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Pilot Study on Traditional Chinese Medicine and Food Allergy (TCMFA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02490813
Recruitment Status : Recruiting
First Posted : July 7, 2015
Last Update Posted : February 22, 2019
Chinese University of Hong Kong
Information provided by (Responsible Party):
Hong Kong Sanatorium & Hospital

Tracking Information
First Submitted Date  ICMJE July 2, 2015
First Posted Date  ICMJE July 7, 2015
Last Update Posted Date February 22, 2019
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2015)
Tolerance to existing allergen [ Time Frame: 8 weeks ]
subjects will be accessed on tolerance to existing allergen via opened oral food challenge
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02490813 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2015)
  • Skin prick test result [ Time Frame: 8 weeks ]
    Skin prick test result to existing allergen
  • Blood test - IgE result [ Time Frame: 8 weeks ]
    Specific IgE test result to existing allergen
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Pilot Study on Traditional Chinese Medicine and Food Allergy
Official Title  ICMJE Pilot Study on Traditional Chinese Medicine and Food Allergy
Brief Summary

Recently, there has been an increasing interest in using traditional Chinese medicine for food allergy. The Harvard group has successfully demonstrated the Food Allergy Herbal Formula - FAHF2 completely blocked peanut-induced anaphylaxis in a murine model, and currently being studied in human. Therefore, in collaboration with the Institute of Chinese Medicine, CUHK, the investigators have developed a more simplified Chinese herbal formula - X (CHFX), containing four food-grade Chinese herbs, Wu-mei (Fructus Pruni Mume); Ling-zhi (Gonoderma); Huang-bai (Cortex Phellodendron) and Zhi-su (Perilla frutescens).

In the present study, the investigators would like to examine whether there is reduction in allergic symptoms in food challenge after administering the CHFX for 8 weeks. There will be pre- and post- CHFX food challenges and other related tests.

Detailed Description

The investigators aim to recruit 24 subjects for the present study. Subjects will be randomized into two groups, control group (n=12) and treatment group (n=12). At recruitment all subjects will be required to stop anti-allergic medicines and Chinese medicines as a wash out period for two weeks (week 1 and week 2). They will be required to keep a record of their symptoms and peak flow rates twice daily throughout the entire study. Skin prick test will be performed with a panel of commercially available skin test solutions for cod, shrimp and crab (ALK). Total and specific IgE as well as total and specific IgG4 for fish and shellfish will be measured (by the HKSH laboratory or CUHK laboratory). Graded open cod, shrimp or crab challenge will be performed as described later at HKSH in each patient to determine the baseline tolerance level to fish or shellfish, using freeze-dried cod, shrimp or crab as appropriate.

After determining the baseline tolerance level, subjects in the treatment group will take 2 grams of the CHFX or placebo daily for 8 weeks (week 4 to week 11). The placebo powder consists of food grade medicinal starch blended with coloring agent. After the 8 weeks of treatment, skin prick tests, blood tests as at baseline and oral challenges will be repeated (week 12). During the study subjects will be requested to consume their normal diet but avoiding fish and shellfish, with no consumption of any other Chinese herbal medication. They can take anti-allergic medicines as necessary but will note when medicines are taken in their symptom and peak flow diary.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Allergy to Fish
  • Allergy to Shrimp
  • Allergy to Crab
Intervention  ICMJE
  • Dietary Supplement: Treatment - Chinese Herbal Formula - X
    Wu Mei (Fructus Pruni Mume), Ling Zhi (Gonoderma), Huang Bai (Cortex Phellodendron), and Zhi Su (Perilla frutescens).
  • Dietary Supplement: Placebo
    Placebo will be starch with colorings
Study Arms  ICMJE
  • Placebo Comparator: Control
    This arm will receive the placebo.
    Intervention: Dietary Supplement: Placebo
  • Experimental: Treatment - Chinese Herbal Formula - X
    This arm will receive the Chinese Herbal Formula - CHFX as treatment to their existing fish, shrimp or crab allergy.
    Intervention: Dietary Supplement: Treatment - Chinese Herbal Formula - X
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 6, 2015)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 8 years or older with a history of allergic reaction to cod, shrimp or crab, manifested by any of the following: urticaria, angioedema, asthma or anaphylaxis, within 60 mins of ingestion.
  • Having a positive skin prick test to the cod, shrimp or crab as defined by a weal diameter 3 mm greater than the diluent control.
  • Having a positive oral challenge with freeze-dried cod, shrimp or crab.
  • Asthma must be under control with a FEV1 of at least 80% predicted value.
  • Aspirin, anti-histamines/anti-allergic medicines and antidepressants are not permitted for 3 days, one week and two weeks, respectively, before skin testing or oral food challenge.

Exclusion Criteria:

  • Pregnancy.
  • Requiring systemic glucocorticoids, beta-blockers and ACE inhibitors.
  • Having poorly controlled asthma, poorly controlled atopic dermatitis prior to study.
  • Inability to discontinue antihistamines or other medication for skin testing and oral challenges.
  • Unable to comply with the study protocol for any reason.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: June Chan, Master 2835-8430
Contact: Tak Hong Lee, Doctor 2835-8430
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02490813
Other Study ID Numbers  ICMJE ALC-002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hong Kong Sanatorium & Hospital
Study Sponsor  ICMJE Hong Kong Sanatorium & Hospital
Collaborators  ICMJE Chinese University of Hong Kong
Investigators  ICMJE
Principal Investigator: June Chan, Master Hong Kong Sanatorium & Hospital
PRS Account Hong Kong Sanatorium & Hospital
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP