"Efficacy and Safety of Phlai Capsule Compared to Placebo as the Treatment in Allergic Rhinitis Patients"
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
Background: Zingiber cassumunar Roxb., frequently known as Phlai in Thai, has been safely
used as an antihistaminic and anti-inflammatory drug in Thai traditional medicine. Individual
with allergic rhinitis may have positive response to Phlai.
Objective: Investigators assessed the efficacy and safety of Phlai as a treatment for
allergic rhinitis Design: The study was a 1-month, double-blind, randomized, parallel-group,
intent-to-treat, multicenter, controlled trial in 267 patients at 7 hospitals in Thailand.
Skin prick test-positive adults with allergic rhinitis ages 18 to 50 who were randomized into
3 groups (Phlai 8mg/d, Phlai 4mg/d, placebo).
Main outcome measures: Primary outcome was defined: improvement of total 5 symptoms scores
(nasal obstruction, rhinorrhea, sneezing, itchy nose, itchy eyes) over a 4-week interval
among Phlai 8mg/d, Phlai 4mg/d and placebo. Secondary endpoints were: assessments of
rhinoconjunctivitis quality of life questionnaire, peak inspiratory nasal flow, nasal
examination, adverse events, AST, ALT, Creatinine and BUN over a period of 4 weeks.