Trial of Tian Jiu Therapy for Allergic Rhinitis

Hong Kong Baptist University

Status: Completed

Conditions: Allergic Rhinitis (AR)

Treatments: Drug: placebo patches of placebo-control group; Drug: herbal patches of Tian Jiu group

Study type: Interventional

Funder types: Other

Identifiers

NCT02470845

TJAR001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 patients

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

136 participants in 3 patient groups

Tian Jiu group

Experimental group

Description:

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.

Treatment:

Drug: herbal patches of Tian Jiu group

Placebo-control group

Sham Comparator group

Description:

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.

Treatment:

Drug: placebo patches of placebo-control group

Waitlist-control group

No Intervention group

Description:

The waitlist-control group will receive no treatment during the first 4 weeks but, beginning with the 5th week this group will receive TJ treatment for four weeks as compensatory.