A Single-Arm Exploratory Study of NatureU Histra Disslove on Chronic Urticaria Symptoms (NUHISTRA)
20 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
19
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Hunan
-
Yongzhou, Hunan, Porcelana, 425300
- Dao County People's Hospital
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change From Baseline in Urticaria Control Test Score
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change From Baseline in Urticaria Activity Score 7
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
4 de octubre de 2024
Finalización primaria (Actual)
1 de noviembre de 2024
Finalización del estudio (Actual)
1 de noviembre de 2024
Fechas de registro del estudio
Enviado por primera vez
15 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
20 de mayo de 2026
Publicado por primera vez (Actual)
28 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
20 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Procesos Patológicos
- Enfermedad crónica
- Atributos de la enfermedad
- Enfermedades del sistema inmunológico
- Hipersensibilidad, Inmediata
- Hipersensibilidad
- Enfermedades de la piel
- Enfermedades De La Piel Vasculares
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades de la piel y del tejido conectivo
- Urticaria crónica
- Angioedema
- Urticaria
Otros números de identificación del estudio
- SP-CTI-DX006
- 2024080001 (Otro identificador: Ethics Committee of Dao County People's Hospital)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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