Condition category
Infections and Infestations
Date applied
22/04/2018
Date assigned
09/05/2018
Last edited
14/05/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Helicobacter pylori infects approximately 50% of the adult population and is associated with a wide range of diseases. Because of antibiotic resistance, failure to eradicate (remove) Helicobacter pylori is becoming a common and challenging problem.
This study aims to see whether Jinghuaweikang capsule combined quadruple therapy might help those with refractory Helicobacter pylori infection. Previous studies have suggested a benefit but this needs confirmation.

Who can participate?
Adults aged 18 – 65 years with refractory Helicobacter pylori infection.

What does the study involve?
Participants are randomly allocated to one of three groups, to take a different combination of medication, as follows:
1. Rabeprazole 20 mg Bid and Bismuth potassium citrate 220mg Bid and amoxicillin 1 g Bid and furazolidone 0.1g Bid for 14 days
2. Rabeprazole 20 mg Bid and Bismuth potassium citrate 220mg Bid and amoxicillin 1 g Bid and furazolidone 0.1g Bid for 10 days and Jinghuaweikang capsule 160mg Tid for 14 days
3.Rabeprazole 20 mg Bid and Jinghuaweikang capsule 160mg Tid and amoxicillin 1 g Bid and furazolidone 0.1g Bid for 10 days and Jinghuaweikang capsule 160mg Tid for 14 days

Participants are followed up 56 days after starting their medication.

What are the possible benefits and risks of participating?
It is hoped that the Helicobacter pylori infection will be eradicated. The drugs have been used for many years and the side effects are well recognised. Only very few participants may not tolerate the drug because of stomach discomfort, dryness of the mouth, constipation, diarrhoea, nausea, rash or dizziness.

Where is the study run from?
1. Peking University First Hospital (China)
2. Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University (China)
3. PLA Army General Hospital (China)
4. Dongfang Hospital Beijing University of Chinese Medicine (China)
5. Guanganmen Hospital China Academy of Chinese Medical Sciences (China)
6. Aerospace Center Hospital (China)
7. Xijing Hospital of the Fourth Military Medical University (China)
8. China-Japan Union Hospital of Jinlin University (China)
9. Shengjing Hospital of China Medical University (China)
10. Nanfang Hospital of Southern Medical University (China)
11. Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology (China)
12. The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital (China)
13. The Second Affiliated Hospital of Xian Jiaotong University (China)
14. Qilu Hospital of Shandong University (China)
15. The Fifth Affiliated Hospital of Zhengzhou University (China)
16. Changhai Hospital, Second Military Medical University (China)

When is the study starting and how long is it expected to run for?
March 2018 to December 2021

Who is funding the study?
Tasly Pharmaceutical Group CO.,LTD (China)

Who is the main contact?
1. Dr. Fulian Hu (Public)
djjyhu@163.com
2. Dr.Shengsheng Zhang (Public)
zhss2000@163.com

Trial website

Contact information

Type

Public

Primary contact

Dr Fulian Hu

ORCID ID

Contact details

Peking University First Hospital
No.8 xishu street
Xicheng district
Beijing
100034
China

Type

Public

Additional contact

Dr Shengsheng Zhang

ORCID ID

Contact details

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
No.23 Meishuguanhou Street
Dongcheng District
Beijing
100010
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2018-03-20

Study information

Scientific title

Randomised multicentric controlled clinical trial to compare efficacy of Jinghuaweikang capsule combined quadruple therapy versus quadruple therapy on the refractory infection of Helicobacter pylori

Acronym

Study hypothesis

Jinghuaweikang capsule combined quadruple therapy is better than quadruple therapy

Ethics approval

Ethics Committee of Peking University First Hospital, 28/03/2018, ref: 2018-34

Study design

Multi-centre randomised parallel controlled trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Helicobacter pylori

Intervention

Participants are randomly allocated to one of three options of therapy:
1. Rabeprazole 20 mg Bid and Bismuth potassium citrate 220mg Bid and amoxicillin 1g Bid and furazolidone 0.1g Bid for 14 days
2. Rabeprazole 20 mg Bid and Bismuth potassium citrate 220mg Bid and amoxicillin 1g Bid and furazolidone 0.1g Bid for 10 days and Jinghuaweikang capsule 160mg Tid for 14 days
3.Rabeprazole 20 mg Bid and Jinghuaweikang capsule 160mg Tid and amoxicillin 1g Bid and furazolidone 0.1g Bid for 10 days and Jinghuaweikang capsule 160mg Tid for 14 days

The duration of follow up was 56 days after medications started.

Intervention type

Drug

Phase

Not Specified

Drug names

Primary outcome measure

Elimination rate of Helicobacter pylori is measured using 13C-urea breath test at 56 days

Secondary outcome measures

Gastrointestinal symptoms are measured using Scale of gastrointestinal symptoms at baseline, 14 days, 28 days and 56 days

Overall trial start date

01/03/2018

Overall trial end date

31/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 to 65 without gender limitation.
2. Meet the refractory Helicobacter pylori infection:
2.1. Referred after three or more than three standard therapy (according to consensus for 10-14 days, at least two times of standard quadruple therapy, at least one time for 14 days) failures in three years.
2.2. Received upper endoscopy and suitable for eradication of Helicobacter pylori.
3. Diagnosed with Helicobacter pylori infection by rapid urease test or 13C-urea breath test results.
4. Proven endoscopic gastritis (including atrophic gastritis and non-atrophic gastritis) or ulcers.
5. Participants without prior penicillin treatment need to demonstrate negative reaction to penicillin skin test.
6. No dyspepsia syndromes of epigastric discomfort, epigastric pain, acid regurgitation, heartburn, and so on, but meet indication of Helicobacter pylori eradication.
7. Accept the medications treatment voluntarily and signed informed consent.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

510

Participant exclusion criteria

1. History of stomach operation: partial gastrectomy, stomach plasty, vagotomy (but patients who had simple repair of gastroduodenal ulcer perforation or hemostatic suture of gastroduodenal ulcer were accepted)
2. Pregnancy or lactation, or childbearing age women without reliable contraception (e.g.,oophorectomy, hysterectomy, at least 6 months of tubal ligation, oral contraceptives, barrier method of contraception)
3. Cannot avoid alcohol during the experiment
4 Patients who concomitant with liver disease, kidney disease, cardiovascular disease, brain disease, pulmonary disease, endocrine system diseases, hematopoietic system disease, and other serious primary diseases which is not effectively controlled
5. Severe hepatic and renal insufficiency( transaminase is more than 1.5 times of the normal limit, or serum creatinine more than the upper limit of normal )or liver disease, anemia (hemoglobin < 90 g/L)
6. Allergic to furazolidone, penicillin, rabeprazole or ingredients of JinghuaWeikang Capsule
7. Used antibiotics, bismuth agent (>three timesper week) or clinical trial other drugs within 30 days
8 . Taking anticoagulant therapy or non-steroidal anti-inflammatory drugs (NSAIDs)
9. Swallowing difficulties
10. Used anti-ulcer drugs, including H2-receptor blocking agent, sucralfate, misoprostol or proton pump inhibitor (PPI) within two weeks
11. Zollinger-Ellison syndrome
12. Malignant tumor
13. Included in another clinical trial within 3 months
14. Inappropriate according to the investigator

Recruitment start date

01/08/2018

Recruitment end date

31/07/2021

Locations

Countries of recruitment

China

Trial participating centre

Peking University First Hospital
100034
China

Trial participating centre

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
100010
China

Trial participating centre

PLA Army General Hospital
100700
China

Trial participating centre

Dongfang Hospital, Beijing University of Chinese Medicine
100078
China

Trial participating centre

Guanganmen Hospital, China Academy of Chinese Medical Sciences
100053
China

Trial participating centre

Aerospace Center Hospital, Peking university
100049

Trial participating centre

Xijing Hospital of the Fourth Military Medical University
710032

Trial participating centre

China-Japan Union Hospital of Jinlin University
130033

Trial participating centre

Shengjing Hospital of China Medical University
110004

Trial participating centre

Nanfang Hospital of Southern Medical University
510515

Trial participating centre

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
430030

Trial participating centre

The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
210029

Trial participating centre

The Second Affiliated Hospital of Xian Jiaotong University
710004

Trial participating centre

Qilu Hospital of Shandong University
250012

Trial participating centre

The Fifth Affiliated Hospital of Zhengzhou University
450052

Trial participating centre

Changhai Hospital, Second Military Medical University
200433

Trial participating centre

Tianjin Medical University General Hospital
Tianjin
300052
China

Sponsor information

Organisation

China Health Promotion Foundation

Sponsor details

No.316 Wanfeng Road
FengTai District
Beijing
100161
China

Sponsor type

Charity

Website

Funders

Funder type

Industry

Funder name

Tasly Pharmaceutical Group CO.,LTD (China).

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high impact peer reviewed journal.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

14/05/2018: Tianjin Medical University General Hospital was added as a trial participating centre.