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Probiotics-assisted Specific Immunotherapy with Artemisia annua Sublingual Drops for Allergic Rhinitis: A Prospective Randomized Controlled Clinical Study

Probiotics-assisted Specific Immunotherapy with Artemisia annua Sublingual Drops for Allergic Rhinitis: A Prospective Randomized Controlled Clinical Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119603
Enrollment
Unknown
Registered
2026-02-28
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

allergic rhinitis

Interventions

Artemisia annua sublingual drops combined with placebo treatment group:Artemisia annua sublingual drops combined with placebo
Artemisia annua sublingual drops combined with probiotics treatment group:Artemisia annua sublingual drops plus probiotics

Sponsors

Hohhot First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. All AR patients enrolled in this study had a history of Artemisia pollen allergic rhinitis. 2. Aged 18–60 years, male or female; 3. History of typical Artemisia pollen allergic rhinitis; seasonal AR diagnostic criteria referenced the Chinese Guidelines for Diagnosis and Treatment of Allergic Rhinitis (2022, Revised Edition); 4. Symptoms: Presence of two or more of the following: paroxysmal sneezing, watery nasal discharge, nasal itching, and nasal congestion. Symptoms persist daily or cumulatively for over one hour, potentially accompanied by ocular symptoms such as lacrimation, ocular itching, and ocular redness; 5. Signs: Commonly observed pallor and oedema of the nasal mucosa, with serous nasal discharge; 6. Allergen testing conducted at presentation: Positive skin prick test result for at least one Artemisia pollen allergen; 7. Patients with Artemisia pollen allergy experiencing symptoms lasting over 4 weeks during the preceding pollen dispersal season; 8. Voluntary participation and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with chronic allergic rhinitis, severe nasal septal deviation, sinusitis, or nasal polyps; 2. Patients with severe cardiac, hepatic, renal, or cerebral disease; 3. Pregnant or lactating women; 4. Use of tricyclic antidepressants, immunosuppressants/immunomodulators, or oral corticosteroids within 4 weeks prior to enrolment; 5. Individuals who have undergone prolonged antibiotic therapy within one month prior to enrolment; 6. Patients with a history of Clostridioides difficile infection within the preceding three months; 7. Patients who have undergone major surgery within the preceding three months; 8. Individuals with allergies to probiotics or other components; 9. Other circumstances deemed unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
At 1 year of treatment, the daily combined symptom and medication score (CSMS) was reduced by more than 50% from baseline.;

Secondary

MeasureTime frame
Symptom score based on Visual Analogue Scale (VAS);Total medication scores, TMS;Time to end and duration of symptoms;Routine blood tests;Peripheral blood cytokine;Gut microbiota;Nasal microbes;Feca and serum metapolites;Adverse events;

Countries

China

Contacts

Public ContactJunjing Zhang

Hohhot First Hospital

Zhang.jj@vip.163.com+86 135 0069 6309

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026