation Scale (OTE). The clinical investigators asked the subjects the following questions at the visit: "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 -② were defined as treatment responders, and those who selected ③ -⑦ were defined as non-responders. The response rates at 8 weeks between the groups were compared for differences.
Time Frame
For 8 weeks
Title
Hospital Anxiety and Depression Scale (HAD) score
Description
HAD Rating Scale scores are recorded at baseline, week 4 and week 8 during the double-blind treatment respectively. 14 questions are asked about the subject's emotional changes that best match his/her mood since the last month.
Time Frame
At baseline, week 4 and week 8
Title
Short Form-Nepean Dyspepsia Index (SFNDI)
Description
Short Form-Nepean Dyspepsia Index (SFNDI) is recorded at baseline, week 4 and week 8 during the double-blind treatment respectively. 10 Questions are asked about how the subject's stomach pain, discomfort, or other epigastric symptoms over the last 14 days have affected his/her life.
Time Frame
At baseline, week 4 and week 8
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 Rome IV diagnostic criteria for functional dyspepsia-postprandial distress syndrome;
At least 3 days during the one-week run-in period with VAS score ≥ 4 for major symptoms (at least one of postprandial fullness discomfort and early satiety) .
Be able to discontinue prohibited medications that may affect the evaluation of the effectiveness.
Written informed consent.
Exclusion Criteria:
Gastroscopic findings of gastric cancer, peptic ulcer, erosive gastritis (grade 2 or higher), moderate to severe atrophic gastritis, dysplasia, or other organ gastrointestinal disease.
History of abdominal surgery (except for appendectomy and cesarean section);
Immune system defects, or those who have been administered immunosuppressive agents or glucocorticoids within the past 3 months.
With combined severe cardiac and pulmonary insufficiency, insufficiency of liver (ALT/AST > 1.5 times the upper limit of the normal value), kidney insufficiency (BUN/SCr > the upper limit of the normal value), abnormal of endocrine system, abnormal hematopoietic system, and iron deficiency anemia as indicated on hematological examination.
With severe anxiety and depression.
With psychosis and mental retardation, language disorder precluding the ability of filling scales or recording symptoms.
Pregnancy or lactating; or patients of childbearing potential without effective contraception.
known to be allergic to the ingredients of this drug.
suspected or confirmed history of alcohol or drug abuse.
have participated in a clinical trial in the past 3 months.
deemed by the investigator as being not suitable for participation in the clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Zhong, MD., Ph.D
Phone
852-34116523
Email
ldzhong0305@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaoxiang Bian, MD., Ph.D
Organizational Affiliation
Hong Kong Chinese Medicine Clinical Study Centre
Official's Role
Study Director
Facility Information:
Facility Name
Linda Zhong
City
Kowloon Tong
State/Province
Kowloon
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Zhong, MD,PhD
Phone
34116523
Email
ldzhong0305@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Zhizhu Kuanzhong Capsule for Patients With Functional Dyspepsia-Postprandial Distress Syndrome
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