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

Study Overview
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Brief Summary
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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.

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

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: Phlai
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participant in each arm will take medication provided by care providers who also do not know what kind of this medication
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>Phlai 2 capsules (compound D 8 mg) od evening after meal x 4 weeks | Drug: Phlai<br>* Each capsule contains 4 mg compound D. Using orally in the evening everyday in 4 weeks<br>* Other names: Zingiber cassumunar;|
| Experimental: Arm 2<br>Phlai 1 capsules (compound D 4 mg) and placebo 1 capsule od evening after meal x 4 weeks | Drug: Phlai<br>* Each capsule contains 4 mg compound D. Using orally in the evening everyday in 4 weeks<br>* Other names: Zingiber cassumunar;Drug: Placebo oral capsule<br>* 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<br>|
| Placebo Comparator: Arm 3<br>Placebo 2 capsules od evening after meal x 4 weeks | Drug: Placebo oral capsule<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total five symptoms score (T5SS) | T5SS: (nasal obstruction, rhinorrhea, sneezing, itchy nose, itchy eyes). For each symptom: 0: no symptoms mild moderate 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 | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 weeks | 
| Peak inspiratory nasal flow (PNIF) | Use to measure nasal airflow during maximal inspiration | 2 weeks | 
| Nasal examination | Outcome assessor in each site will check the three symptoms: nasal swelling, pale and nasal discharge by anterior rhinoscopy | 2 weeks | 
| Adverse events | Sedation, dizziness, dry mouth, headache | 2 weeks | 
| AST Level | Liver function test | 4 weeks | 
| ALT Level | Liver function test | 4 weeks | 
| Creatinine level | Renal function test | 4 weeks | 
| BUN | Renal function test | 4 weeks | 
| Eosinophils blood level | CBC test | 4 weeks | 
| Lymphocyte blood level | CBC test | 4 weeks | 
| Hemoglobin | CBC test | 4 weeks | 
| Platelet level | CBC test | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Zingiber cassumunar, Phlai, compound D, herbal medicine, allergic rhinitis