allergic rhinitis(AR)
Conditions
Interventions
Treatment group:Chinese herbal medicine of 'enrich earth to engender metal' method
Treatment group:Placebo of Levocetirizine oral solusion
control group:Levocetirizine oral solution
control group:Placebo of Chinese herbal compound granule of 'enrich earth to engender metal' method
Sponsors
Otorhinolaryngology department, Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Participants shall accord with the western medicine and Chinese Medicine diagnostic criteria of allergic rhinitis (AR). In addition, they shall conform to persistent allergic rhinitis, and also be eligible for lung -spleen qi deficiency in Chinese Medicine; 2. Aged 18 to 65 years male and female; 3. Participants are informed written consent and volunteer to participate in the study; 4. Participants can complete the case report forms independently,and take the blood and stood specimen according to the instructions. Note: Chinese Medicine Diagnostic Criteria of AR (Reference: China Association of Chinese Medicine, Diagnosis and Treatment Guidelines in Traditional Chinese Medicine for Common Otolaryngology Disease, Chinese Traditional Chinese Medicine Publishing House, Beijing, China, 2012:17-18.): (1) History: Patients :may have allergic history or family history; (2) Clinic symptoms: The characteristics of clinic symptoms are suddenly and repeatedly. The main symptoms of AR are nasal itch, paroxysmal sneezing, watery rhinorrhea and nasal congestion. Sometimes may accompany with eye itching, pharyngeal itching, palatine itching; (3) Sign: Period of onset, the nasal mucosa is pale, gray, pale blue or red. Nasal turbinate congestion and nasal cavity is filled with watery discharge. All of these signs are unapparent during intermission time; (4) Other laboratory tests: Immunological tests such as skin prick test, serum IgE test is helpful to diagnose. Western Medicine Diagnostic Criteria of AR(Reference:Subspecialty Group of Rhinology Editorial Board of Chinese Journal of Otorhinolaryngology Head and Neck Surgery, Subspecialty Group of Rhinology, Society of Otorhinolaryngology Head and Neck Surgery, Chinese Medical Association, Guidelines for diagnosis and treatment of allergic rhinitis(2015, Tianjin),Chinese Journal of Otorhinolaryngology Head and Neck Surgery, 2016,44(12): 977-978.); (1)Symptoms: Two or more symptoms such as sneezing, watery rhinorrhea, nasal itching, nasal congestion occurs and be persisted or accumulated more than 1 hours per day. Sometimes may accompany with eye itch, tears and red eyes; (2)Signs: The nasal mucosa is pale and edematous. Nasal secretion is watery; (3)Allergen test: At least one kind of skin prick test or/and serum specific IgE test is positive.
Exclusion criteria
Exclusion criteria: 1. Similar nasal diseases like acute rhinitis, vasomotor rhinitis, autonomic nervous rhinitis, eosinophilic nonallergic rhinitis, and allergic sinusitis; 2. Pregnancy women. Trial will be suspended if the participant is pregnant; 3. Participants can not fully cooperate with the trial and investigate due to mental or behavioral disorders; 4. Participants who frequently change their work place result in hard to be follow-up; 5. Participants who driver or work high above the ground.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| total nasal symptom score(TNSS); | — |
Secondary
| Measure | Time frame |
|---|---|
| * the standardized version of the Rhinoconjunctivitis Quality of Life Questionnaire ( RQLQ(S));AR attack frequency and duration during the study period;cytokine iterleukin-4;cytokine iterleukin-17;interferon-?;TGF-ß;fecal bacteria; | — |
Countries
China
Contacts
Public ContactYunying Li
Guangdong Provincial Hospital of Chinese Medicine
Outcome results
None listed