NCT02027194

Brief Summary

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.

  1. 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. 2.CS group will indicate a healthier body constitution pattern over the follow-up, when compared to those with YS and placebo group.
  3. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
298

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2012

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 6, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

March 13, 2015

Status Verified

March 1, 2015

Enrollment Period

2.2 years

First QC Date

January 2, 2014

Last Update Submit

March 12, 2015

Conditions

Allergic Rhinitis

Keywords

Allergic RhinitisChinese herbal medicineAdolescentsDouble-blindedRandomized controlled trial

Outcome Measures

Primary Outcomes (4)

  • Rhino-conjunctivitis Questionnaire (symptom severity)

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

    Baseline

  • Rhino-conjunctivitis Questionnaire (symptom severity)

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

    Immediately after intervention (1-2 min)

  • Rhino-conjunctivitis Questionnaire (symptom severity)

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

    1 month after intervention

  • Rhino-conjunctivitis Questionnaire (symptom severity)

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

    3 months after intervention

Secondary Outcomes (8)

  • Rhino-conjunctivitis Quality of Life Questionnaire

    Baseline

  • Constitution in Chinese Medicine Questionnaire

    Baseline

  • Rhino-conjunctivitis Quality of Life Questionnaire

    Immediately after intervention (1-2 min)

  • Rhino-conjunctivitis Quality of Life Questionnaire

    1 month after intervention

  • Rhino-conjunctivitis Quality of Life Questionnaire

    3 months after intervention

  • +3 more secondary outcomes

Other Outcomes (4)

  • Health assessment

    Baseline

  • Health assessment

    Immediately after intervention (1-2-min)

  • Health assessment

    1 month after intervention

  • +1 more other outcomes

Study Arms (3)

Cure-Allergic Rhinitis Syrup

EXPERIMENTAL

In syrup form, 20 ml once daily for 4 weeks

Drug: Cure-Allergic Rhinitis Syrup

Yu-ping-fung San

ACTIVE COMPARATOR

In syrup form, 20ml once daily for 4 weeks

Drug: Yu-ping-fung San

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Cure-Allergic Rhinitis SyrupDRUG

Delivered one bottle for two weeks to the participants twice

Also known as: CS group
Cure-Allergic Rhinitis Syrup
Yu-ping-fung SanDRUG

Delivered one bottle for 2-week usage to the participants twice

Also known as: YS group
Yu-ping-fung San
PlaceboDRUG

Delivered one bottle (wheat power with favors) for 2-week usage to the participants twice

Also known as: Placebo/Control
Placebo group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Nursing students in a full-time bachelor degree program in School of Nursing at The University under study;
  • They are diagnosed by Western medicine and/or TCM practitioner with allergic rhinitis, including those seasonal or perennial one for at least two years;
  • They have a body constitution of Cold and Yang-Deficiency, according to the TCM assessment;
  • They are aged 18 or above and able to speak Cantonese and/or Mandarin; and
  • They can understand written Chinese language, particularly the questionnaires used.

You may not qualify if:

  • A body constitution pattern of Hot and/or Yin-Deficiency, according to the TCM assessment;
  • Currently been taking long-term medications such as anti-hypertensive and psychiatric drugs;
  • Known medical history of co-morbidity of a recent acute and/or chronic disease such as heart, liver and lung disease, cancer, and/or mental illness;
  • Recently undergone major operation(s), are receiving chemotherapy and radiotherapy, or are going to be admitted into hospital over the study period; and
  • Known allergy history of Chinese herbal medicine .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, The Hong Kong Polytechnic University

Hung Hom, Kowloon, Hong Kong

Location

Related Publications (4)

  • Jung JW, Kang HR, Ji GE, Park MS, Song WJ, Kim MH, Kwon JW, Kim TW, Park HW, Cho SH, Min KU. Therapeutic effects of fermented red ginseng in allergic rhinitis: a randomized, double-blind, placebo-controlled study. Allergy Asthma Immunol Res. 2011 Apr;3(2):103-10. doi: 10.4168/aair.2011.3.2.103. Epub 2011 Feb 14.

    PMID: 21461249BACKGROUND

  • Yang SH, Yu CL, Chen YL, Chiao SL, Chen ML. Traditional Chinese medicine, Xin-yi-san, reduces nasal symptoms of patients with perennial allergic rhinitis by its diverse immunomodulatory effects. Int Immunopharmacol. 2010 Aug;10(8):951-8. doi: 10.1016/j.intimp.2010.05.008. Epub 2010 May 28.

    PMID: 20546945BACKGROUND

  • Chan, R.Y.P., & Chien, W.T. (2013). Concepts of body constitution, health and sub-health from traditional Chinese medicine perspective. World Journal of Translational Medicine, 2(3), 56-66. (doi:10.5528/wjtm.v2.i3.56).

    RESULT

  • Chan RY, Chien WT. The effects of two Chinese herbal medicinal formulae vs. placebo controls for treatment of allergic rhinitis: a randomised controlled trial. Trials. 2014 Jul 2;15:261. doi: 10.1186/1745-6215-15-261.

    PMID: 24986270RESULT

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Wai Tong Chien

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 2, 2014

First Posted

January 6, 2014

Study Start

June 1, 2012

Primary Completion

August 1, 2014

Study Completion

October 1, 2014

Last Updated

March 13, 2015

Record last verified: 2015-03

Locations

HK(1)