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Treatment of Ulcerative Colitis With Rectal Instillation of Qinghua Quyu Prescription(QHQYP) (QHQYP)

Primary Purpose

Ulcerative Colitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Treatment group: Rectal instillation of QHQYP
Control group: Mesalazine enema treatment
Sponsored by
Beijing Hospital of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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). 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.

Sites / Locations

  • Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

The TCM group is treated with QHQYP by rectal instillation.

The control group is treated with mesalazine enema.

Arm Description

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.

Mesalazine enema, 4g/tube, 1 tube each time, enema before bed, once a night, for 8 weeks.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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).
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.
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.
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.
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.

Full Information

First Posted
March 8, 2023
Last Updated
March 21, 2023
Sponsor
Beijing Hospital of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05780723
Brief Title
Treatment of Ulcerative Colitis With Rectal Instillation of Qinghua Quyu Prescription(QHQYP)
Acronym
QHQYP
Official Title
A Randomized Controlled Study of Qinghua Quyu Prescription Rectal Instillation for the Treatment of Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Hospital of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The TCM group is treated with QHQYP by rectal instillation.
Arm Type
Experimental
Arm Description
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.
Arm Title
The control group is treated with mesalazine enema.
Arm Type
Active Comparator
Arm Description
Mesalazine enema, 4g/tube, 1 tube each time, enema before bed, once a night, for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Treatment group: Rectal instillation of QHQYP
Other Intervention Name(s)
QHQYP is prepared by unified decocting from the Pharmacy Department of Beijing Hospital of Traditional Chinese Medicine, Capital Medical University.
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Control group: Mesalazine enema treatment
Other Intervention Name(s)
Mesalazine enema is produced by Vifor AG Zweigniederlassung Medichemie Ettingen, National medicine approval H20150127.
Intervention Description
Mesalazine enema, 4g/tube, 1 tube each time, enema before bed, once a night, a total of 8 weeks of continuous treatment.
Primary Outcome Measure Information:
Title
Change from Modified Mayo Activity Index at 8 weeks of treatment
Description
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).
Time Frame
Evaluation will be made at baseline and 8 weeks of treatment.
Secondary Outcome Measure Information:
Title
Change from Ulcerative Colitis Endoscopic Index of Severity(UCEIS) at 8 weeks of treatment
Description
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.
Time Frame
Evaluation will be made at baseline and 8 weeks of treatment.
Title
Change from Endoscopic Baron score at 8 weeks of treatment
Description
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).
Time Frame
Evaluation will be made at baseline and 8 weeks of treatment.
Title
Change from Geboes Score at 8 weeks of treatment
Description
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.
Time Frame
Evaluation will be made at baseline and 8 weeks of treatment.
Title
Change from Evaluation of curative effect of traditional Chinese medicine syndrome at 8 weeks of treatment
Description
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.
Time Frame
Evaluation will be made at baseline and 2,4,8 weeks of treatment.
Title
Change from Quality of life score at 8 weeks of treatment
Description
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.
Time Frame
Evaluation will be made at baseline and 8 weeks of treatment.
Title
Change from Intestinal flora at 8 weeks of treatment
Description
Fresh feces are collected at baseline and 8 weeks of treatment, and the distribution of intestinal flora is detected by 16s rRNA sequencing technology.
Time Frame
Examination will be performed at baseline and 8 weeks of treatment.
Other Pre-specified Outcome Measures:
Title
Change from Inflammation and immune-related indicators in colonoscopy biopsy tissues at 8 weeks of treatment
Description
Colonoscopy biopsy tissues are collected at baseline and 8 weeks of treatment, and the Inflammation and immune-related indicators is detected by immumohistochemical staining.
Time Frame
Examination will be performed at baseline and 8 weeks of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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). 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Dou, Doctor
Phone
+8618810626167
Email
doudan0103@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xihan Zhu, Master
Phone
+8618810635443
Email
598827534@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luqing Zhao, Doctor
Organizational Affiliation
Beijing Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
City
Dongcheng
State/Province
Beijing
ZIP/Postal Code
10010
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29050646
Citation
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Results Reference
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PubMed Identifier
31300515
Citation
Jones 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.
Results Reference
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PubMed Identifier
28120842
Citation
Ahmad 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.
Results Reference
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PubMed Identifier
31020664
Citation
Wu 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.
Results Reference
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PubMed Identifier
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Citation
Li 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.
Results Reference
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Treatment of Ulcerative Colitis With Rectal Instillation of Qinghua Quyu Prescription(QHQYP)

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