NCT03825692

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 Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2019

Longer than P75 for phase_4

Geographic Reach
2 countries

16 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

October 24, 2019

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 4, 2023

Status Verified

January 1, 2023

Enrollment Period

4.1 years

First QC Date

January 28, 2019

Last Update Submit

August 2, 2023

Conditions

Functional DyspepsiaPostprandial Distress Syndrome

Keywords

Functional DyspepsiaPostprandial Distress SyndromeTraditional Chinese Medicineefficacysafetyclinical evaluation

Outcome Measures

Primary Outcomes (1)

  • The proportion of the response at 8 weeks after randomization

    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.

    up to 8 weeks

Secondary Outcomes (4)

  • The change of VAS score of each symptom of functional dyspepsia

    Up to 8 weeks

  • Overall treatment response rate

    Up to 8 weeks

  • Short Form Nepean Dyspepsia Index (SFNDI)

    Up to 8 weeks

  • Hospital Anxiety and Depression Scale score

    Up to 8 weeks

Study Arms (2)

Zhizhu Kuanzhong Capsule

EXPERIMENTAL

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 Placebo Capsule

PLACEBO COMPARATOR

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

Interventions

Zhizhu Kuanzhong CapsuleDRUG

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

Also known as: ZZKZ capsule
Zhizhu Kuanzhong Capsule
Zhizhu Kuanzhong Placebo CapsuleDRUG

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

Also known as: placebo
Zhizhu Kuanzhong Placebo Capsule

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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) .
  • Age between 18 and 65 years old (including 18 and 65 years old), male or female, outpatients;
  • \*\*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.
  • 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.

You may not qualify if:

  • Gastroscopic findings of gastric cancer, peptic ulcer, erosive gastritis (grade 2 or higher), moderate to severe atrophic gastritis, dysplasia, or other organ gastrointestinal disease.
  • Patients with a history of abdominal surgery (except for appendectomy and cesarean section).
  • 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.
  • 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.
  • Patients with severe anxiety and depression.
  • Patients with psychosis and mental retardation as well as language disorder precluding the ability of filling scales or recording symptoms.
  • Pregnant (a female of childbearing potential with a positive pregnancy test) or lactating females; or patients of childbearing potential without effective contraception.
  • Patients who are known to be allergic to the ingredients of this drug.
  • Patients who are suspected to have or indeed have a history of alcohol or drug abuse.
  • Patients who have participated in a clinical trial in the past 3 months.
  • Patients who are deemed by the investigator as being not suitable for participation in the clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Princess Alexandra Hospital

Brisbane, Queensland, Australia

NOT YET RECRUITING

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100091, China

RECRUITING

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, China

RECRUITING

Peking Union Medical College Hospital of Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

Fujian Provincial Hospital

Fuzhou, Fujian, China

RECRUITING

Peking Union Medical College Hospital of Chinese Academy of Medical Sciences

Guangzhou, Guangdong, China

RECRUITING

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

RECRUITING

Hong Kong Baptist University

Hong Kong, Hongokng, China

RECRUITING

Wuhan Union Hospital

Wuhan, Hubei, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, China

RECRUITING

Shengjing Hospital Affiliated to China Medical University

Shenyang, Liaoning, China

RECRUITING

Kulun Qimeng Hospital

Tongliao, Neimenggu, China

COMPLETED

Ruijin Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Affiliated Hospital of Shaanxi University of traditional Chinese medicine

Xi’an, Shanxi, China

RECRUITING

Shaanxi Academy of Traditional Chinese Medicine

Xi’an, Shanxi, China

RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35655286DERIVED

Study Officials

  • Fang Lu, Md, Phd

    Xiyuan Hospital of China Academy of Chinese Medical Sciences

    STUDY DIRECTOR

Central Study Contacts

Fang Lu, MD,Phd

CONTACT

+861062835652deerfang@126.com

Yingpan Zhao, MD,Phd

CONTACT

86015810964983zypzyp1984@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, double-blind, placebo-controlled, multi-center
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2019

First Posted

January 31, 2019

Study Start

October 24, 2019

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

August 4, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)CN(15)