Trial of Tian Jiu Therapy for Allergic Rhinitis

Allergic Rhinitis (AR) Clinical Trial

Official title:

A Randomized Controlled Trial of Tian Jiu Therapy for Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02470845
• Other study ID #: TJAR001
• Status: Completed
• Phase: N/A
• First received: May 17, 2015
• Last updated: March 14, 2017
• Start date: July 2014
• Est. completion date: September 2016

Study information

• Verified date: March 2017
• Source: Hong Kong Baptist University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Rhinitis (AR)
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• herbal patches of Tian Jiu group
The formula of herbal patch consists of BaiJieZi (Sinapis Semen), Yan Hu Suo(CorydulisRhizoma)?ZhiGan Sui (Kansui Radix)?Xi Xin (Asari Radix et rhizama) and Rengong She xiang(Moschus Artifactus) . The four herbs will be ground into powder, mixed thoroughlywith 20% BaiJieZi (Sinapis Semen), 25% Yan Hu Suo(CorydulisRhizoma), 15% ZhiGan Sui (Kansui Radix), and 40% Xi Xin (Asari Radix et rhizama), and the mixed powder will mix with fresh ginger juice in the ratio of 20g to 25 ml. The mixture will be made to a patch weighted as 2g and 1cm*1cm round size. 0.02g artificial She Xiang (Moschus Artifactus) will be added on top of each patch. Each patch will be applied on one acupoint.
• placebo patches of placebo-control group
The placebo patch consists of flour and edible pigments. These two ingredients will be mixed with water and made to patches weighted as 2g and 1cm*1cm round size.Each patch will be applied on one acupoint.

Locations

Country	Name	City	State
China	Hong Kong Baptist University Chinese Medicine Clinic	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Hong Kong Baptist University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of total nasal symptom score	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)	4 weeks
Secondary	Change of the Rhinitis Quality of Life Questionnaire (RQLQ)	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).	8 weeks
Secondary	Change in need for medication	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).	8 weeks