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

NCT ID: NCT04182919

Last Updated: 2022-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 267 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2021-12-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Arm 1

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

Group Type: EXPERIMENTAL

Phlai

Intervention Type: DRUG

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

Arm 2

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

Group Type: EXPERIMENTAL

Phlai

Intervention Type: DRUG

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

Placebo oral capsule

Intervention Type: 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 3

Placebo 2 capsules od evening after meal x 4 weeks

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: 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

Interventions

Phlai

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Zingiber cassumunar

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Government Pharmaceutical Organization

UNKNOWN

Sponsor Role: collaborator

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Minh Phuoc Hoang, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Minh Phuoc Hoang, MD

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

COA-CREC036/2019

Identifier Type: -

Identifier Source: org_study_id