A Single-Arm Exploratory Study of NatureU Histra Dissolve on Chronic Urticaria Symptoms

NCT07611032 | Completed

• 2 other identifiers: SP-CTI-DX0062024080001
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Urticaria; Urticaria; Angioedema

Keywords

NatureU Histra Disslove; NatureU Yan; diamine oxidase; DAO; chronic urticaria; Urticaria Control Test; Urticaria Activity Score 7; Dermatology Life Quality Index

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Day 14, and Day 28

Secondary Outcomes (2)

• Change From Baseline in Urticaria Activity Score 7

  Baseline, Day 14, and Day 28

• Change From Baseline in Dermatology Life Quality Index

  Baseline, Day 14, and Day 28

Study Arms (1)

NatureU Histra Disslove

EXPERIMENTAL

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

Interventions

NatureU Histra Disslove DIETARY_SUPPLEMENT

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.

NatureU Histra Disslove

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OmniSolutions Laboratory Holdings Limited: lead

Study Sites (1)

Dao County People's Hospital

Yongzhou, Hunan, 425300, China

Location

MeSH Terms

Conditions

Chronic Urticaria; Urticaria; Angioedema

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The study was open-label with no masking.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants received NatureU Histra Disslove for 28 consecutive days in a single-arm self-controlled exploratory design.

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 28, 2026
• Study Start: October 4, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

CN (1)