Effectivness and Safety of Acupuncture Combined With Moxibustion for Allergic Rhinitis

NCT02339714 | Completed Phase 2 DMC

• 1 other identifier: AAMH001
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 3

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.

Conditions

Rhinitis, Allergic, Perennial

Keywords

allergic rhinitis; acupuncture; moxibustion; efficacy; safety

Outcome Measures

Primary Outcomes (1)

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

  at the 4th week

Secondary Outcomes (2)

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

  at the 4th week

• Change from baseline in Quality of life questionnaire (QLQ) at the 4th week

  at the 4th Week

Study Arms (2)

Acupuncture combined moxibustion

EXPERIMENTAL

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.

Other: acupuncture combined moxibustion

loratadine

ACTIVE COMPARATOR

Loratadine taken orally, 10mg/day in the morning

Drug: Loratadine

Interventions

acupuncture combined moxibustion OTHER

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.

Also known as: warming needle

Acupuncture combined moxibustion

Loratadine DRUG

Loratadine will be taken orally at the dose of 10mg/day in the morning. Each treatment cycle will be given for continuous 4 weeks.

loratadine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhao Hong: lead
• China Academy of Chinese Medical Sciences: collaborator
• Beijing Municipal Science & Technology Commission: collaborator

Study Sites (3)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

Location

Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100700, China

Location

Mentougou Hospital of TCM

Beijing, Beijing Municipality, 102300, China

Location

Related Publications (1)

• 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.

  PMID: 27363578 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial; Rhinitis, Allergic

Interventions

Loratadine

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Liu Baoyan, Master

  Vice President of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice president of acupuncture and moxibustion hospital

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: January 15, 2015
• Study Start: March 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2018
• Last Updated: July 18, 2018

Record last verified: 2018-07

Locations

CN (3)