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| Name | Class |
|---|---|
| Government Pharmaceutical Organization | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Phlai 2 capsules (compound D 8 mg) od evening after meal x 4 weeks |
|
| Arm 2 | Experimental | Phlai 1 capsules (compound D 4 mg) and placebo 1 capsule od evening after meal x 4 weeks |
|
| Arm 3 | Placebo Comparator | Placebo 2 capsules od evening after meal x 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phlai | Drug | Each capsule contains 4 mg compound D. Using orally in the evening everyday in 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total five symptoms score (T5SS) | T5SS: (nasal obstruction, rhinorrhea, sneezing, itchy nose, itchy eyes). For each symptom: 0: no symptoms
| 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
| Peak inspiratory nasal flow (PNIF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minh Phuoc Hoang, MD | Bangkok | 10330 | Thailand |
Will plan to share information when finishing study
Plan to complete study in 2 years and will share the data after get publication
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 18, 2022 | |
| Reset | Jul 15, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 18, 2022 | Jul 15, 2022 |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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Participant in each arm will take medication provided by care providers who also do not know what kind of this medication
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Participant, care provider and investigator, outcomes assessor in each site do not know what kind of medication in each package.
| 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 |
|
Use to measure nasal airflow during maximal inspiration
| 2 weeks |
| Nasal examination | Outcome assessor in each site will check the three symptoms: nasal swelling, pale and nasal discharge by anterior rhinoscopy | 2 weeks |
| Adverse events | Sedation, dizziness, dry mouth, headache | 2 weeks |
| AST Level | Liver function test | 4 weeks |
| ALT Level | Liver function test | 4 weeks |
| Creatinine level | Renal function test | 4 weeks |
| BUN | Renal function test | 4 weeks |
| Eosinophils blood level | CBC test | 4 weeks |
| Lymphocyte blood level | CBC test | 4 weeks |
| Hemoglobin | CBC test | 4 weeks |
| Platelet level | CBC test | 4 weeks |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |