"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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: Phlai; Drug: Placebo oral capsule

• Study Type: Interventional
• Enrollment (Actual): 267
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Minh Phuoc Hoang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Collaborators: Government Pharmaceutical Organization

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2020
• Primary Completion (Actual): December 20, 2021
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: November 29, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: allergic rhinitis; herbal medicine; Zingiber cassumunar; Phlai; compound D
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: COA-CREC036/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Will plan to share information when finishing study
• IPD Sharing Time Frame: Plan to complete study in 2 years and will share the data after get publication
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No