Trial of Tian Jiu Therapy for Allergic Rhinitis

NCT ID: NCT02470845

Last Updated: 2017-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2016-09-30

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.

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.

Conditions

Allergic Rhinitis (AR)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

herbal patches of Tian Jiu group

Intervention Type: DRUG

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-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.

Group Type: SHAM_COMPARATOR

placebo patches of placebo-control group

Intervention Type: DRUG

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hong Kong Baptist University

OTHER

Sponsor Role: lead

Responsible Party

ZhaoXiang Bian

Professor, Director of Clinical Division,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhao Xiang Bian, Ph.D., M. D.

Role: PRINCIPAL_INVESTIGATOR

School of Chinese Medicine, Hong Kong Baptist University

Locations

Hong Kong Baptist University Chinese Medicine Clinic

Hong Kong, , China

Countries

China

References

Kun W, Zhong LL, Dai L, Cheng CW, Lu AP, Bian ZX. Tian Jiu therapy for allergic rhinitis: study protocol for a randomized controlled trial. Trials. 2016 May 17;17(1):248. doi: 10.1186/s13063-016-1374-5.

Reference Type: DERIVED

PMID: 27189087 (View on PubMed)

Other Identifiers

TJAR001

Identifier Type: -

Identifier Source: org_study_id