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Completed

NCT Number: NCT02470845

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.

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Key information

Conditions

Allergic Rhinitis (AR) Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hong Kong Baptist University Chinese Medicine Clinic

Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Hong Kong Baptist University

Other

Registry information

Official study title

A Randomized Controlled Trial of Tian Jiu Therapy for Allergic Rhinitis

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 12, 2015
Registry last updated
Mar 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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