Pilot Study on Traditional Chinese Medicine and Food Allergy (TCMFA)
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|ClinicalTrials.gov Identifier: NCT02490813|
Recruitment Status : Recruiting
First Posted : July 7, 2015
Last Update Posted : February 22, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Allergy to Fish Allergy to Shrimp Allergy to Crab||Dietary Supplement: Treatment - Chinese Herbal Formula - X Dietary Supplement: Placebo||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Pilot Study on Traditional Chinese Medicine and Food Allergy|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Placebo Comparator: Control
This arm will receive the placebo.
Dietary Supplement: Placebo
Placebo will be starch with colorings
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.
Dietary Supplement: Treatment - Chinese Herbal Formula - X
Wu Mei (Fructus Pruni Mume), Ling Zhi (Gonoderma), Huang Bai (Cortex Phellodendron), and Zhi Su (Perilla frutescens).
- Tolerance to existing allergen [ Time Frame: 8 weeks ]subjects will be accessed on tolerance to existing allergen via opened oral food challenge
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02490813
|Contact: June Chan, Masteremail@example.com|
|Contact: Tak Hong Lee, Doctorfirstname.lastname@example.org|
|Principal Investigator:||June Chan, Master||Hong Kong Sanatorium & Hospital|