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Effectivness and Safety of Acupuncture Combined With Moxibustion for Allergic Rhinitis

Primary Purpose

Rhinitis, Allergic, Perennial

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
acupuncture combined moxibustion
Loratadine
Sponsored by
Zhao Hong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Perennial focused on measuring allergic rhinitis, acupuncture, moxibustion, efficacy, safety

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Each participant must have a diagnosis of AR by an otolaryngology doctor, according to the criteria listed in "Allergic Rhinitis and its Impact on Asthma" (ARIA 2008) Symptoms that had persisted for more than 4 days per week for more than four consecutive weeks.

At least one of the following rhinitis-associated conditions: nasal obstruction, rhinorrhea, sneezing and nasal itching.

At least one positive result on an allergy skin prick reaction test at screening.

-

Exclusion Criteria:

Active tuberculosis Autoimmune disorders Severe chronic inflammatory diseases History of anaphylactic reactions Specific immunotherapy >3 years Simultaneous participation in other clinical trials Serious acute or chronic organic disease or mental disorder Congenital nasal abnormalities Pregnancy or breast feeding Blood coagulation disorder and/or current use of anticoagulants Allergy desensitisation therapy (current, during the past two years, or planned in the next two years) Previous systemically administered corticosteroids, antihistamines, or decongestants in the last 1 months prior to enrollment

-

Sites / Locations

  • Guang'anmen Hospital, China Academy of Chinese Medical Sciences
  • Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences
  • Mentougou Hospital of TCM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acupuncture combined moxibustion

loratadine

Arm Description

Acupuncture at Hegu(LI4),Yingxiang(LI20),Chize(LU5),Sibai(ST2), Yintang(EX-HN3),Shangyingxiang(EX-HN8),Shangxing(GV23),Dazhui(Du14). Needle warming moxibustion at Dazhui(Du14). Patients will be treated once per day for 30 min, 3 times in a weeks for 4 weeks.

Loratadine taken orally, 10mg/day in the morning

Outcomes

Primary Outcome Measures

Change from baseline in the weekly average of the participants' total nasal symptom score (TNSS) at the 4th week.

Secondary Outcome Measures

Change from baseline in the weekly average of the participants' total non-nasal symptom score (TNNSS) at the 4th week
Change from baseline in Quality of life questionnaire (QLQ) at the 4th week

Full Information

First Posted
January 13, 2015
Last Updated
July 17, 2018
Sponsor
Zhao Hong
Collaborators
China Academy of Chinese Medical Sciences, Beijing Municipal Science & Technology Commission
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1. Study Identification

Unique Protocol Identification Number
NCT02339714
Brief Title
Effectivness and Safety of Acupuncture Combined With Moxibustion for Allergic Rhinitis
Official Title
Effect Comparison of Acupuncture Combined With Moxibustion and Loratadine for Perennial Allergic Rhinitis: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhao Hong
Collaborators
China Academy of Chinese Medical Sciences, Beijing Municipal Science & Technology Commission

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A multi-centre clinical trial done by us（ISRCEN90807007）showed that active acupuncture had significantly greater effect on symptoms of allergic rhinitis than either sham acupuncture or no active treatment. The object of that study was to evaluate the effectiveness and safety of acupuncture for allergic rhinitis. As an explanatory research, acupuncture was defined as the only intervention for treatment group and sham acupuncture, no active treatment as its control groups. Besides, acupuncture combined moxibustion showed better and longer effect than acupuncture on allergic rhinitis patients in our previous pilot study. According to this result, we are taking a pragmatic randomized controlled trial to further evaluate whether acupuncture combined moxibustion is more effective than conventional treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Perennial
Keywords
allergic rhinitis, acupuncture, moxibustion, efficacy, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture combined moxibustion
Arm Type
Experimental
Arm Description
Acupuncture at Hegu(LI4),Yingxiang(LI20),Chize(LU5),Sibai(ST2), Yintang(EX-HN3),Shangyingxiang(EX-HN8),Shangxing(GV23),Dazhui(Du14). Needle warming moxibustion at Dazhui(Du14). Patients will be treated once per day for 30 min, 3 times in a weeks for 4 weeks.
Arm Title
loratadine
Arm Type
Active Comparator
Arm Description
Loratadine taken orally, 10mg/day in the morning
Intervention Type
Other
Intervention Name(s)
acupuncture combined moxibustion
Other Intervention Name(s)
warming needle
Intervention Description
Points: Hegu(LI4),Yingxiang(LI20),Chize(LU5),Sibai(ST2), Yintang(EX-HN3),Shangyingxiang(EX-HN8),Shangxing(GV23),Dazhui(Du14). Pierced the skin, needles are inserted 0.5 to 2cm into the acupoints. Each needle are roated until the participants and the practitioner felt de-qi sensation. After that, moxibustion is applied to Dazhui(Du14). A 1cm long moxa cone is putted on the top of the needle at the acupoint, then ignite moxa cone until the cone is burn. The needles are left in place for 30 minutes. once every two days, 3 times in a week for consecutive 4 weeks, 12 times altogether.
Intervention Type
Drug
Intervention Name(s)
Loratadine
Intervention Description
Loratadine will be taken orally at the dose of 10mg/day in the morning. Each treatment cycle will be given for continuous 4 weeks.
Primary Outcome Measure Information:
Title
Change from baseline in the weekly average of the participants' total nasal symptom score (TNSS) at the 4th week.
Time Frame
at the 4th week
Secondary Outcome Measure Information:
Title
Change from baseline in the weekly average of the participants' total non-nasal symptom score (TNNSS) at the 4th week
Time Frame
at the 4th week
Title
Change from baseline in Quality of life questionnaire (QLQ) at the 4th week
Time Frame
at the 4th Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Each participant must have a diagnosis of AR by an otolaryngology doctor, according to the criteria listed in "Allergic Rhinitis and its Impact on Asthma" (ARIA 2008) Symptoms that had persisted for more than 4 days per week for more than four consecutive weeks. At least one of the following rhinitis-associated conditions: nasal obstruction, rhinorrhea, sneezing and nasal itching. At least one positive result on an allergy skin prick reaction test at screening. - Exclusion Criteria: Active tuberculosis Autoimmune disorders Severe chronic inflammatory diseases History of anaphylactic reactions Specific immunotherapy >3 years Simultaneous participation in other clinical trials Serious acute or chronic organic disease or mental disorder Congenital nasal abnormalities Pregnancy or breast feeding Blood coagulation disorder and/or current use of anticoagulants Allergy desensitisation therapy (current, during the past two years, or planned in the next two years) Previous systemically administered corticosteroids, antihistamines, or decongestants in the last 1 months prior to enrollment -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu Baoyan, Master
Organizational Affiliation
Vice President of China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100700
Country
China
Facility Name
Mentougou Hospital of TCM
City
Beijing
State/Province
Beijing
ZIP/Postal Code
102300
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
27363578
Citation
Sun Y, Zhao H, Ye Y, Nie W, Bai W, Liu J, Li S, Wang F, Han M, He L. Efficacy and safety of using a warming needle for persistent allergic rhinitis: study protocol for a randomized controlled trial. Trials. 2016 Jun 30;17(1):305. doi: 10.1186/s13063-016-1432-z.
Results Reference
derived

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Effectivness and Safety of Acupuncture Combined With Moxibustion for Allergic Rhinitis

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