Clinical trial NCT03825692: International Clinical Study of Zhizhu Kuanzhong Capsule
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Functional Dyspepsia
Postprandial Distress Syndrome
Keywords: Functional Dyspepsia
Postprandial Distress Syndrome
Traditional Chinese Medicine
efficacy
safety
clinical evaluation
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2019-01-31
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled, multi-center
Primary purpose: TREATMENT

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.

Detailed description: Functional dyspepsia (FD) is one of the most common functional gastrointestinal disorders. Current data from clinical studies have shown that traditional Chinese medicine can obviously relieve clinical symptoms of patients with FD, and has special advantages and good clinical application prospects in the treatment of FD. Zhizhu Kuanzhong Capsule is mainly composed of the following 4 kinds of Chinese herbs: Rhizoma Atractylodis Macrocephala, Fructus Aurantii Immaturus, Radix Bupleuri and Fructus Crataegi. 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). This is a multi-center, stratified-block randomized, double-blind and placebo parallel-controlled trial. The comparison between the investigational drug and the placebo will be conducted with superiority design. About 480 subjects matched Rome IV diagnostic criteria for FD PDS will be enrolled. For each subject, this study includes a 0-2 week screening period, a 1-week run-in period, an 8-week double-blind treatment period, and a 4-week follow-up period. The drugs used in the clinical study (including investigational drug and placebo) will be supplied by Shuangren Pharmaceutical Co., Ltd. of Lonch Group.The quality standards and test methods for the placebo are consistent with those for the investigational drug, and the quality test meets the proposed quality standards. The selection and evaluation bias are controlled by means of strictly implementing randomized control blinded method etc, and the investigator will be trained on the consistency of scale evaluation.The electronic case report form (hereinafter referred to as eCRF) of this trial is created using the Medical Clinical Trial Data Management System (eCDMS3.0) for online data acquisition and management via the Internet. The data in the eCRF are from the original documents such as the original medical records and the physicochemical examination report sheets and should be consistent with the original documents. The response rate for functional dyspepsia VAS score will be compared between the test group and control group at 8 weeks after randomization.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: The proportion of the response at 8 weeks after randomization
timeFrame: up to 8 weeks
Secondary outcomes:
measure: The change of VAS score of each symptom of functional dyspepsia
timeFrame: Up to 8 weeks
measure: Overall treatment response rate
timeFrame: Up to 8 weeks
measure: Short Form Nepean Dyspepsia Index (SFNDI)
timeFrame: Up to 8 weeks
measure: Hospital Anxiety and Depression Scale score
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Beijing
country: China
facility: Xiyuan Hospital of China Academy of Chinese Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
state: Beijing
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
city: Guangzhou
country: China
facility: Peking Union Medical College Hospital of Chinese Academy of Medical Sciences
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
city: Hong Kong
country: China
facility: Hong Kong Baptist University
state: Hongokng
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Shenyang
country: China
facility: Shengjing Hospital Affiliated to China Medical University
state: Liaoning
city: Tongliao
country: China
facility: Kulun Qimeng Hospital
state: Neimenggu
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
city: Xi'an
country: China
facility: Affiliated Hospital of Shaanxi University of traditional Chinese medicine
state: Shanxi
city: Xi'an
country: China
facility: Shaanxi Academy of Traditional Chinese Medicine
state: Shanxi
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
Study officials:
affiliation: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: Fang Lu, Md, Phd
role: STUDY_DIRECTOR
References:
citation: 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.