Ulcerative Colitis (UC)Phase 1/2NCT06667934
Clinical Trial of Zuoqing SAN in Treating Ulcerative Colitis
A Phase 1/2 study testing Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night and Methalazine suppository was given rectally once a day in people with Ulcerative Colitis (UC), run by The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis (UC)
- What is being tested?
- Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night and Methalazine suppository was given rectally once a day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2024to 1 May 2025
- Phase
- Phase 1/2
- 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
Inclusion Criteria:① Clinically diagnosed UC; ② The severity of UC is mild to moderate.
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Exclusion Criteria:① The severity of UC is severe; ②patient with Severe liver, kidney, heart and brain diseases; ③ Patients with Chinese medicine allergy; ④ Pregnant or lactation patients.
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Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Ulcerative Colitis (UC)
- Being tested
- Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night, Methalazine suppository was given rectally once a day
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a nightDrug
Also called retained enema with Zuoqing powder , once a night
Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night
Methalazine suppository was given rectally once a dayDrug
Methalazine suppository was given rectally once a day
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night Receives: Drug: Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night |
| Control Group | Active comparator | Methalazine supposers anal once a day Receives: Drug: Methalazine suppository was given rectally once a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms: frequency of stool
Symptoms: frequency of stool in one day, or Daily number of bowel movements
Measured: Follow-up for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start30 Oct 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heng Deng, The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667934
- Sponsor's protocol ID
- 2024AH-98-01
- Other IDs
- 2021AH9987
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We can share IPD with other researchers. When our research results are phased, other research groups can watch and participate in the discussion of the research plan.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Zuoqing SAN in Treating Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT06667934
- Acronym / sponsor ID
- 2024AH-98-01
- Conditions
- Ulcerative Colitis (UC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Anhui University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 31 Oct 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Drug: Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a nightZuoqing powder was dissolved in 100ml normal saline, retained enema, once a night |
| Control Group | Active comparator | Drug: Methalazine suppository was given rectally once a dayMethalazine supposers anal once a day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a nightAlso: retained enema with Zuoqing powder , once a nightZuoqing powder was dissolved in 100ml normal saline, retained enema, once a night | Drug | Study Group |
| Methalazine suppository was given rectally once a dayMethalazine suppository was given rectally once a day | Drug | Control Group |
Primary outcome
Symptoms: frequency of stool
Time frame: Follow-up for 6 months
Symptoms: frequency of stool in one day, or Daily number of bowel movements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: Yes. We can share IPD with other researchers. When our research results are phased, other research groups can watch and participate in the discussion of the research plan.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night and Methalazine suppository was given rectally once a day in people with Ulcerative Colitis (UC), run by The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heng Deng, Dr. (+8613335510159, dengheng23@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms: frequency of stool (time frame: Follow-up for 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2024.