Condition category
Digestive System
Date applied
25/04/2019
Date assigned
07/05/2019
Last edited
07/05/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Ulcerative colitis (UC) is a non-specific inflammation of the intestine, with abdominal pain, diarrhea, mucus pus and bloody stools and urgency as the main clinical manifestations. Because the cause is unknown, difficult to cure, easy to progress to a cancer, it has been listed as a difficult disease by the World Health Organization (WHO). This study aims to determine whether the Qingrehuashiquyu recipe might help those UC patients, as previous studies have shown it may be beneficial.

Who can participate?
Adults aged 18-65 who have been diagnosed by their doctors as having ulcerative colitis.

What does the study involve?
Participants are randomly allocated to one of two groups:
1. Qingrehuashiquyu recipe 200ml, taken orally two times per day and mesalazine 0.25g, taken orally four times per day for 12 weeks
2. Mesalazine 0.25g,taken orally four times per day for 12 weeks
Following completion of this 8 week period, there is another 12 week follow-up period.

What are the possible benefits and risks of participating?
The possible benefit of participating is that the Qingrehuashiquyu recipe and mesalazine may improve symptoms of patients, although this cannot be guaranteed. The possible risks of participating are that the treatment may cause side effects including epigastric discomfort, nausea, headache and dizziness, although this is unlikely.

Where is the study run from?
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, China

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

Who is funding the study?
Beijing municipal commission of science and technology

Who is the main contact?
Dr Luqing Zhao
zhaoluqing111@163.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Luqing Zhao

ORCID ID

http://orcid.org/0000-0003-1986-3511

Contact details

No. 23
Art Museum Houjie Street
Dongcheng District
Beijing
100010
China
+8601052176634
zhaoluqing111@163.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

2019-02-25

Study information

Scientific title

Efficacy of Qingrehuashiquyu recipe on ulcerative colitis: a randomized controlled study

Acronym

Study hypothesis

Combination of Qingrehuashiquyu recipe and mesalazine is more effective in the treatment of ulcerative colitis than mesalazine used alone.

Ethics approval

Approved 25/02/2019, Ethics Committee of Beijing Chinese Medicine Hospital affiliated to Capital Medical University (Beijing Hospital of Traditional Chinese Medicine Capital Medical University No. 23 Art Museum Houjie Street Dongcheng District; ecbjtcm@126.com; +8601052171516), ref: 2019BL02-007-01

Study design

Interventional single-center randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Ulcerative colitis

Intervention

Participants are randomly allocated to one of two groups using SAS9.10 software:
1. Qingrehuashiquyu recipe 200ml, taken orally two times per day and mesalazine 0.25g,taken orally four times per day for 12 weeks
2. Mesalazine 0.25g,taken orally four times per day for 12 weeks
Following completion of this 12 week period, there is another 12 week follow-up period.

Clinical symptoms data and samples including blood, stool and colonic mucosa will be collected by clinicians. Blood will be collected by drawing blood of centrifugal vein. Stool will be collected by specimen box. Colonic mucosa will be collected by electronic endoscope.

Intervention type

Drug

Phase

Not Specified

Drug names

Qingrehuashi quyu recipe

Primary outcome measure

Mucosal histology score measured using Geboes index, assessed at baseline and 12 weeks.

Secondary outcome measures

1. Mayo Activity Index, assessed at baseline and 12 weeks
2. Traditional Chinese Medicine syndromes of UC score, assessed at baseline,4,8 and 12weeks
3. Fecal occult blood test, erythrocyte sedimentation rate, C-reactive protein, fecal calprotectin at baseline and 12weeks
4. Detection of intestinal apoptosis at baseline and 12 weeks
5. Detection of intestinal flora at baseline and 12 weeks
6. Detection of intestinal nitric oxide at baseline and 12 weeks
7. Inflammatory bowel disease quality of life scale at baseline and 12 weeks

Overall trial start date

01/06/2018

Overall trial end date

01/08/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. The diagnosis of ulcerative colitis is active, and the clinical severity is mild to moderate.
2. Meeting the Traditional Chinese Medicine syndrome of large intestinal damp-heat criteria.
3. The age is between 18 and 65 years old, and gender is not limited.
4. The patient signs informed consent. The process of obtaining informed consent should be in accordance with GCP regulations.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. The type of ulcerative colitis is acute fulminant, and the severity of the condition is severe.
2. Infectious colitis such as bacillary dysentery, amoebic sputum, chronic schistosomiasis, intestinal tuberculosis, and patients with Crohn's colitis, ischemic enteritis, and radiation enteritis.
3. Patients with serious complications such as local stenosis, intestinal obstruction, intestinal perforation, rectal polyps, toxic colonic dilatation, colon cancer, rectal cancer and anal disease.
4. Pregnant and lactating women
5. Those with severe primary heart, liver, lung, kidney, blood or serious diseases that affect their survival.
6. Disabled patients prescribed by law.
7. Suspected or indeed had a history of alcohol and drug abuse.
8. Poor compliance or any other reason the researchers believe may not be appropriate to participate in this trial.
9. Allergic constitution or known to be allergic to the drug used in this trial.
10. Patients who are participating in other drug clinical trials.

Recruitment start date

20/04/2019

Recruitment end date

01/05/2021

Locations

Countries of recruitment

China

Trial participating centre

Digestive Disease Center
Beijing Hospital of Traditional Chinese Medicine Capital Medical University No. 23 Art Museum Houjie Street Dongcheng District
Beijing
100010
China

Sponsor information

Organisation

Beijing Municipal Science & Technology Commission

Sponsor details

Building 1
No. 57
Canal East Street
Tongzhou District
Beijing
100744
China
010-55577777
kangxiuhong@163.com

Sponsor type

Government

Website

http://kw.beijing.gov.cn/

Funders

Funder type

Government

Funder name

Beijing Municipal Science and Technology Commission

Alternative name(s)

Science and Technology Commission of Beijing Municipality

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

China

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

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

Intention to publish date

01/08/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/05/2019: Trial’s existence confirmed by Ethics Committee of Beijing Chinese Medicine Hospital affiliated to Capital Medical University.