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NCT Number: NCT05780723

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

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

Dongcheng, Beijing Municipality, 100010, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Treatment group: Rectal instillation of QHQYP

Drug

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.

Other names: QHQYP is prepared by unified decocting from the Pharmacy Department of Beijing Hospital of Traditional Chinese Medicine, Capital Medical University.

Control group: Mesalazine enema treatment

Drug

Mesalazine enema, 4g/tube, 1 tube each time, enema before bed, once a night, a total of 8 weeks of continuous treatment.

Other names: Mesalazine enema is produced by Vifor AG Zweigniederlassung Medichemie Ettingen, National medicine approval H20150127.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

    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.

  2. Change from Endoscopic Baron score at 8 weeks of treatment

    Time frame: Evaluation will be made at baseline and 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).

  3. Change from Geboes Score at 8 weeks of treatment

    Time frame: Evaluation will be made at baseline and 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.

  4. 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.

    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.

  5. Change from Quality of life score at 8 weeks of treatment

    Time frame: Evaluation will be made at baseline and 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.

  6. Change from Intestinal flora at 8 weeks of treatment

    Time frame: Examination will be performed at baseline and 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.

Other outcomes

  1. Change from Inflammation and immune-related indicators in colonoscopy biopsy tissues at 8 weeks of treatment

    Time frame: Examination will be performed at baseline and 8 weeks of treatment.

    Colonoscopy biopsy tissues are collected at baseline and 8 weeks of treatment, and the Inflammation and immune-related indicators is detected by immumohistochemical staining.

Sponsors and collaborators

Lead sponsor

Beijing Hospital of Traditional Chinese Medicine

Other

Registry information

Official study title

A Randomized Controlled Study of Qinghua Quyu Prescription Rectal Instillation for the Treatment of Ulcerative Colitis

Acronym: QHQYP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 22, 2023
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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