Trial of Tian Jiu Therapy for Allergic Rhinitis

NCT02470845 | Completed DMC

• 1 other identifier: TJAR001
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis (AR)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change of the Rhinitis Quality of Life Questionnaire (RQLQ)

  8 weeks

• Change in need for medication

  8 weeks

Study Arms (3)

Tian Jiu group

EXPERIMENTAL

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

Placebo-control group

SHAM COMPARATOR

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

Waitlist-control group

NO INTERVENTION

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.

Interventions

herbal patches of Tian Jiu group 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.

Tian Jiu group

placebo patches of placebo-control group 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.

Placebo-control group

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hong Kong Baptist University: lead

Study Sites (1)

Hong Kong Baptist University Chinese Medicine Clinic

Hong Kong, China

Location

Related Publications (1)

• 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.

  PMID: 27189087 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Zhao Xiang Bian, Ph.D., M. D.

  School of Chinese Medicine, Hong Kong Baptist University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of Clinical Division,

Study Record Dates

• First Submitted: May 17, 2015
• First Posted: June 12, 2015
• Study Start: July 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 15, 2017

Record last verified: 2017-03

Locations

CN (1)