Allergic RhinitisPhase 3NCT04182919
"Efficacy and Safety of Phlai Capsule Compared to Placebo as the Treatment in Allergic Rhinitis Patients"
A Phase 3 study testing Phlai in people with Allergic Rhinitis, run by Chulalongkorn University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Phlai
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 267 participants
- Where
- 1 siteThailand
- Study dates
- 31 Jan 2020to 20 Dec 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy and lactation (Urine pregnancy test is allowed and paid by researchers)
- Allergic to any kinds of herb
- Refusal to participation
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Phlai, Placebo oral capsule
- Keywords
- Zingiber cassumunar, Phlai, compound D, herbal medicine, allergic rhinitis
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhlaiDrug
Also called Zingiber cassumunar
Each capsule contains 4 mg compound D. Using orally in the evening everyday in 4 weeks
Placebo oral capsuleDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Phlai 2 capsules (compound D 8 mg) od evening after meal x 4 weeks Receives: Drug: Phlai |
| Arm 2 | Experimental | Phlai 1 capsules (compound D 4 mg) and placebo 1 capsule od evening after meal x 4 weeks Receives: Drug: Phlai; Drug: Placebo oral capsule |
| Arm 3 | Placebo comparator | Placebo 2 capsules od evening after meal x 4 weeks Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (12)
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.
Measured: 4 weeks
Peak inspiratory nasal flow (PNIF)
Use to measure nasal airflow during maximal inspiration
Measured: 2 weeks
Nasal examination
Outcome assessor in each site will check the three symptoms: nasal swelling, pale and nasal discharge by anterior rhinoscopy
Measured: 2 weeks
Adverse events
Sedation, dizziness, dry mouth, headache
Measured: 2 weeks
AST Level
Liver function test
Measured: 4 weeks
ALT Level
Liver function test
Measured: 4 weeks
Creatinine level
Renal function test
Measured: 4 weeks
BUN
Renal function test
Measured: 4 weeks
Eosinophils blood level
CBC test
Measured: 4 weeks
Lymphocyte blood level
CBC test
Measured: 4 weeks
Hemoglobin
CBC test
Measured: 4 weeks
Platelet level
CBC test
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start31 Jan 2020
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participant in each arm will take medication provided by care providers who also do not know what kind of this medication
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- The Government Pharmaceutical Organization
- Responsible party
- Principal investigator, Minh Phuoc Hoang, MD, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182919
- Sponsor's protocol ID
- COA-CREC036/2019
- Status last verified
- Jan 2022
- First submitted
- 26 Nov 2019
- Last updated
- 28 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will plan to share information when finishing study
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Efficacy and Safety of Phlai Capsule Compared to Placebo as the Treatment in Allergic Rhinitis Patients"
- ClinicalTrials.gov ID
- NCT04182919
- Acronym / sponsor ID
- COA-CREC036/2019
- Conditions
- Allergic Rhinitis
- Keywords
- Zingiber cassumunar, Phlai, compound D, herbal medicine, allergic rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- The Government Pharmaceutical Organization
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 2 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Participant in each arm will take medication provided by care providers who also do not know what kind of this medication
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: PhlaiPhlai 2 capsules (compound D 8 mg) od evening after meal x 4 weeks |
| Arm 2 | Experimental | Drug: Phlai, Drug: Placebo oral capsulePhlai 1 capsules (compound D 4 mg) and placebo 1 capsule od evening after meal x 4 weeks |
| Arm 3 | Placebo comparator | Drug: Placebo oral capsulePlacebo 2 capsules od evening after meal x 4 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhlaiAlso: Zingiber cassumunarEach capsule contains 4 mg compound D. Using orally in the evening everyday in 4 weeks | Drug | Arm 1, Arm 2 |
| Placebo oral capsuleLike 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 | Drug | Arm 2, Arm 3 |
Primary outcome
Total five symptoms score (T5SS)
Time frame: 24 hours
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
12 secondary outcomes
Rhinoconjunctivitis Quality of Life Questionaire (RCQ-36) Thai version
Time frame: 4 weeks
Peak inspiratory nasal flow (PNIF)
Time frame: 2 weeks
Nasal examination
Time frame: 2 weeks
Adverse events
Time frame: 2 weeks
AST Level
Time frame: 4 weeks
ALT Level
Time frame: 4 weeks
Creatinine level
Time frame: 4 weeks
BUN
Time frame: 4 weeks
Eosinophils blood level
Time frame: 4 weeks
Lymphocyte blood level
Time frame: 4 weeks
Hemoglobin
Time frame: 4 weeks
Platelet level
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: Yes. Will plan to share information when finishing study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Phlai in people with Allergic Rhinitis, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total five symptoms score (T5SS) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.