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临床试验/NCT02027194
NCT02027194已完成1 期

Effects of Chinese Herbal Medicine for Treatment of Allergic Rhinitis: A Randomized Controlled Trial

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 298 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
298
试验地点
1
主要终点
Rhino-conjunctivitis Questionnaire (symptom severity)

研究概览

简要总结

The aim of this study is to test and compare the effectiveness between three groups - Cure-Allergic Rhinitis Syrup (CS), Yuk ping fung San (YS) and placebo groups - of adolescents (nursing students) with Allergic Rhinitis (AR) in improving their symptoms of AR, body constitution pattern and health-related quality of life.

• The hypothesis are to test the effectiveness of the CS treatment on these students' AR symptoms and quality of life at immediately, one month and two months after completion of the 4-week intervention, when compared with the YS treatment and placebo group.

  1. Cure-Allergic Rhinitis Syrup (CS) group will show significantly reduction of AR symptoms over the 2-month follow-up, when compared to those in YS and placebo groups.
  2. CS group will indicate a healthier body constitution pattern over the follow-up, when compared to those with YS and placebo group.
  3. CS group will indicate significantly greater improvement of their quality of life over 2-month follow-up, when compared to those with YS and placebo group.

详细描述

Background

  • Rhinitis (AR) is one of the most concerned public health problems worldwide, resulting from an inflammation of nasal membranes.
  • Nursing students is one of the high risk groups, particularly when performing clinical practicum in hospitals in which they would contact with multiple allergens such as micro-organisms, detergents, chemical agents, and frequently used powdered latex gloves. More than 10% of these adolescents would present consistent AR symptoms such as nasal congestion, sneezing and sleep problems and In turn, these symptoms could affect their quality of life and academic performance.
  • Non-compliance to medication or refusals to medical advice was common due to lack of efficacy, side effects, fear of being habit-forming, and/or expensive medical costs; and thus many preferred an alternative therapy for improved symptoms and bodily condition, and even full recovery.
  • Chinese medicine treats the disease from the root, which is a complementary and alternative approach for holistic convalescence by changing unhealthy body constitution (health status) to healthy. However, little scientific evidence has been established for the treatment of AR with Chinese herbal medicine.
  • This study aims to test the effects of two alternative treatments of Chinese herbal medicine, including Cure-Allergic Rhinitis Syrup (CS) and Yuk ping fung San, when compared with a placebo (i.e., wheat syrup with similar taste and smell) group, in reducing university nursing students' AR symptom severity and improving their quality of life and body constitution.

Methodology

  • A double-blind randomized controlled trial with repeated-measures, three parallel groups design is adopted.
  • Assessment and follow-ups would be taken place in an Integrative Health Clinic of The University under study.
  • Stratified random sampling method in terms of the students' years of illness onset and gender has been used to allocate the subjects into one of the three study groups.
  • Participants, assessor and researcher are concealed and blinded to the random group allocation, which would be performed by an independent clinic nurse.
  • In order to maintain complete blinding, a clinic nurse will also administer the herbal medicine and keep the name list locked, and thus being confidential.
  • Participants would be recruited from all of five full-time undergraduate nursing programs in School of Nursing of The University. After their eligibility for inclusion checked and baseline measurement performed with informed consent obtained, the participants would be grouped in terms of duration of the illness (0-2 years, 2-5 years and 5 or above years) and gender and then each would draw one labeled card from an opaque envelope (1=CS, 2=YS and 3=Placebo) from the clinic nurse to allocate them into one of the three groups.
  • Quality of life and symptom severity would be measured with self-administered questionnaires, and body constitution assessment would be performed by an Traditional Chinese medicine (TCM) practitioner, at baseline and immediately, one-month and three-month after the 4-week intervention.

Sampling

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Cure-Allergic Rhinitis Syrup

Experimental

In syrup form, 20 ml once daily for 4 weeks

干预措施: Cure-Allergic Rhinitis Syrup (Drug)

Yu-ping-fung San

Active Comparator

In syrup form, 20ml once daily for 4 weeks

干预措施: Yu-ping-fung San (Drug)

Placebo group

Placebo Comparator

In syrup form (wheat powder with ginger and flavors), 20 ml once daily for 4 weeks

干预措施: Placebo (Drug)

结局指标

主要结局

Rhino-conjunctivitis Questionnaire (symptom severity)

时间窗: 3 months after intervention

10cm visual analogue scale used in a 28-item questionnaire to evaluate their symptoms severity.

次要结局

  • Rhino-conjunctivitis Quality of Life Questionnaire(3 months after intervention)
  • Constitution in Chinese Medicine Questionnaire(3 month after intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chien Wai-Tong

Professor

The Hong Kong Polytechnic University

研究点 (1)

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