A Randomized Controlled Trial of Tian Jiu Therapy for Allergic Rhinitis
Overview
- Phase
- Not Applicable
- Intervention
- herbal patches of Tian Jiu group
- Conditions
- Allergic Rhinitis (AR)
- Sponsor
- Hong Kong Baptist University
- Enrollment
- 136
- Locations
- 1
- Primary Endpoint
- Change of total nasal symptom score
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
ZhaoXiang Bian
Professor, Director of Clinical Division,
Hong Kong Baptist University
Eligibility Criteria
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.
Arms & Interventions
Tian Jiu group
The TJ group will undergo a 4-week treatment with herbal patches one session per week and a 4-week post-treatment follow-up, of one assessment session per week. Participants in the TJ group will be treated with herbal patches of Tian Jiu group on five acupoints on the back.
Intervention: herbal patches of Tian Jiu group
Placebo-control group
The placebo-control group will undergo a 4-week treatment with placebo patches one session per week and a 4-week post-treatment follow-up, of one assessment session per week. Participants in this group will be treated with placebo patches of placebo-control group on the same acupionts as the TJ group.
Intervention: placebo patches of placebo-control group
Outcomes
Primary Outcomes
Change of total nasal symptom score
Time Frame: 4 weeks
The change in the weekly average of total nasal symptom score (TNSS) recorded in participants' diaries from baseline（ Week 0） to end of the treatment（ Week 4）and post-treatment follow-up ( Week 8)
Secondary Outcomes
- Change in need for medication(8 weeks)
- Change of the Rhinitis Quality of Life Questionnaire (RQLQ)(8 weeks)