Trial of Tian Jiu Therapy for Allergic Rhinitis

Not Applicable

Completed

• Conditions: Allergic Rhinitis (AR)
• Interventions: Drug: herbal patches of Tian Jiu group; Drug: placebo patches of placebo-control group

• Registration Number: NCT02470845
• Lead Sponsor: Hong Kong Baptist University

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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-05-17
• Study First Submitted QC: 2015-06-09
• Study First Posted: 2015-06-12
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-14
• Last Update Posted: 2017-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tian Jiu group	herbal patches of 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.
Placebo-control group	placebo patches of 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.

Primary Outcome Measures

Name	Time	Method
Change of total nasal symptom score	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 Outcome Measures

Name	Time	Method
Change in need for medication	8 weeks	The change in need for medication will be measured using an RM score (RMS), by comparing the baseline (Week 0) with the scores within treatment (Week 2, 3), end of treatment( Week 4) and post-treatment follow-up ( Week 8).
Change of the Rhinitis Quality of Life Questionnaire (RQLQ)	8 weeks	The change in symptoms will be measured using the Rhinitis Quality of Life Questionnaire (RQLQ), by comparing the baseline( Week 0) with the scores within treatment (Week 2, 3), end of treatment( Week 4) and post-treatment follow-up ( Week 8).

Trial Locations

Locations (1)

Hong Kong Baptist University Chinese Medicine Clinic; 🇨🇳 Hong Kong, China