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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03825692




Registration number
NCT03825692
Ethics application status
Date submitted
28/01/2019
Date registered
31/01/2019
Date last updated
4/08/2023

Titles & IDs
Public title
International Clinical Study of Zhizhu Kuanzhong Capsule
Scientific 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
Secondary ID [1] 0 0
2017YFC1703703
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional Dyspepsia 0 0
Postprandial Distress Syndrome 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Zhizhu Kuanzhong Capsule
Treatment: Drugs - Zhizhu Kuanzhong Placebo Capsule

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

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.


Treatment: Drugs: 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

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The proportion of the response at 8 weeks after randomization
Timepoint [1] 0 0
up to 8 weeks
Secondary outcome [1] 0 0
The change of VAS score of each symptom of functional dyspepsia
Timepoint [1] 0 0
Up to 8 weeks
Secondary outcome [2] 0 0
Overall treatment response rate
Timepoint [2] 0 0
Up to 8 weeks
Secondary outcome [3] 0 0
Short Form Nepean Dyspepsia Index (SFNDI)
Timepoint [3] 0 0
Up to 8 weeks
Secondary outcome [4] 0 0
Hospital Anxiety and Depression Scale score
Timepoint [4] 0 0
Up to 8 weeks

Eligibility
Key inclusion criteria
1. Meeting the Rome IV diagnostic criteria for functional dyspepsia-postprandial distress syndrome;
2. * 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) .
3. Age between 18 and 65 years old (including 18 and 65 years old), male or female, outpatients;
4. **Be able to discontinue prohibited medications that may affect the evaluation of the effectiveness, such as acid inhibition/antacids, prokinetic agents, non-steroidal anti-inflammatory drugs, anticholinergic agents, glucocorticoids, and therapeutic medication for H. pylori eradication.
5. Each subject is informed and voluntarily signed the informed consent form(ICF).

* Subjects who entered the one-week run-in period 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 rating was made once a day and 7 days a week with scores of 0 to 10.

* A 2-week wash-out period is required for patients taking prohibited medications prior to screening.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Gastroscopic findings of gastric cancer, peptic ulcer, erosive gastritis (grade 2 or higher), moderate to severe atrophic gastritis, dysplasia, or other organ gastrointestinal disease.
2. Patients with a history of abdominal surgery (except for appendectomy and cesarean section).
3. Patients with immune system defects (such as leukaemia or cancer), or those who have been administered immunosuppressive agents or glucocorticoids within the past 3 months.
4. Patients who combined severe cardiac and pulmonary insufficiency, insufficiency of liver (ALT/AST > 1.5 times the upper limit of the normal value) and kidney insufficiency (BUN/Serum Creatinine > the upper limit of the normal value), abnormal of endocrine system( such as diabetes and thyroid dysfunction), abnormal hematopoietic system, and iron deficiency anemia as indicated on hematological examination.
5. Patients with severe anxiety and depression.
6. Patients with psychosis and mental retardation as well as language disorder precluding the ability of filling scales or recording symptoms.
7. Pregnant (a female of childbearing potential with a positive pregnancy test) or lactating females; or patients of childbearing potential without effective contraception.
8. Patients who are known to be allergic to the ingredients of this drug.
9. Patients who are suspected to have or indeed have a history of alcohol or drug abuse.
10. Patients who have participated in a clinical trial in the past 3 months.
11. Patients who are deemed by the investigator as being not suitable for participation in the clinical trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
480
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Fujian
Country [3] 0 0
China
State/province [3] 0 0
Guangdong
Country [4] 0 0
China
State/province [4] 0 0
Hongokng
Country [5] 0 0
China
State/province [5] 0 0
Hubei
Country [6] 0 0
China
State/province [6] 0 0
Jiangsu
Country [7] 0 0
China
State/province [7] 0 0
Liaoning
Country [8] 0 0
China
State/province [8] 0 0
Neimenggu
Country [9] 0 0
China
State/province [9] 0 0
Shanghai
Country [10] 0 0
China
State/province [10] 0 0
Shanxi

Funding & Sponsors
Primary sponsor type
Other
Name
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This trial aims to evaluate the clinical efficacy and safety of Zhizhu Kuanzhong Capsule in the treating patients with functional dyspepsia postprandial distress syndrome(FD PDS). Half of participants will receive Zhizhu Kuanzhong Capsule,while the other will receive a placebo.
Trial website
https://clinicaltrials.gov/study/NCT03825692
Trial related presentations / publications
Xiao M, Zhong LLD, Lam WC, Zhao Y, Gwee KA, Holtmann G, Tack J, Suzuki H, Chen MH, Xiao Y, Hou X, Liu J, Li Y, Tang XD, Lu F. Zhizhu Kuanzhong Capsule in treating patients with functional dyspepsia postprandial distress syndrome: study protocol for a multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. Trials. 2022 Jun 2;23(1):454. doi: 10.1186/s13063-022-06396-5.
Public notes

Contacts
Principal investigator
Name 0 0
Fang Lu, Md, Phd
Address 0 0
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Fang Lu, MD,Phd
Address 0 0
Country 0 0
Phone 0 0
+861062835652
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03825692