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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||136 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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)
- 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).
- 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).
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
|Hong Kong Baptist University Chinese Medicine Clinic|
|Hong Kong, China|
|Principal Investigator:||Zhao Xiang Bian, Ph.D., M. D.||School of Chinese Medicine, Hong Kong Baptist University|