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
Funders
Funder type
Government
Funder name
Beijing Municipal Science and Technology Commission
Alternative name(s)
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