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Clinical Trial of Zuoqing SAN in Treating Ulcerative Colitis

NCT ID: NCT06667934

Last Updated: 2024-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-30

Study Completion Date

2025-05-01

Brief Summary

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The exact efficacy of Zuoqing SAN enema in the treatment of Ulcerative colitis (UC) has been clinically verified. In this study, Zuoqing SAN was used to treat UC patients with large intestine damp-heat syndrome, and the traditional chinese medicine (TCM) syndrome type was large intestine damp-heat syndrome. The changes of symptoms and signs of patients before and after treatment were observed and compared, and the clinical efficacy of Zuoqing SAN in the treatment of UC large intestine damp-heat syndrome was evaluated by combining the changes of patients' symptoms, related blood indicators, improved Mayo total score, overall syndrome efficacy, clinical comprehensive efficacy and other aspects. By replicating the rat UC model, the effects of Zuoqing SAN on general survival state, colonic gross appearance and histopathological changes, related inflammatory factors, peroxisome proliferator-activated receptor γ (PPAR-γ) /nuclear factor kappa-B（NF-κB) /signal transducerand activator of transcription 1 (STAT1) pathway, macrophage M1, M2 phenotype and microangiogenesis were observed in UC rats. Thus, the specific mechanism of Zuoqing SAN in the treatment of UC was revealed. In this study, the therapeutic effect of Zuoqing Powder on UC was investigated through clinical and animal experiments, and the specific mechanism of action was studied.

Detailed Description

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Conditions

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Ulcerative Colitis (UC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study Group

Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night

Group Type EXPERIMENTAL

Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night

Intervention Type DRUG

Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night

Control Group

Methalazine supposers anal once a day

Group Type ACTIVE_COMPARATOR

Methalazine suppository was given rectally once a day

Intervention Type DRUG

Methalazine suppository was given rectally once a day

Interventions

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Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night

Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night

Intervention Type DRUG

Methalazine suppository was given rectally once a day

Methalazine suppository was given rectally once a day

Intervention Type DRUG

Other Intervention Names

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retained enema with Zuoqing powder , once a night

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Heng Deng

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Heng Deng, Dr.

Role: CONTACT

Phone: +8613335510159

Email: [email protected]

Other Identifiers

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2021AH9987

Identifier Type: OTHER

Identifier Source: secondary_id

2024AH-98-01

Identifier Type: -

Identifier Source: org_study_id