Effectiveness of Qufeng Shengshi Fang on Treatment of Allergic Rhinitis.
1 other identifier
interventional
180
1 country
1
Brief Summary
This is a controlled clinical trials about traditional Chinese medicine named Qufeng Shengshi Fang，which consisted of cicada slough，bombyx batryticatus，radix angelicae，radix sileris，honeysuckle flower，forsythia，lithospermum and radix glycyrrhizae，and Loratadine on treatment of Allergic Rhinitis.There are 180 Patients with allergic rhinitis recruited from Department of Allergy and Traditional Chinese.To carry on statistical analysis of the result of the self and between-group cross-reference by two questionnaires filled before and after treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2015
CompletedFirst Posted
Study publicly available on registry
January 12, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedApril 22, 2016
January 1, 2016
1.7 years
December 19, 2015
April 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement clinical symptoms of Allergen Rhinitis
Clinical symptoms of Allergen Rhinitis including Rhinocnesmus (0: No symptom；1：Intermittent；2：Formication but supportable；3：Formication and insupportable)，Sneeze (0: No symptom；1：3-5 times everyday；2：6-10 times everyday；3：\>11 times everyday)，Rhinorrhea (0: No symptom；1：modicum；2：medium；3：mass)，Rhinobyon (0: No symptom；1：Conscious inspiratory；2：Intermittent；3：Mostly breathing through mouth)，Itchy eyes(0: No symptom；1：Pruritus but supportable；2：Need rub eyes occasionally；3：Need rub eyes frequently)，Racryorrhea (0: No symptom；1：With sneezing；2：between 1and 3；3：No sneeze also )，Itchy ears and palate(0: No symptom；1：Intermittent；2：Pruritus but supportable；3：Pruritus and insupportable). Assessing the change by comparing the symptom score before and after treatment.
0，4 and 8 weeks
Secondary Outcomes (12)
Liver Function Examination
0，4 and 8 weeks
Renal Function Examination
0，4 and 8 weeks
Secretory immunoglobulin E Examination
0 and 8 weeks
Blood Routine Examination
0，4 and 8 weeks
Urine Routine Examination
0，4 and 8 weeks
- +7 more secondary outcomes
Study Arms (2)
Qufeng Shengshi Fang and Loratadine
EXPERIMENTALQufeng Shengshi Fang is a traditional Chinese medicine form 8 kinds of herbs. Loratadine is the second generation antihistamines, after converted into its active metabolite Carrie period (carebastine), its antihistamines and allergy effect has been demonstrated in vitro and in vivo tests, also received data from clinical trials.
Loratadine
ACTIVE COMPARATORLoratadine (INN) is a second-generation H1 histamine antagonist drug used to treat allergies. In structure, it is closely related to tricyclic antidepressants, such as imipramine, and is distantly related to the atypical antipsychotic quetiapine.Loratadine is marketed by Schering-Plough\[needs update\] under several trade names (e.g., Claritin) and also by Shionogi in Japan. It is available as a generic drug and is marketed for its nonsedating properties. In a version named Claritin-D or Clarinase, it is combined with pseudoephedrine, a decongestant; this makes it useful for colds, as well as allergies but adds potential side effects of insomnia, anxiety, and nervousness.
Interventions
The patients with allergic rhinitis are divided into two groups, one is experimental group, and the other is control group. The experimental group patients are treated with Qufeng by oral, 200ml two times a day and Loratadine by oral,10mg QD
The patients with allergic rhinitis are divided into two groups, one is experimental group, and the other is control group. The control group patients are treated with Loratadine by oral, 10mg QD
Eligibility Criteria
You may qualify if:
- meet allergic rhinitis (include allergic rhinitis with asthma) diagnostic criteria at Peking Union Medical College Hospital Department of Allergy;
- have allergic rhinitis in episodes.
- without antihistamine,local anaesthetic or traditional Chinese medicine in last months.
- signed the informed consent form.
You may not qualify if:
- have severe deviation of nasal septum and nasal polyps.
- have nasal surgery or a history of cancer(tumor).
- have other serious illness or evidence of mental disorders.
- female in pregnancy and lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital traditional Chinese medicine department
Beijing, Beijing Municipality, 100730, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Xiaochun Liang, Doctor
Peking Union Medical College Hospital traditional Chinese medicine department
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2015
First Posted
January 12, 2016
Study Start
June 1, 2016
Primary Completion
March 1, 2018
Study Completion
August 1, 2018
Last Updated
April 22, 2016
Record last verified: 2016-01