A Single-Arm Exploratory Study of NatureU Histra Disslove on Chronic Urticaria Symptoms (NCT07611032) | Clinical Trial Compass
CompletedNot Applicable
A Single-Arm Exploratory Study of NatureU Histra Disslove on Chronic Urticaria Symptoms
China19 participantsStarted 2024-10-04
Plain-language summary
This was a single-center, open-label, single-arm, exploratory self-controlled study evaluating NatureU Histra Disslove in adults with chronic urticaria symptoms. Twenty-four participants were screened, 19 participants were enrolled, and 19 participants completed the study and were included in the effectiveness analysis. Participants took one tablet of the study product orally once daily, 20 minutes before a main meal, for 28 consecutive days. Urticaria Control Test, Urticaria Activity Score 7, and Dermatology Life Quality Index assessments were performed at baseline, Day 14, and Day 28. Safety was monitored during the study.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants who signed informed consent before the study and understood the study content, procedures, and possible adverse reactions.
. Adults diagnosed with chronic urticaria by a dermatologist based on clinical symptoms and medical history.
. Age 18 to 65 years.
. Participants with typical wheals with itching and/or angioedema symptoms of chronic urticaria and either a Urticaria Activity Score 7 of at least 7 or a Urticaria Control Test score below 12.
. Participants willing to maintain normal healthy routines during the study, avoid alcohol, and avoid foods likely to trigger allergic reactions.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Urticaria Control Test Score