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Trial of Tian Jiu Therapy for Allergic Rhinitis

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ClinicalTrials.gov Identifier: NCT02470845
Recruitment Status : Completed
First Posted : June 12, 2015
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
ZhaoXiang Bian, 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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis (AR) Drug: herbal patches of Tian Jiu group Drug: placebo patches of placebo-control group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Tian Jiu Therapy for Allergic Rhinitis
Study Start Date : July 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

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.
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.

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.
Drug: 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.

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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change of the Rhinitis Quality of Life Questionnaire (RQLQ) [ Time Frame: 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).

  2. Change in need for medication [ Time Frame: 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).



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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470845


Locations
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China
Hong Kong Baptist University Chinese Medicine Clinic
Hong Kong, China
Sponsors and Collaborators
Hong Kong Baptist University
Investigators
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Principal Investigator: Zhao Xiang Bian, Ph.D., M. D. School of Chinese Medicine, Hong Kong Baptist University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ZhaoXiang Bian, Professor, Director of Clinical Division,, Hong Kong Baptist University
ClinicalTrials.gov Identifier: NCT02470845    
Other Study ID Numbers: TJAR001
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases