An interventional study of NatureU Histra Disslove in Chronic Urticaria, Urticaria and Angioedema, sponsored by OmniSolutions Laboratory Holdings Limited. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by OmniSolutions Laboratory Holdings Limited · Not applicable, Interventional, and Other
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.
The study was designed as an exploratory human evaluation of a food product containing active diamine oxidase (DAO). Screening was conducted from August 29, 2024 through October 4, 2024. After investigator review of the inclusion and exclusion criteria, 19 adults with chronic urticaria symptoms were enrolled on October 4, 2024. Participants received NatureU Histra Disslove at the study center on Day 0 and took the product continuously for 28 days through Day 28. The protocol specified oral intake of one tablet 20 minutes before a main meal, preferably dinner. Outcome assessments included the Urticaria Control Test (UCT), Urticaria Activity Score 7 (UAS7), and Dermatology Life Quality Index (DLQI) at Day 0, Day 14, and Day 28. Safety monitoring included adverse event collection and laboratory safety assessment. The study was open-label, single-arm, and self-controlled, with no placebo or parallel control group. Analyses were based on participants who completed the study assessments.
194 studies on the registry are indexed under Chronic Urticaria; 46 are open to participants now.
This study's enrollment of 19 is below the median of 80 across 145 interventional studies indexed under Chronic Urticaria.
Browse Chronic Urticaria studies →OmniSolutions Laboratory Holdings Limited is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received NatureU Histra Disslove, one tablet orally once daily 20 minutes before a main meal for 28 consecutive days.
Dietary Supplement: NatureU Histra Disslove
NatureU Histra Disslove is a food product containing active diamine oxidase (DAO). Participants took one tablet orally once daily, 20 minutes before a main meal, preferably dinner, for 28 consecutive days.
Change From Baseline in Urticaria Control Test Score
The Urticaria Control Test (UCT) was used to assess urticaria control. UCT ranges from 0 to 16, with higher scores indicating better urticaria control. The primary endpoint was within-participant change from baseline after 28 days of product intake.
Time frame: Baseline, Day 14, and Day 28
Change From Baseline in Urticaria Activity Score 7
Urticaria Activity Score 7 (UAS7) was calculated from daily wheal and itch scores over 7 consecutive days. The total score ranges from 0 to 42, with lower scores indicating lower urticaria activity. The secondary endpoint was within-participant change from baseline after 28 days of product intake.
Time frame: Baseline, Day 14, and Day 28
Change From Baseline in Dermatology Life Quality Index
The Dermatology Life Quality Index (DLQI) was used to assess skin-disease-related quality of life. The total score ranges from 0 to 30, with higher scores indicating worse quality of life. The secondary endpoint was within-participant change from baseline after 28 days of product intake.
Time frame: Baseline, Day 14, and Day 28
Ran from Oct 2024 to primary completion in Nov 2024, 0 months.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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