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

Sponsor

Chulalongkorn University (Other)

Overall Status

Completed

CT.gov ID

NCT04182919

Collaborator

Government Pharmaceutical Organization (Other)

267

Enrollment

Location

Arms

22.6

Actual Duration (Months)

11.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis	Drug: Phlai Drug: Placebo oral capsule	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

267 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Participant, Care Provider)

Masking Description:

Participant, care provider and investigator, outcomes assessor in each site do not know what kind of medication in each package.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 31, 2020

Actual Primary Completion Date :

Dec 20, 2021

Actual Study Completion Date :

Dec 20, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Total five symptoms score (T5SS) [24 hours]
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

Secondary Outcome Measures

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.
Peak inspiratory nasal flow (PNIF) [2 weeks]
Use to measure nasal airflow during maximal inspiration
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
AST Level [4 weeks]
Liver function test
ALT Level [4 weeks]
Liver function test
Creatinine level [4 weeks]
Renal function test
BUN [4 weeks]
Renal function test
Eosinophils blood level [4 weeks]
CBC test
Lymphocyte blood level [4 weeks]
CBC test
Hemoglobin [4 weeks]
CBC test
Platelet level [4 weeks]
CBC test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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