Compare the combination of traditional Chinese medicine (Qingre Huashi Quyu) and mesalazine with mesalazine for the treatment of ulcerative colitis.
| ISRCTN | ISRCTN79390119 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79390119 |
| Secondary identifying numbers | 2019-02-25 |
- Submission date
- 25/04/2019
- Registration date
- 07/05/2019
- Last edited
- 29/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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 2022
Who is funding the study?
Beijing municipal commission of science and technology
Who is the main contact?
Dr Luqing Zhao
zhaoluqing111@163.com
Contact information
Scientific
No. 23
Art Museum Houjie Street
Dongcheng District
Beijing
100010
China
 ORCID ID |
0000-0003-1986-3511 |
|---|---|
| Phone | +8601052176634 |
| zhaoluqing111@163.com |
Study information
| Study design | Interventional single-center randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Efficacy of Qingrehuashiquyu recipe on ulcerative colitis: a randomized controlled study |
| Study objectives | Combination of Qingrehuashiquyu recipe and mesalazine is more effective in the treatment of ulcerative colitis than mesalazine used alone. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Qingrehuashi quyu recipe |
| Primary outcome measure | Current primary outcome measure as of 29/10/2021: Mayo Activity Index, assessed at baseline and 12 weeks Previous primary outcome measure: Mucosal histology score measured using Geboes index, assessed at baseline and 12 weeks. |
| Secondary outcome measures | Current secondary outcome measures as of 29/10/2021: 1. Mucosal histology score measured using Geboes 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 Previous 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 study start date | 01/06/2018 |
| Completion date | 01/08/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 20/04/2019 |
| Date of final enrolment | 01/05/2021 |
Locations
Countries of recruitment
- China
Study participating centre
Capital Medical University
No. 23
Art Museum Houjie Street
Dongcheng District
Beijing
100010
China
Sponsor information
Government
Building 1
No. 57
Canal East Street
Tongzhou District
Beijing
100744
China
| Phone | 010-55577777 |
|---|---|
| kangxiuhong@163.com | |
| Website | http://kw.beijing.gov.cn/ |
"ROR" |
https://ror.org/034k14f91 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Science and Technology Commission of Beijing Municipality, Beijing Municipal Science & Technology Commission, Adminitrative Commission of Zhongguancun Science Park, Beijing Municipal Science and Technology Commission, Beijing Municipal Science & Technology Commission, 北京市科学技术委员会, 北京市科学技术委员会, 中关村科技园区管委会
- Location
- China
Results and Publications
| Intention to publish date | 01/08/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Editorial Notes
29/10/2021: The following changes have been made:
1. The overall trial end date has been changed from 01/08/2021 to 01/08/2022 and the plain English summary has been updated to reflect this change.
2. The primary outcome measure has been updated.
3. The secondary outcome measures have been updated.
07/05/2019: Trial’s existence confirmed by Ethics Committee of Beijing Chinese Medicine Hospital affiliated to Capital Medical University.
