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A multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of Yiqi Jiemin Decoction in the treatment of moderate to severe allergic rhinitis (lu

A multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of Yiqi Jiemin Decoction in the treatment of moderate to severe allergic rhinitis (lu

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006831
Enrollment
Unknown
Registered
2022-11-27
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-03-06

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

Conditions

allergic rhinitis

Interventions

control group:Yiqi Jiemin Decoction granules were simulated, one bag per time, orally administered twice a day for 14 consecutive days.
Low dose group:Granules made of 2/3 of the original prescription of Yiqi Jiemin Decoction, 1 bag per time, oral administration, twice a day, 14 consecutive days
High dose group:Granules made from the original dosage of Yiqi Jiemin Decoction, one bag per time, oral, twice a day, for 14 consecutive days

Sponsors

Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: a. Age = 18, = 65; b. Clinical symptoms: two or more of the symptoms, such as itching, sneezing, water like nasal discharge, and nasal congestion, occur in the nose, and the symptoms persist or accumulate for more than 1 hour every day, even accompanied by eye itching, tears, conjunctival congestion and other eye symptoms; c. The severity of symptoms is assessed as moderate or severe, that is, the symptoms are severe or severe, which has a significant impact on the quality of life. The onset of symptoms is greater than 4d/week, and = 4 consecutive weeks d. Skin prick test and serum specific IgE positive are at least consistent with one of the two indicators e. Obtain the informed consent of the patient and be willing to participate in the experiment; f. The liver and kidney function of the patient is normal, so as to avoid the error caused by abnormal liver and kidney function damage after taking traditional Chinese medicine; g. The patient has a good mental status, and can objectively and accurately express their own symptoms and treatment effects.

Exclusion criteria

Exclusion criteria: a. The patient is in the acute attack period of asthma and cardiovascular and cerebrovascular diseases, or suffers from immunodeficiency disease, head and face trauma, tumor, or organ transplantation; b. Women in pregnancy or lactation; c. Patients who are using glucocorticoid (including oral and local external use) for more than one week; d. Those who receive other clinical trials within 30 days.

Design outcomes

Primary

MeasureTime frame
Nasal Symptom Rating Scale;

Secondary

MeasureTime frame
Visual analog scale;Nasal endoscopic nasal sign score;Rhinoconjunctivitis Daily Quality of Life Questionnaire;

Countries

China

Contacts

Public ContactZhanfeng YAN
15210682430@163.com15210682430

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026