Clinical TrialID 385

Safety and Efficacy of Sublingual Immunotherapy for Allergic Rhinitis Due to Artemisia Annua

NCT03990272

Allergic Rhinitis

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Record Fields

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Clinical Trial Id
385
Evidence Id
385
Core Evidence Id
385
Source Clinical Trial Id
371
Herb2 Clinical Trial Id
HBCT000371
Nct Id
NCT03990272
Title
Safety and Efficacy of Sublingual Immunotherapy for Allergic Rhinitis Due to Artemisia Annua
Status
Completed
Phase
Phase 3
Study Result
No
Study Condition
Allergic Rhinitis
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Intervention
DRUG: AIT drops|DRUG: placebo drops
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Double
Intervention Purpose
Treatment
Gender
All
Age
Adult
Enrollment
702
Outcome Measure
daily combined scores of medication and rhinoconjunctivitis symptoms (CSMRS), the daily combined scores of medication and rhinoconjunctivitis symptoms (CSMRS) (ranging from 0 to 6); which was calculated as the combined score of daily average scores of 6 rhinoconjunctivitis symptoms (rhinorrhea, nasal congestion, nasal itching, sneezing, ocular pruritus, and watery eyes) and the daily rescue medication score, at the peak pollen season(The start was defined as the first of 3 consecutive days with a pollen count of 50 pollen/m3 or greater each day. The end was defined as the last occurrence of 3 consecutive days with ≥50 pollen/m3 each day)
Sponsor Collaborator
Beijing Tongren Hospital|Zhejiang Wolwo Bio-Pharmaceutical Co., Ltd.
Funded By
OTHER
Location
Beijing Shijitan Hospital, Beijing, China|Beijing Tongren Hospital, Beijing, China|Peking University People's Hospital, Beijing, China|West China Hospital, Sichuan University, Chendu, China|Qingdao Municipal Hospital, Qingdao, China|No. 202 Hospital of PLA (General Hospital of Northern Theater Command ), Shenyang, China|First Hospital of Shanxi Medical University, Taiyuan, China|Second Hospital of Shanxi Medical University, Taiyuan, China|Tianjin Medical University General Hospital, Tianjin, China|Shaanxi Provincial People's Hospital, Xi'an, China|The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China|General Hospital of Ningxia Medical University, Yinchuan, China|The First Affiliated Hospital of Xinjiang Medical University, Ürümqi, China
Other Id
TR-SLIT-AA-MC
Start Date
2017-03-20
Primary Completion Date
2017-10-22
Completion Date
2017-10-30
First Posted
2019-06-18
Results First Posted
Last Update Posted
2020-07-16
Study Document
Study Url
https://clinicaltrials.gov/study/NCT03990272
Title Cn
Title En
Safety and Efficacy of Sublingual Immunotherapy for Allergic Rhinitis Due to Artemisia Annua
Bilingual Status
semi_complete