Ulcerative ColitisQHQYPNCT05780723
Treatment of Ulcerative Colitis With Rectal Instillation of Qinghua Quyu Prescription(QHQYP)
A study testing Treatment group: Rectal instillation of QHQYP in people with Ulcerative Colitis, run by Beijing Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
This study will enroll 60 patients with mild to moderate active ulcerative colitis as subjects. They will be randomly divided into two groups: the TCM group received QHQYP rectal instillation, while the control group received mesalazine enema. The treatment period for both groups was 8 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Treatment group: Rectal instillation of QHQYP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 4 Apr 2023to 23 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets the diagnostic criteria for active ulcerative colitis, with clinical severity being mild or moderate and the lesion range being limited to the rectum or left colon and not extending beyond the splenic flexure.
- Traditional Chinese medicine diagnosis indicates the presence of damp-heat syndrome in the large intestine.
- Between the ages of 18 and 65, regardless of gender.
- Informed consent and voluntary participation are required. The process of obtaining informed consent should comply with GCP regulations.
Who cannot join
- Patients with severe disease condition.
- Patients with infectious colonic diseases such as chronic schistosomiasis, bacterial dysentery, amoebic dysentery, intestinal tuberculosis, as well as non-infectious colonic diseases such as Crohn's disease, ischemic bowel disease, and radiation enteritis.
- Patients with serious complications such as local stenosis, intestinal obstruction, intestinal perforation, rectal polyps, toxic megacolon, colon cancer, rectal cancer, and anal diseases.
- Pregnant or lactating women.
- Patients with severe primary heart, liver, lung, kidney, blood or other severe diseases that affect their survival.
- Patients with disabilities as defined by law (blind, deaf, mute, intellectually disabled, mentally ill, physically disabled).
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- Patients with suspected or confirmed history of alcohol or drug abuse.
- Other conditions that may reduce the likelihood of enrollment or complicate enrollment, as determined by the researcher, such as frequent changes in work environment that may lead to loss of follow-up.
- Patients with allergies to two or more drugs or foods, or with a history of allergy to the components of this medication.
- Patients currently participating in other clinical trials of medications.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Dongcheng, Beijing Municipality, 100010
About this study
Official title: A Randomized Controlled Study of Qinghua Quyu Prescription Rectal Instillation for the Treatment of Ulcerative Colitis
This study will enroll 60 patients with mild to moderate active ulcerative colitis as subjects. They will be randomly divided into two groups: the TCM group received QHQYP rectal instillation, while the control group received mesalazine enema. The treatment period for both groups was 8 weeks. The modified Mayo Activity Index will be used as the main evaluation index. Secondary evaluation indices will include the Underwater Endoscopic Severity Index (UCEIS) score, endoscopic Baron score, mucosal histological score (Geboes index), Chinese medicine syndrome efficacy evaluation, quality of life score, physicochemical indicators reflecting disease activity or remission, intestinal microbiota indicators, and changes in inflammation and immune-related indicators in colonoscopy biopsy tissues. Safety indicators were also monitored.
- Conditions
- Ulcerative Colitis
- Being tested
- Treatment group: Rectal instillation of QHQYP, Control group: Mesalazine enema treatment
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment group: Rectal instillation of QHQYPDrug
Also called QHQYP is prepared by unified decocting from the Pharmacy Department of Beijing Hospital of Traditional Chinese Medicine, Capital Medical University.
QHQYP is decocted in water, with a dose of 100ml each time, and rectal drip before going to bed, once a night, for 8 weeks.
Control group: Mesalazine enema treatmentDrug
Also called Mesalazine enema is produced by Vifor AG Zweigniederlassung Medichemie Ettingen, National medicine approval H20150127.
Mesalazine enema, 4g/tube, 1 tube each time, enema before bed, once a night, a total of 8 weeks of continuous treatment.
| Study group | Role | What they receive |
|---|---|---|
| The TCM group is treated with QHQYP by rectal instillation. | Experimental | QHQYP is decocted in water, with a dose of 100ml each time, and rectal instillation before going to bed, once a night, for 8 weeks. Receives: Drug: Treatment group: Rectal instillation of QHQYP |
| The control group is treated with mesalazine enema. | Active comparator | Mesalazine enema, 4g/tube, 1 tube each time, enema before bed, once a night, for 8 weeks. Receives: Drug: Control group: Mesalazine enema treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Modified Mayo Activity Index at 8 weeks of treatment
To understand the remission status of ulcerative colitis from the stool frequency, rectal bleeding, colonic mucosa condition and physician's overall evaluation. Each of the above aspects includes four levels (from 0 to 3, with higher scores indicating more severe disease).
Measured: Evaluation will be made at baseline and 8 weeks of treatment.
Secondary outcomes (6)
Change from Ulcerative Colitis Endoscopic Index of Severity(UCEIS) at 8 weeks of treatment
It focuses on three aspects: vascular pattern, bleeding and erosions\&ulcers. The total score of the three scores can range from 0-8 (normal: 0, mild activity: 1-3, moderate activity: 4-6, and severe activity: 7-8.
Measured: Evaluation will be made at baseline and 8 weeks of treatment.
Change from Endoscopic Baron score at 8 weeks of treatment
To understand the degree of activity of endoscopic ulcerative colitis.It includes four levels (from 0 to 3, with higher scores indicating more severe disease).
Measured: Evaluation will be made at baseline and 8 weeks of treatment.
Change from Geboes Score at 8 weeks of treatment
To understand the status of mucosal tissue score. It ranges from Grade 0 (Architectural changes) , Grade 1 (chronic inflammatory cell infiltration), Grade 2 (neutrophils and eosinophils), Grade 3 (epithelial neutrophils) , Grade 4 (crypt destruction) to Grade 5 (erosion and ulcer). The higher the Geboes score, the more serious the disease activity. A grade lower than 2A.0 can be regarded as histological remission.
Measured: Evaluation will be made at baseline and 8 weeks of treatment.
Change from Evaluation of curative effect of traditional Chinese medicine syndrome at 8 weeks of treatment
Traditional Chinese medicine (TCM) syndrome score of ulcerative colitis will be carried out to understand whether the symptoms of patients improved after treatment. It consists of 9 questions, and the total scores are ranging from 0 to 43 with higher scores indicating more severe disease.
Measured: Evaluation will be made at baseline and 2,4,8 weeks of treatment.
Change from Quality of life score at 8 weeks of treatment
To understand the quality of life score of patients. It consists of 32 questions divided into four dimensions: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items) and social function (5 items). Every question has graded responses from 1 (worst situation) to 7 (best situation), and thus the total score is ranging from 32 to 224 with higher scores representing better quality of life.
Measured: Evaluation will be made at baseline and 8 weeks of treatment.
Change from Intestinal flora at 8 weeks of treatment
Fresh feces are collected at baseline and 8 weeks of treatment, and the distribution of intestinal flora is detected by 16s rRNA sequencing technology.
Measured: Examination will be performed at baseline and 8 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start4 Apr 2023
- Primary completion23 Oct 2024
- Study completion23 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luqing Zhao, Beijing Hospital of Traditional Chinese Medicine
- Investigators
- Luqing Zhao, Doctor, Principal investigator, Beijing Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780723
- Sponsor's protocol ID
- Z221100007422094
- Acronym
- QHQYP
- Status last verified
- Dec 2024
- First submitted
- 8 Mar 2023
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ng SC, Shi HY, Hamidi N, Underwood FE, Tang W, Benchimol EI, Panaccione R, Ghosh S, Wu JCY, Chan FKL, Sung JJY, Kaplan GG. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2017 Dec 23;390(10114):2769-2778. doi: 10.1016/S0140-6736(17)32448-0. Epub 2017 Oct 16.
PubMed 29050646Jones GR, Lyons M, Plevris N, Jenkinson PW, Bisset C, Burgess C, Din S, Fulforth J, Henderson P, Ho GT, Kirkwood K, Noble C, Shand AG, Wilson DC, Arnott ID, Lees CW. IBD prevalence in Lothian, Scotland, derived by capture-recapture methodology. Gut. 2019 Nov;68(11):1953-1960. doi: 10.1136/gutjnl-2019-318936. Epub 2019 Jul 11.
PubMed 31300515Ahmad R, Sorrell MF, Batra SK, Dhawan P, Singh AB. Gut permeability and mucosal inflammation: bad, good or context dependent. Mucosal Immunol. 2017 Mar;10(2):307-317. doi: 10.1038/mi.2016.128. Epub 2017 Jan 25.
PubMed 28120842Wu Y, Tang L, Wang B, Sun Q, Zhao P, Li W. The role of autophagy in maintaining intestinal mucosal barrier. J Cell Physiol. 2019 Nov;234(11):19406-19419. doi: 10.1002/jcp.28722. Epub 2019 Apr 24.
PubMed 31020664Li Q, Cui Y, Xu B, Wang Y, Lv F, Li Z, Li H, Chen X, Peng X, Chen Y, Wu E, Qu D, Jian Y, Si H. Main active components of Jiawei Gegen Qinlian decoction protects against ulcerative colitis under different dietary environments in a gut microbiota-dependent manner. Pharmacol Res. 2021 Aug;170:105694. doi: 10.1016/j.phrs.2021.105694. Epub 2021 Jun 2.
PubMed 34087350
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Qinghua Quyu Prescription Rectal Instillation for the Treatment of Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05780723
- Acronym / sponsor ID
- QHQYP / Z221100007422094
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beijing Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will enroll 60 patients with mild to moderate active ulcerative colitis as subjects. They will be randomly divided into two groups: the TCM group received QHQYP rectal instillation, while the control group received mesalazine enema. The treatment period for both groups was 8 weeks. The modified Mayo Activity Index will be used as the main evaluation index. Secondary evaluation indices will include the Underwater Endoscopic Severity Index (UCEIS) score, endoscopic Baron score, mucosal histological score (Geboes index), Chinese medicine syndrome efficacy evaluation, quality of life score, physicochemical indicators reflecting disease activity or remission, intestinal microbiota indicators, and changes in inflammation and immune-related indicators in colonoscopy biopsy tissues. Safety indicators were also monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The TCM group is treated with QHQYP by rectal instillation. | Experimental | Drug: Treatment group: Rectal instillation of QHQYPQHQYP is decocted in water, with a dose of 100ml each time, and rectal instillation before going to bed, once a night, for 8 weeks. |
| The control group is treated with mesalazine enema. | Active comparator | Drug: Control group: Mesalazine enema treatmentMesalazine enema, 4g/tube, 1 tube each time, enema before bed, once a night, for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets the diagnostic criteria for active ulcerative colitis, with clinical severity being mild or moderate and the lesion range being limited to the rectum or left colon and not extending beyond the splenic flexure.
- Traditional Chinese medicine diagnosis indicates the presence of damp-heat syndrome in the large intestine.
- Between the ages of 18 and 65, regardless of gender.
- Informed consent and voluntary participation are required. The process of obtaining informed consent should comply with GCP regulations.
Key exclusion criteria (10 listed)
- Patients with severe disease condition.
- Patients with infectious colonic diseases such as chronic schistosomiasis, bacterial dysentery, amoebic dysentery, intestinal tuberculosis, as well as non-infectious colonic diseases such as Crohn's disease, ischemic bowel disease, and radiation enteritis.
- Patients with serious complications such as local stenosis, intestinal obstruction, intestinal perforation, rectal polyps, toxic megacolon, colon cancer, rectal cancer, and anal diseases.
- Pregnant or lactating women.
- Patients with severe primary heart, liver, lung, kidney, blood or other severe diseases that affect their survival.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment group: Rectal instillation of QHQYPAlso: QHQYP is prepared by unified decocting from the Pharmacy Department of Beijing Hospital of Traditional Chinese Medicine, Capital Medical University.QHQYP is decocted in water, with a dose of 100ml each time, and rectal drip before going to bed, once a night, for 8 weeks. | Drug | The TCM group is treated with QHQYP by rectal instillation. |
| Control group: Mesalazine enema treatmentAlso: Mesalazine enema is produced by Vifor AG Zweigniederlassung Medichemie Ettingen, National medicine approval H20150127.Mesalazine enema, 4g/tube, 1 tube each time, enema before bed, once a night, a total of 8 weeks of continuous treatment. | Drug | The control group is treated with mesalazine enema. |
Primary outcome
Change from Modified Mayo Activity Index at 8 weeks of treatment
Time frame: Evaluation will be made at baseline and 8 weeks of treatment.
To understand the remission status of ulcerative colitis from the stool frequency, rectal bleeding, colonic mucosa condition and physician's overall evaluation. Each of the above aspects includes four levels (from 0 to 3, with higher scores indicating more severe disease).
6 secondary outcomes
Change from Ulcerative Colitis Endoscopic Index of Severity(UCEIS) at 8 weeks of treatment
Time frame: Evaluation will be made at baseline and 8 weeks of treatment.
Change from Endoscopic Baron score at 8 weeks of treatment
Time frame: Evaluation will be made at baseline and 8 weeks of treatment.
Change from Geboes Score at 8 weeks of treatment
Time frame: Evaluation will be made at baseline and 8 weeks of treatment.
Change from Evaluation of curative effect of traditional Chinese medicine syndrome at 8 weeks of treatment
Time frame: Evaluation will be made at baseline and 2,4,8 weeks of treatment.
Change from Quality of life score at 8 weeks of treatment
Time frame: Evaluation will be made at baseline and 8 weeks of treatment.
Change from Intestinal flora at 8 weeks of treatment
Time frame: Examination will be performed at baseline and 8 weeks of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Background: PubMed 29050646Ng SC, Shi HY, Hamidi N, Underwood FE, Tang W, Benchimol EI, Panaccione R, Ghosh S, Wu JCY, Chan FKL, Sung JJY, Kaplan GG. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2017 Dec 23;390(10114):2769-2778. doi: 10.1016/S0140-6736(17)32448-0. Epub 2017 Oct 16.
- Background: PubMed 31300515Jones GR, Lyons M, Plevris N, Jenkinson PW, Bisset C, Burgess C, Din S, Fulforth J, Henderson P, Ho GT, Kirkwood K, Noble C, Shand AG, Wilson DC, Arnott ID, Lees CW. IBD prevalence in Lothian, Scotland, derived by capture-recapture methodology. Gut. 2019 Nov;68(11):1953-1960. doi: 10.1136/gutjnl-2019-318936. Epub 2019 Jul 11.
- Background: PubMed 28120842Ahmad R, Sorrell MF, Batra SK, Dhawan P, Singh AB. Gut permeability and mucosal inflammation: bad, good or context dependent. Mucosal Immunol. 2017 Mar;10(2):307-317. doi: 10.1038/mi.2016.128. Epub 2017 Jan 25.
- Background: PubMed 31020664Wu Y, Tang L, Wang B, Sun Q, Zhao P, Li W. The role of autophagy in maintaining intestinal mucosal barrier. J Cell Physiol. 2019 Nov;234(11):19406-19419. doi: 10.1002/jcp.28722. Epub 2019 Apr 24.
- Background: PubMed 34087350Li Q, Cui Y, Xu B, Wang Y, Lv F, Li Z, Li H, Chen X, Peng X, Chen Y, Wu E, Qu D, Jian Y, Si H. Main active components of Jiawei Gegen Qinlian decoction protects against ulcerative colitis under different dietary environments in a gut microbiota-dependent manner. Pharmacol Res. 2021 Aug;170:105694. doi: 10.1016/j.phrs.2021.105694. Epub 2021 Jun 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luqing Zhao, Doctor principal investigator
Beijing Hospital of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment group: Rectal instillation of QHQYP in people with Ulcerative Colitis, run by Beijing Hospital of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Modified Mayo Activity Index at 8 weeks of treatment (time frame: Evaluation will be made at baseline and 8 weeks of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05780723, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.