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

NCT04182919 | Completed Phase 3

• 1 other identifier: COA-CREC036/2019
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis

Keywords

Zingiber cassumunar; Phlai; compound D; herbal medicine; allergic rhinitis

Outcome Measures

Primary Outcomes (1)

• Total five symptoms score (T5SS)

  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

  24 hours

Secondary Outcomes (12)

• Rhinoconjunctivitis Quality of Life Questionaire (RCQ-36) Thai version

  4 weeks

• Peak inspiratory nasal flow (PNIF)

  2 weeks

• Nasal examination

  2 weeks

• Adverse events

  2 weeks

• AST Level

  4 weeks

Study Arms (3)

Arm 1

EXPERIMENTAL

Phlai 2 capsules (compound D 8 mg) od evening after meal x 4 weeks

Drug: Phlai

Arm 2

EXPERIMENTAL

Phlai 1 capsules (compound D 4 mg) and placebo 1 capsule od evening after meal x 4 weeks

Drug: Phlai; Drug: Placebo oral capsule

Arm 3

PLACEBO COMPARATOR

Placebo 2 capsules od evening after meal x 4 weeks

Drug: Placebo oral capsule

Interventions

Phlai DRUG

Each capsule contains 4 mg compound D. Using orally in the evening everyday in 4 weeks

Also known as: Zingiber cassumunar

Arm 1; Arm 2

Placebo oral capsule DRUG

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

Arm 2; Arm 3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead
• Government Pharmaceutical Organization: collaborator

Study Sites (1)

Minh Phuoc Hoang, MD

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participant, care provider and investigator, outcomes assessor in each site do not know what kind of medication in each package.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participant in each arm will take medication provided by care providers who also do not know what kind of this medication

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: December 2, 2019
• Study Start: January 31, 2020
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Plan to complete study in 2 years and will share the data after get publication

Locations

TH (1)