A Single-Arm Exploratory Study of NatureU Histra Disslove on Chronic Urticaria Symptoms (NUHISTRA)
20. maj 2026 opdateret af: OmniSolutions Laboratory Holdings Limited
A Single-Center, Open-Label, Single-Arm Exploratory Self-Controlled Study of NatureU Histra Disslove on Urticaria Control, Urticaria Activity, and Dermatology Quality of Life in Adults With Chronic Urticaria Symptoms
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
19
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Hunan
-
Yongzhou, Hunan, Kina, 425300
- Dao County People's Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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:
- Severe internal organ disease, including heart disease, kidney disease, or other serious disease that could affect product metabolism.
- Known allergy or intolerance to any ingredient of the study product.
- Other skin disease or systemic disease that could affect urticaria manifestations.
- Participation in another clinical trial or use of prohibited drug treatment.
- Heavy smoking, alcohol abuse, or other lifestyle factors that could affect study results.
- Severe psychological disorder or cognitive impairment that could affect compliance.
- Inability to follow study dietary restrictions or requirements because of religious or personal reasons.
- Abnormal blood routine, liver function, kidney function, or other laboratory test results outside the normal range.
- Population for whom the product was contraindicated, including minors, participants planning pregnancy, pregnant or lactating participants, participants with liver or kidney disease history, and participants taking long-term medication.
- Any other factor judged by the investigator to make participation inappropriate.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: NatureU Histra Disslove
Participants received NatureU Histra Disslove, one tablet orally once daily 20 minutes before a main meal for 28 consecutive days.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Urticaria Control Test Score
Tidsramme: Baseline, Day 14, and Day 28
|
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.
|
Baseline, Day 14, and Day 28
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline in Urticaria Activity Score 7
Tidsramme: Baseline, Day 14, and Day 28
|
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.
|
Baseline, Day 14, and Day 28
|
|
Change From Baseline in Dermatology Life Quality Index
Tidsramme: Baseline, Day 14, and Day 28
|
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.
|
Baseline, Day 14, and Day 28
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
4. oktober 2024
Primær færdiggørelse (Faktiske)
1. november 2024
Studieafslutning (Faktiske)
1. november 2024
Datoer for studieregistrering
Først indsendt
15. maj 2026
Først indsendt, der opfyldte QC-kriterier
20. maj 2026
Først opslået (Faktiske)
28. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SP-CTI-DX006
- 2024080001 (Anden identifikator: Ethics Committee of Dao County People's Hospital)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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