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Effectiveness of Qufeng Shengshi Fang on Treatment of Allergic Rhinitis.

Primary Purpose

Rhinitis, Allergic, Perennial

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Qufeng Shengshi Fang and Loratadine
Loratadine
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Perennial focused on measuring traditional Chinese medicine, Loratadine, questionnaire survey

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Peking Union Medical College Hospital traditional Chinese medicine department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Qufeng Shengshi Fang and Loratadine

Loratadine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Liver Function Examination
Liver function examination including alanine aminotransferase (ALT) (U/L) , aspartate transaminase (AST) (U/L) and glutamyl transpeptidase (GGT)(U/L).
Renal Function Examination
Renal function examination including blood urea nitrogen(BUN)(mmol/L)and urine creatinine(UCr) (mmol/d).
Secretory immunoglobulin E Examination
Blood Routine Examination
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).
Urine Routine Examination
Urine Routine Examination including occult blood(BLD)(Cells/μL) and proteinuria(PRO)(g/L).
Fractional Exhaled Nitric Oxide Examination
Test of Cytokine
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.
Test of Metabonomics
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.
Test of Proteomics
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.
Change of Exosomes
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.
IncRNA Sequencing
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.
Pulmonary function Examination
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).

Full Information

First Posted
December 19, 2015
Last Updated
April 21, 2016
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02653339
Brief Title
Effectiveness of Qufeng Shengshi Fang on Treatment of Allergic Rhinitis.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Perennial
Keywords
traditional Chinese medicine, Loratadine, questionnaire survey

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Qufeng Shengshi Fang and Loratadine
Arm Type
Experimental
Arm Description
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.
Arm Title
Loratadine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Qufeng Shengshi Fang and Loratadine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Loratadine
Other Intervention Name(s)
Claritin,WS1-(X-014)-2004Z
Intervention Description
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
Primary Outcome Measure Information:
Title
Improvement clinical symptoms of Allergen Rhinitis
Description
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.
Time Frame
0,4 and 8 weeks
Secondary Outcome Measure Information:
Title
Liver Function Examination
Description
Liver function examination including alanine aminotransferase (ALT) (U/L) , aspartate transaminase (AST) (U/L) and glutamyl transpeptidase (GGT)(U/L).
Time Frame
0,4 and 8 weeks
Title
Renal Function Examination
Description
Renal function examination including blood urea nitrogen(BUN)(mmol/L)and urine creatinine(UCr) (mmol/d).
Time Frame
0,4 and 8 weeks
Title
Secretory immunoglobulin E Examination
Time Frame
0 and 8 weeks
Title
Blood Routine Examination
Description
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).
Time Frame
0,4 and 8 weeks
Title
Urine Routine Examination
Description
Urine Routine Examination including occult blood(BLD)(Cells/μL) and proteinuria(PRO)(g/L).
Time Frame
0,4 and 8 weeks
Title
Fractional Exhaled Nitric Oxide Examination
Time Frame
0 and 8 weeks
Title
Test of Cytokine
Description
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.
Time Frame
8 weeks
Title
Test of Metabonomics
Description
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.
Time Frame
8 weeks
Title
Test of Proteomics
Description
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.
Time Frame
8 weeks
Title
Change of Exosomes
Description
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.
Time Frame
8 weeks
Title
IncRNA Sequencing
Description
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.
Time Frame
8 weeks
Title
Pulmonary function Examination
Description
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).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoyang Zhang, Doctor
Phone
(+86)13910769068
Email
zhangxymz@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaochun Liang, Doctor
Organizational Affiliation
Peking Union Medical College Hospital traditional Chinese medicine department
Official's Role
Study Director
Facility Information:
Facility Name
Peking Union Medical College Hospital traditional Chinese medicine department
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoyang Zhang, Doctor
Phone
(+86)13910769068
Email
zhangxymz@163.com

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Qufeng Shengshi Fang on Treatment of Allergic Rhinitis.

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