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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
267
Each capsule contains 4 mg compound D. Using orally in the evening everyday in 4 weeks
Like Phlai capsule extract : :PVP K30, Calcium carbonate, Dibasic calcium phosphate, Sodium starch glycolate, Colloidal silicon dioxide, Ethanol 96%, Purified water, Magnesium stearate. Not having compound D. Using orally in the evening everyday in 4 weeks
Minh Phuoc Hoang, MD
Bangkok, Thailand
Total five symptoms score (T5SS)
T5SS: (nasal obstruction, rhinorrhea, sneezing, itchy nose, itchy eyes). For each symptom: 0: no symptoms 1. mild 2. moderate 3. severe. Participants assess T5SS everyday. Self assessment twice a day Bedtime : reflective symptoms score Morning :instantaneous symptoms score. The mean score of two assessment is the T5SS. Investigator will calculate the mean T5SS in the follow up
Time frame: 24 hours
Rhinoconjunctivitis Quality of Life Questionaire (RCQ-36) Thai version
This questionnaire is designed to find out how your health and well-being have been affected by rhinoconjunctivitis.
Time frame: 4 weeks
Peak inspiratory nasal flow (PNIF)
Use to measure nasal airflow during maximal inspiration
Time frame: 2 weeks
Nasal examination
Outcome assessor in each site will check the three symptoms: nasal swelling, pale and nasal discharge by anterior rhinoscopy
Time frame: 2 weeks
Adverse events
Sedation, dizziness, dry mouth, headache
Time frame: 2 weeks
AST Level
Liver function test
Time frame: 4 weeks
ALT Level
Liver function test
Time frame: 4 weeks
Creatinine level
Renal function test
Time frame: 4 weeks
BUN
Renal function test
Time frame: 4 weeks
Eosinophils blood level
CBC test
Time frame: 4 weeks
Lymphocyte blood level
CBC test
Time frame: 4 weeks
Hemoglobin
CBC test
Time frame: 4 weeks
Platelet level
CBC test
Time frame: 4 weeks
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