- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02470845
Trial of Tian Jiu Therapy for Allergic Rhinitis
March 14, 2017 updated by: ZhaoXiang Bian, Hong Kong Baptist University
A Randomized Controlled Trial of Tian Jiu Therapy for Allergic Rhinitis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
136
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong, China
- Hong Kong Baptist University Chinese Medicine Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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.
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Sham Comparator: 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.
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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.
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No Intervention: Waitlist-control group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of total nasal symptom score
Time Frame: 4 weeks
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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)
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of the Rhinitis Quality of Life Questionnaire (RQLQ)
Time Frame: 8 weeks
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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).
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8 weeks
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Change in need for medication
Time Frame: 8 weeks
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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).
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8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zhao Xiang Bian, Ph.D., M. D., School of Chinese Medicine, Hong Kong Baptist University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
September 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
May 17, 2015
First Submitted That Met QC Criteria
June 9, 2015
First Posted (Estimate)
June 12, 2015
Study Record Updates
Last Update Posted (Actual)
March 15, 2017
Last Update Submitted That Met QC Criteria
March 14, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TJAR001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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