Back to results"Efficacy and Safety of Phlai Capsule Compared to Placebo as the Treatment in Allergic Rhinitis Patients"
Primary Purpose
Allergic Rhinitis
Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Phlai
Placebo oral capsule
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis focused on measuring Zingiber cassumunar, Phlai, compound D, herbal medicine, allergic rhinitis
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
Sites / Locations
- Minh Phuoc Hoang, MD
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm Description
Phlai 2 capsules (compound D 8 mg) od evening after meal x 4 weeks
Phlai 1 capsules (compound D 4 mg) and placebo 1 capsule od evening after meal x 4 weeks
Placebo 2 capsules od evening after meal x 4 weeks
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Peak inspiratory nasal flow (PNIF)
Use to measure nasal airflow during maximal inspiration
Nasal examination
Outcome assessor in each site will check the three symptoms: nasal swelling, pale and nasal discharge by anterior rhinoscopy
Adverse events
Sedation, dizziness, dry mouth, headache
AST Level
Liver function test
ALT Level
Liver function test
Creatinine level
Renal function test
BUN
Renal function test
Eosinophils blood level
CBC test
Lymphocyte blood level
CBC test
Hemoglobin
CBC test
Platelet level
CBC test
Full Information
NCT ID
NCT04182919
First Posted
November 26, 2019
Last Updated
January 27, 2022
Sponsor
Chulalongkorn University
Collaborators
Government Pharmaceutical Organization
1. Study Identification
Unique Protocol Identification Number
NCT04182919
Brief Title
"Efficacy and Safety of Phlai Capsule Compared to Placebo as the Treatment in Allergic Rhinitis Patients"
Official Title
"Efficacy and Safety of Phlai Capsule Compared to Placebo as the Treatment in Allergic Rhinitis Patients"
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 31, 2020 (Actual)
Primary Completion Date
December 20, 2021 (Actual)
Study Completion Date
December 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
Collaborators
Government Pharmaceutical Organization
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
Zingiber cassumunar, Phlai, compound D, herbal medicine, allergic rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Participant in each arm will take medication provided by care providers who also do not know what kind of this medication
Masking
ParticipantCare Provider
Masking Description
Participant, care provider and investigator, outcomes assessor in each site do not know what kind of medication in each package.
Allocation
Randomized
Enrollment
267 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Phlai 2 capsules (compound D 8 mg) od evening after meal x 4 weeks
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Phlai 1 capsules (compound D 4 mg) and placebo 1 capsule od evening after meal x 4 weeks
Arm Title
Arm 3
Arm Type
Placebo Comparator
Arm Description
Placebo 2 capsules od evening after meal x 4 weeks
Intervention Type
Drug
Intervention Name(s)
Phlai
Other Intervention Name(s)
Zingiber cassumunar
Intervention Description
Each capsule contains 4 mg compound D. Using orally in the evening everyday in 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
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
Primary Outcome Measure Information:
Title
Total five symptoms score (T5SS)
Description
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
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Rhinoconjunctivitis Quality of Life Questionaire (RCQ-36) Thai version
Description
This questionnaire is designed to find out how your health and well-being have been affected by rhinoconjunctivitis.
Time Frame
4 weeks
Title
Peak inspiratory nasal flow (PNIF)
Description
Use to measure nasal airflow during maximal inspiration
Time Frame
2 weeks
Title
Nasal examination
Description
Outcome assessor in each site will check the three symptoms: nasal swelling, pale and nasal discharge by anterior rhinoscopy
Time Frame
2 weeks
Title
Adverse events
Description
Sedation, dizziness, dry mouth, headache
Time Frame
2 weeks
Title
AST Level
Description
Liver function test
Time Frame
4 weeks
Title
ALT Level
Description
Liver function test
Time Frame
4 weeks
Title
Creatinine level
Description
Renal function test
Time Frame
4 weeks
Title
BUN
Description
Renal function test
Time Frame
4 weeks
Title
Eosinophils blood level
Description
CBC test
Time Frame
4 weeks
Title
Lymphocyte blood level
Description
CBC test
Time Frame
4 weeks
Title
Hemoglobin
Description
CBC test
Time Frame
4 weeks
Title
Platelet level
Description
CBC test
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Minh Phuoc Hoang, MD
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Will plan to share information when finishing study
IPD Sharing Time Frame
Plan to complete study in 2 years and will share the data after get publication
Learn more about this trial
"Efficacy and Safety of Phlai Capsule Compared to Placebo as the Treatment in Allergic Rhinitis Patients"
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