Clinical trial NCT04182919: "Efficacy and Safety of Phlai Capsule Compared to Placebo as the Treatment in Allergic Rhinitis Patients"
Official title: "Efficacy and Safety of Phlai Capsule Compared to Placebo as the Treatment in Allergic Rhinitis Patients"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Rhinitis
Keywords: Zingiber cassumunar
Phlai
compound D
herbal medicine
allergic rhinitis
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Government Pharmaceutical Organization
First posted: 2019-12-02
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participant in each arm will take medication provided by care providers who also do not know what kind of this medication
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Total five symptoms score (T5SS)
timeFrame: 24 hours
Secondary outcomes:
measure: Rhinoconjunctivitis Quality of Life Questionaire (RCQ-36) Thai version
timeFrame: 4 weeks
measure: Peak inspiratory nasal flow (PNIF)
timeFrame: 2 weeks
measure: Nasal examination
timeFrame: 2 weeks
measure: Adverse events
timeFrame: 2 weeks
measure: AST Level
timeFrame: 4 weeks
measure: ALT Level
timeFrame: 4 weeks
measure: Creatinine level
timeFrame: 4 weeks
measure: BUN
timeFrame: 4 weeks
measure: Eosinophils blood level
timeFrame: 4 weeks
measure: Lymphocyte blood level
timeFrame: 4 weeks
measure: Hemoglobin
timeFrame: 4 weeks
measure: Platelet level
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Minh Phuoc Hoang, MD
Study officials:
References: