A Single-Arm Exploratory Study of NatureU Histra Disslove on Chronic Urticaria Symptoms (NUHISTRA)

May 20, 2026 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Yongzhou, Hunan, China, 425300
        • Dao County People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participants who signed informed consent before the study and understood the study content, procedures, and possible adverse reactions.
  2. Adults diagnosed with chronic urticaria by a dermatologist based on clinical symptoms and medical history.
  3. Age 18 to 65 years.
  4. 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.
  5. Participants willing to maintain normal healthy routines during the study, avoid alcohol, and avoid foods likely to trigger allergic reactions.

Exclusion Criteria:

  1. Severe internal organ disease, including heart disease, kidney disease, or other serious disease that could affect product metabolism.
  2. Known allergy or intolerance to any ingredient of the study product.
  3. Other skin disease or systemic disease that could affect urticaria manifestations.
  4. Participation in another clinical trial or use of prohibited drug treatment.
  5. Heavy smoking, alcohol abuse, or other lifestyle factors that could affect study results.
  6. Severe psychological disorder or cognitive impairment that could affect compliance.
  7. Inability to follow study dietary restrictions or requirements because of religious or personal reasons.
  8. Abnormal blood routine, liver function, kidney function, or other laboratory test results outside the normal range.
  9. 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.
  10. Any other factor judged by the investigator to make participation inappropriate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NatureU Histra Disslove
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Urticaria Control Test Score
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Urticaria Activity Score 7
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OmniSolutions Laboratory Holdings Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2024

Primary Completion (Actual)

November 1, 2024

Study Completion (Actual)

November 1, 2024

Study Registration Dates

First Submitted

May 15, 2026

First Submitted That Met QC Criteria

May 20, 2026

First Posted (Actual)

May 28, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP-CTI-DX006
  • 2024080001 (Other Identifier: Ethics Committee of Dao County People's Hospital)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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