International Clinical Study of Zhizhu Kuanzhong Capsule

NCT ID: NCT03825692

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-24
• Study Completion Date: 2023-12-31

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.

Conditions

Functional Dyspepsia; Postprandial Distress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Zhizhu Kuanzhong Capsule

Intervention Type: DRUG

Zhizhu Kuanzhong Capsule, 3 capsules at a time, 3 times a day, taken orally 10-15 min before meals. an 8-week intervention period

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.

Group Type: PLACEBO_COMPARATOR

Zhizhu Kuanzhong Placebo Capsule

Intervention Type: DRUG

Placebo, 3 capsules at a time, 3 times a day, taken orally 10-15 min before meals. an 8-week intervention period

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

ZZKZ capsule; placebo

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fang Lu, Md, Phd

Role: STUDY_DIRECTOR

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Locations

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Site Status: NOT_YET_RECRUITING

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Peking Union Medical College Hospital of Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Fujian Provincial Hospital

Fuzhou, Fujian, China

Site Status: RECRUITING

Peking Union Medical College Hospital of Chinese Academy of Medical Sciences

Guangzhou, Guangdong, China

Site Status: RECRUITING

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

Site Status: RECRUITING

Hong Kong Baptist University

Hong Kong, Hongokng, China

Site Status: RECRUITING

Wuhan Union Hospital

Wuhan, Hubei, China

Site Status: RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Shengjing Hospital Affiliated to China Medical University

Shenyang, Liaoning, China

Site Status: RECRUITING

Kulun Qimeng Hospital

Tongliao, Neimenggu, China

Site Status: COMPLETED

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Affiliated Hospital of Shaanxi University of traditional Chinese medicine

Xi’an, Shanxi, China

Site Status: RECRUITING

Shaanxi Academy of Traditional Chinese Medicine

Xi’an, Shanxi, China

Site Status: RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Site Status: RECRUITING

Countries

Australia; China

Central Contacts

Fang Lu, MD,Phd

Role: CONTACT

deerfang@126.com

+861062835652

Yingpan Zhao, MD,Phd

Role: CONTACT

zypzyp1984@163.com

86015810964983

Facility Contacts

Gerald Holtmann

Role: primary

Fang Lu, Phd

Role: primary

deerfang@163.com

+861062835652

Yu Lan

Role: primary

Xiaohong Sun

Role: primary

Lin

Role: primary

Yinglian Xiao

Role: primary

Fengbin Liu

Role: primary

Linda Zhong

Role: primary

Xiaohua Hou

Role: primary

Guoxin Zhang

Role: primary

Yan Li

Role: primary

Duowu Zou

Role: primary

Jiehong Wang

Role: primary

Tao Yu

Role: primary

Jinghai Wang

Role: primary

References

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.

Reference Type: DERIVED

PMID: 35655286 (View on PubMed)

Other Identifiers

2017YFC1703703

Identifier Type: -

Identifier Source: org_study_id