Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-01 @ 10:28 AM
Study NCT ID:
NCT04234451
Status:
UNKNOWN
Last Update Posted:
2021-07-26
First Post:
2020-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy, Safety and Underlying Mechanisms of Sphenopalatine Ganglion Acupuncture for Perennial Allergic Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012221', 'term': 'Rhinitis, Allergic, Perennial'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-22', 'studyFirstSubmitDate': '2020-01-16', 'studyFirstSubmitQcDate': '2020-01-16', 'lastUpdatePostDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline symptom scores at visit 4', 'timeFrame': 'Symptom scores will be assessed at baseline (V0), visit 4( V4). V4 is at the second week 15 minutes after the fourth acupuncture.', 'description': 'Patients recorded nasal and ocular symptom severity during the trial. Four nasal symptoms (itching, sneezing, rhinorrhoea and nasal obstruction) and two ocular symptoms (ocular itch and watery eyes) were individually graded on a ten-point scale (0, no symptoms; 1-3, mild symptoms; 4-7, moderate symptoms; 8-10, severe symptoms). Our primary outcome is total nasal symptom scores at Visit 4 (15 minutes after the fourth acupuncture ). The investigator will compare the symptom scores between the active acupuncture group and the sham acupuncture group.'}], 'secondaryOutcomes': [{'measure': 'Rescue medication score', 'timeFrame': 'RMS will be assessed at baseline (V0), and each visit. V1, V2, V3, and V4 is on Day 1, Day 4, Day 8 and Day 11, respectively(+/- 1 day). V5 is at the third week and V6 is at the fourth week. There is no acupuncture during both V5 and V6.', 'description': 'when the symptoms were very severe and could not be tolerated, the patients could use loratadine as rescue medication. The need for rescue medication was assessed as rescue medication score (RMS), analyzed as the weekly sum of daily use of Loratadine (10mg/d, equivalent to 1 point) or nasal corticosteroid spray (2 points)'}, {'measure': 'rhinoconjunctivitis quality of life questionnaire (RQLQ)', 'timeFrame': 'RQLQ will be assessed at baseline (V0), and each visit. V1, V2, V3, and V4 is on Day 1, Day 4, Day 8 and Day 11, respectively(+/- 1 day). V5 is at the third week and V6 is at the fourth week. There is no acupuncture during both V5 and V6.', 'description': 'RQLQ is assessed to evaluate the quality of life influenced by PAR. It offers 28 items related quality of life and each item ranges from 0 to 6, with lower scores implying a better health-related quality of life.'}, {'measure': 'nasal patency', 'timeFrame': 'NCV, NAR and MCA will be assessed at baseline (V0), and each visit. V1, V2, V3, and V4 is on Day 1, Day 4, Day 8 and Day 11, respectively(+/- 1 day). V5 is at the third week, and V6 at the fourth week.', 'description': 'Eccovision acoustic rhinometry (Hood Labs, Pembroke, USA) was used to measure the total nasal cavity volume (NCV) and minimum cross-sectional area (MCA). The ATMO 300 Rhinomanometer (ATMOS MedizinTechnikGmbH\\&Co., Feldkirch, Germany) was used to measure the nasal airway resistance (NAR) by anterior active rhinomanometry.'}, {'measure': 'neuropeptides in nasal secretions', 'timeFrame': 'Nasal secretions can be obtained at baseline (V0), V4,V5 and V6. V4 is at the second week. V5 is at the third week and V6 is at the fourth week. There is no acupuncture during both V5 and V6.', 'description': 'The levels of neuropeptides; including substance P, vasoactive intestinal peptide (VIP) , neuropeptide Y (NPY)) will be analysed using ELISA. The unit of all these parameters is ng/ml.'}, {'measure': 'inflammatory cytokines in nasal secretions', 'timeFrame': 'Nasal secretions can be obtained at baseline (V0), V4 ,V5 and V6. V4 is at the second week. V5 is at the third week and V6 is at the fourth week. There is no acupuncture during both V5 and V6.', 'description': 'The levels of inflammatory cytokines; including interferon-γ (IFN-γ), tumor necrosis factor-α(TNF-α), interleukin (IL)-5, IL-8, IL-17A, and eotaxin in the supernatants will be analyzed using the Luminex System. The unit of all these parameters is pg/ml.'}, {'measure': 'adverse events', 'timeFrame': 'adverse events will be recorded at baseline (V0), and each visit. V1, V2, V3, and V4 is on Day 1, Day 4, Day 8 and Day 11, respectively(+/- 1 day). V5 is at the third week and V6 is at the fourth week. There is no acupuncture during both V5 and V6.', 'description': 'Any adverse event following acupuncture was assessed by physicians and patients. Patients were instructed to record any unexpected signs, symptoms, and feelings during the entire trial period.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acupuncture', 'sphenopalatine ganglion', 'perennial allergic rhinitis', 'neuropeptides', 'inflammatory cytokines', 'neuro-immune interactions'], 'conditions': ['Perennial Allergic Rhinitis']}, 'referencesModule': {'references': [{'pmid': '23253122', 'type': 'BACKGROUND', 'citation': 'Choi SM, Park JE, Li SS, Jung H, Zi M, Kim TH, Jung S, Kim A, Shin M, Sul JU, Hong Z, Jiping Z, Lee S, Liyun H, Kang K, Baoyan L. A multicenter, randomized, controlled trial testing the effects of acupuncture on allergic rhinitis. Allergy. 2013 Mar;68(3):365-74. doi: 10.1111/all.12053. Epub 2012 Dec 18.'}, {'pmid': '26073163', 'type': 'BACKGROUND', 'citation': 'Xue CC, Zhang AL, Zhang CS, DaCosta C, Story DF, Thien FC. Acupuncture for seasonal allergic rhinitis: a randomized controlled trial. Ann Allergy Asthma Immunol. 2015 Oct;115(4):317-324.e1. doi: 10.1016/j.anai.2015.05.017. Epub 2015 Jun 11.'}, {'pmid': '27425415', 'type': 'BACKGROUND', 'citation': 'Wang K, Chen L, Wang Y, Wang C, Zhang L. Sphenopalatine Ganglion Acupuncture Improves Nasal Ventilation and Modulates Autonomic Nervous Activity in Healthy Volunteers: A Randomized Controlled Study. Sci Rep. 2016 Jul 18;6:29947. doi: 10.1038/srep29947.'}, {'pmid': '23420231', 'type': 'BACKGROUND', 'citation': 'Brinkhaus B, Ortiz M, Witt CM, Roll S, Linde K, Pfab F, Niggemann B, Hummelsberger J, Treszl A, Ring J, Zuberbier T, Wegscheider K, Willich SN. Acupuncture in patients with seasonal allergic rhinitis: a randomized trial. Ann Intern Med. 2013 Feb 19;158(4):225-34. doi: 10.7326/0003-4819-158-4-201302190-00002.'}]}, 'descriptionModule': {'briefSummary': 'In recent years, a number of randomized controlled trials have confirmed the efficacy and safety of acupuncture in the treatment of allergic rhinitis (AR). Indeed, the latest American clinical guidelines recommended acupuncture treatment for AR patients who are interested in non-pharmacological treatment.\n\nIn conventional acupuncture treatment for AR, needles are inserted at specific acupoints in the body; with several studies demonstrating acupuncture of sphenopalatine ganglion (SPG) to improve nasal symptoms and quality of life in nasal inflammatory diseases.\n\nThe investigators hypothesize that, compared with sham acupuncture and rescue medication (RM), active SPG acupuncture combined with RM would lead to greater improvements in symptoms score and reduction in overall need for antihistamines. To test this hypothesis the investigators design a randomized, double blind, controlled trial to evaluate the efficacy of SPG acupuncture in perennial AR patients (allergic to indoor allergens, including house dust mite, fungi, animal dander and so one) and to explore the potential underlying mechanisms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. history of physician-diagnosed PAR with at least 2 years of typical symptoms\n* 2\\. course on each onset lasting at least 4 weeks\n* 3\\. skin prick test and/or serum antigen specific IgE positive to indoor allergens(sIgE≥0.7kU/L,≥class 2)\n* 4\\. good patient compliance on acupuncture treatment\n* 5\\. total nasal symptom scores(TNSS)\\>6 at V0\n\nExclusion Criteria:\n\n* 1\\. oral steroids within 4 weeks prior to recruitment\n* 2\\. nasal steroids and/or antihistamine 2 weeks prior to recruitment\n* 3\\. seasonal AR\n* 4\\. any respiratory infection within the previous 4 weeks prior to recruitment\n* 5\\. history of nasal polyps, nasal septum deviation, asthma or autoimmune disorders\n* 6\\. previously received acupuncture therapy for AR within 1 month prior to recruitment\n* 7\\. women during pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT04234451', 'briefTitle': 'Efficacy, Safety and Underlying Mechanisms of Sphenopalatine Ganglion Acupuncture for Perennial Allergic Rhinitis', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tongren Hospital'}, 'officialTitle': 'Efficacy, Safety and Underlying Mechanisms of Sphenopalatine Ganglion Acupuncture for Perennial Allergic Rhinitis: a Randomized, Double-blind, Placebo Controlled Study', 'orgStudyIdInfo': {'id': 'SPA acupuncture for PAR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SPA acupuncture', 'description': 'active SPG acupuncture plus rescue medication (AA group)', 'interventionNames': ['Procedure: SPA acupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham acupuncture', 'description': 'sham-SPG acupuncture plus rescue medication (SA group)', 'interventionNames': ['Procedure: sham acupuncture']}], 'interventions': [{'name': 'SPA acupuncture', 'type': 'PROCEDURE', 'description': 'For patients in the AA group, acupuncture was performed at a selected point in the SPG by inserting the needle from the lower border of the zygomatic arch, posterior to the suture protuberance between the zygomatic process and temporal process. The needle was directed obliquely anteriorly, until nearly the whole needle was beneath the skin, and then rotated until the patient felt "de-qi" sensations . The patients in the AA group received four courses of active acupuncture(visit 1,2,3 and 4), twice a week during weeks 1 and 2, and then followed-up for a further 2 weeks (visit 5 during week 3 and visit 6 during week 4).', 'armGroupLabels': ['SPA acupuncture']}, {'name': 'sham acupuncture', 'type': 'PROCEDURE', 'description': "For patients in the SA group, the needle was inserted at the same acupuncture point as for patients in the AA group, but to a depth of only 2-3cm and the procedure of rotating, twirling and thrusting the needle was repeated. During the acupuncture process, the acupuncturist sat on the side of the participant, where the patient could neither see the acupuncturist's face nor the length of the needle. The patients in the SA group received four courses of active acupuncture(visit 1,2,3 and 4), twice a week during weeks 1 and 2, and then followed-up for a further 2 weeks (visit 5 during week 3 and visit 6 during week 4).", 'armGroupLabels': ['sham acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Hongfei Lou, Doctor', 'role': 'CONTACT'}], 'facility': 'Beijing Tongren Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Hongfei Lou', 'role': 'CONTACT', 'email': 'louhongfei@yahoo.com', 'phone': '(8610)58268375'}, {'name': 'Chengshuo Wang', 'role': 'CONTACT', 'email': 'wangcs830@126.com', 'phone': '(8610)58265801'}], 'overallOfficials': [{'name': 'Luo Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tongren Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tongren Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}