Trial of Tian Jiu Therapy for Allergic Rhinitis
This trial is active, not recruiting.
|Condition||allergic rhinitis (ar)|
|Treatments||herbal patches of tian jiu group, placebo patches of placebo-control group|
|Sponsor||Hong Kong Baptist University|
|Start date||July 2014|
|End date||September 2016|
|Trial size||136 participants|
|Trial identifier||NCT02470845, TJAR001|
The aim of this study is to investigate the efficacy and safety of Tian Jiu in the treatment of allergic rhinitis compared with placebo and waitlist patients in Hong Kong.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Change of total nasal symptom score
time frame: 4 weeks
Change of the Rhinitis Quality of Life Questionnaire (RQLQ)
time frame: 8 weeks
Change in need for medication
time frame: 8 weeks
Male or female participants at least 3 years old.
Inclusion Criteria: - Positive skin prick tests - High circulating levels of allergen-specific IgE antibody detected by a specific blood test for allergy called radioallergosorbent test (RAST)] - Clinical history or allergen to have been identified - Nasal provocation (test) Exclusion Criteria: - Allergic asthma, moderate to severe atopic dermatitis, autoimmune disorders, severe chronic inflammatory diseases, history of anaphylactic reactions, hypersensitivity to cetirizine or related drugs, specific immunotherapy during the past 3 years or planned in the next 2 years, pregnancy or breastfeeding.
|Official title||A Randomized Controlled Trial of Tian Jiu Therapy for Allergic Rhinitis|
|Principal investigator||Zhao Xiang Bian, Ph.D., M. D.|
|Description||This will be a prospective, randomized, single-blinded, controlled trial in patients with AR. After a one-week run-in period, eligible subjects will be randomly assigned to the Tian Jiu group, placebo-control group and waitlist-control group. The TJ and placebo-control groups will undergo a 4-week treatment with one session per week and one 4-week post-treatment follow-up. Participants in the waitlist-control group will not receive any treatment during the first 4 weeks but will be required to be assessed. The total study period will be nine weeks.|
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