"Efficacy and Safety of Phlai Capsule Compared to Placebo as the Treatment in Allergic Rhinitis Patients"

"Efficacy and Safety of Phlai Capsule Compared to Placebo as the Treatment in Allergic Rhinitis Patients"

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.

Inclusion Criteria:

• Age 18-50 years old
• Allergic rhinitis following diagnostic criteria of ARIA guideline
• Reflective total 5 symptoms score 2-10 per day for 3 consecutive days (total score=15) and not greater than 10 in any days during the past week
• Positive skin prick test to at least one aeroallergen: wheal size ≥ 3 mm greater than negative control
• Not receiving intranasal corticosteroid + intra antihistamine for 2 weeks , intranasal corticosteroid for 2 weeks, systemic corticosteroid for 4 weeks, antihistamine for 1 week, nasal decongestant for 1 week and leukotriene receptor antagonists for 1 week

Exclusion Criteria:

• Serious medical underlying diseases e.g. COPD, Heart disease, Chronic renal failure, chronic hepatic failure
• Allergic rhinitis and asthma which require immunotherapy
• Receiving antidepressants, sedative, anxiolytic, opioids, neuroleptic
• Uncontrolled asthma which requires steroid inhaler, LABA and does not use leukotriene receptor antagonists
• Previous nasal surgery for nasal polyp, nasal septum deviation
• Acute or chronic rhinosinusitis
• Pregnancy and lactation (Urine pregnancy test is allowed and paid by researchers)
• Allergic to any kinds of herb
• Refusal to participation