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Effectiveness of Qufeng Shengshi Fang on Treatment of Allergic Rhinitis.

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02653339
Recruitment Status : Unknown
Verified January 2016 by Peking Union Medical College Hospital.
Recruitment status was:  Not yet recruiting
First Posted : January 12, 2016
Last Update Posted : April 22, 2016
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Perennial Drug: Qufeng Shengshi Fang and Loratadine Drug: Loratadine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Loratadine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Qufeng Shengshi Fang and Loratadine
Qufeng 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.
 Drug: Qufeng Shengshi Fang and Loratadine

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


Drug: Loratadine

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

Other Name: Claritin，WS1-(X-014)-2004Z
Active Comparator: Loratadine
Loratadine (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.
 Drug: Qufeng Shengshi Fang and Loratadine

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


Drug: Loratadine

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

Other Name: Claritin，WS1-(X-014)-2004Z


Outcome Measures
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Primary Outcome Measures :
  1. Improvement clinical symptoms of Allergen Rhinitis [ Time Frame: 0，4 and 8 weeks ]
    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.


Secondary Outcome Measures :
  1. Liver Function Examination [ Time Frame: 0，4 and 8 weeks ]
    Liver function examination including alanine aminotransferase (ALT) (U/L) , aspartate transaminase (AST) (U/L) and glutamyl transpeptidase （GGT）(U/L).

  2. Renal Function Examination [ Time Frame: 0，4 and 8 weeks ]
    Renal function examination including blood urea nitrogen(BUN)（mmol/L）and urine creatinine(UCr) (mmol/d).

  3. Secretory immunoglobulin E Examination [ Time Frame: 0 and 8 weeks ]
  4. Blood Routine Examination [ Time Frame: 0，4 and 8 weeks ]
    Blood Routine Examination including white blood cell(WBC)(*10^9/L),monocyte number（MONO#）(*10^9/L)，monocyte percentage (MONO%)(%)，lymphocyte number（LY#）(*10^9/L)，lymphocyte percentage (LY%)(%)，neutrophil number（NEUT#）(*10^9/L)，neutrophil percentage (NEUT%)(%)，eosinophil number（NEUT#）(*10^9/L)，eosinophil percentage (NEUT%)(%)，red blood cell(RBC)(*10^12/L),hemoglobin(HGB) (g/L) and platelet count(PLT)(*10^9/L).

  5. Urine Routine Examination [ Time Frame: 0，4 and 8 weeks ]
    Urine Routine Examination including occult blood(BLD)(Cells/μL) and proteinuria(PRO)(g/L).

  6. Fractional Exhaled Nitric Oxide Examination [ Time Frame: 0 and 8 weeks ]
  7. Test of Cytokine [ Time Frame: 8 weeks ]
    Cytokines is a kind of low-molecular-weight soluble protein, which has function of regulating inherent immunity and adaptive immunity, erythropoiesis, cell growth and injured tissue repair and others.In the study FlowCellect™ Mouse Th2 Intracellular Cytokine Kit (FCIM025124) and Th17 Intracellular Cytokine Kit (FCIM025125) will be used to compare the change on cytokine before and after treatment. This FlowCellect Mouse Cytokine Th2 Identification Kit for flow cytometry is designed to enable a researcher a quick & easy way to detect IL-4 expression in mouse Th2 CD4+ T-cells. This FlowCellect Mouse Cytokine Th17 Identification Kit for flow cytometry is designed to enable a researcher a quick & easy way to detect IL-17 expression in mouse Th17 CD4+ T-cells.

  8. Test of Metabonomics [ Time Frame: 8 weeks ]
    Metabolomics is the scientific study of chemical processes involving metabolites. Specifically, metabolomics is the "systematic study of the unique chemical fingerprints that specific cellular processes leave behind", the study of their small-molecule metabolite profiles. The metabolome represents the collection of all metabolites in a biological cell, tissue, organ or organism, which are the end products of cellular processes. Small molecules are the objects in Metabonomics which relative molecular mass is less than 1000.In the study NMR will be used as a way to assess the change on Metabonomics before and after treatment.

  9. Test of Proteomics [ Time Frame: 8 weeks ]
    The proteome is the entire set of proteins expressed by a genome, cell, tissue or organism at a certain time. More specifically, it is the set of expressed proteins in a given type of cell or organism, at a given time, under defined conditions. The term is a portmanteau of proteins and genome. Proteomics is the study of the proteome.In the study Mass Spectrometry will be used to compare the change on proteome before and after treatment.

  10. Change of Exosomes [ Time Frame: 8 weeks ]
    Exosomes as a utricle bubble structure are widely distributed in the peripheral blood, urine, saliva, ascites, amniotic fluid, and other body fluids. Exosomes carry different components, which are secreted by different cells, and these components give exosomes a variety in biological functions, such as potential biomarkers of immune cells, cancer, etc.In the study Ribo™ Exosome Isolation Reagent (for plasma or serum) will be used to compare the change on exosomes before and after treatment.

  11. IncRNA Sequencing [ Time Frame: 8 weeks ]
    Long non-coding RNAs (lnc RNAs) are non-protein coding RNA molecules with the sequence longer than 200 nucleotides. They are four times amount as protein coding transcripts and play important roles in diverse cellular regulations. Function identification of these lncRNAs remains challenging although abundant efforts were put in this field. In the study gene expression profile , named RiboArrayTM lncDETECTTM Human Array, will be used which are provided by RiboBio Co., Ltd.

  12. Pulmonary function Examination [ Time Frame: 8 weeks ]
    Pulmonary function Examination including forced expiratory volume in one second(FEV1)(L), forced vital capacity rate of one second(FEV1.0/FVC)(%), maximal mid-expiratory flow velocity(L/s), maximal expiratory flow in 50% vital capacity(L), maximal expiratory flow in 75% vital capacity(L) and peak expiratory flow rate(PEFR)(L/s).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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): NCT02653339


Contacts
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Contact: Xiaoyang Zhang, Doctor (+86)13910769068 zhangxymz@163.com

Locations
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China, Beijing
Peking Union Medical College Hospital traditional Chinese medicine department
Beijing, Beijing, China, 100730
Contact: Xiaoyang Zhang, Doctor    (+86)13910769068    zhangxymz@163.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Study Director: Xiaochun Liang, Doctor Peking Union Medical College Hospital traditional Chinese medicine department
More Information
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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02653339    
Other Study ID Numbers: JS-958
First Posted: January 12, 2016    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: January 2016
Keywords provided by Peking Union Medical College Hospital:
traditional Chinese medicine
Loratadine
questionnaire survey
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Loratadine
Antipruritics
Dermatologic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs