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

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04182919
• Other study ID #: COA-CREC036/2019
• Status: Completed
• Phase: Phase 3
• Start date: January 31, 2020
• Est. completion date: December 20, 2021

Study information

• Verified date: January 2022
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: December 20, 2021
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Phlai
Each capsule contains 4 mg compound D. Using orally in the evening everyday in 4 weeks
• 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

Locations

Country	Name	City	State
Thailand	Minh Phuoc Hoang, MD	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Chulalongkorn University	Government Pharmaceutical Organization

Country where clinical trial is conducted

Thailand, 

Outcome

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