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

Phase 3

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: Phlai; Drug: Placebo oral capsule

• Registration Number: NCT04182919
• Lead Sponsor: Chulalongkorn University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-26
• Study First Submitted QC: 2019-11-29
• Study First Posted: 2019-12-02
• Study Start: 2020-01-31
• Primary Completion: 2021-12-20
• Study Completion: 2021-12-20
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 267

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Phlai	Phlai 2 capsules (compound D 8 mg) od evening after meal x 4 weeks
Arm 3	Placebo oral capsule	Placebo 2 capsules od evening after meal x 4 weeks
Arm 2	Phlai	Phlai 1 capsules (compound D 4 mg) and placebo 1 capsule od evening after meal x 4 weeks
Arm 2	Placebo oral capsule	Phlai 1 capsules (compound D 4 mg) and placebo 1 capsule od evening after meal x 4 weeks

Primary Outcome Measures

Name	Time	Method
Total five symptoms score (T5SS)	24 hours	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

Secondary Outcome Measures

Name	Time	Method
AST Level	4 weeks	Liver function test
BUN	4 weeks	Renal function test
Eosinophils blood level	4 weeks	CBC test
Platelet level	4 weeks	CBC test
Rhinoconjunctivitis Quality of Life Questionaire (RCQ-36) Thai version	4 weeks	This questionnaire is designed to find out how your health and well-being have been affected by rhinoconjunctivitis.
Nasal examination	2 weeks	Outcome assessor in each site will check the three symptoms: nasal swelling, pale and nasal discharge by anterior rhinoscopy
Adverse events	2 weeks	Sedation, dizziness, dry mouth, headache
Creatinine level	4 weeks	Renal function test
Peak inspiratory nasal flow (PNIF)	2 weeks	Use to measure nasal airflow during maximal inspiration
ALT Level	4 weeks	Liver function test
Lymphocyte blood level	4 weeks	CBC test
Hemoglobin	4 weeks	CBC test

Trial Locations

Locations (1)

Minh Phuoc Hoang, MD; 🇹🇭 Bangkok, Thailand