"Efficacy and Safety of Phlai Capsule Compared to Placebo as the Treatment in Allergic Rhinitis Patients"
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 267
- 试验地点
- 1
- 主要终点
- Total five symptoms score (T5SS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Participant, care provider and investigator, outcomes assessor in each site do not know what kind of medication in each package.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm 3
Placebo 2 capsules od evening after meal x 4 weeks
干预措施: Placebo oral capsule (Drug)
Arm 1
Phlai 2 capsules (compound D 8 mg) od evening after meal x 4 weeks
干预措施: Phlai (Drug)
Arm 2
Phlai 1 capsules (compound D 4 mg) and placebo 1 capsule od evening after meal x 4 weeks
干预措施: Phlai (Drug)
Arm 2
Phlai 1 capsules (compound D 4 mg) and placebo 1 capsule od evening after meal x 4 weeks
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Total five symptoms score (T5SS)
时间窗: 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
次要结局
- Rhinoconjunctivitis Quality of Life Questionaire (RCQ-36) Thai version(4 weeks)
- Nasal examination(2 weeks)
- Adverse events(2 weeks)
- Creatinine level(4 weeks)
- AST Level(4 weeks)
- BUN(4 weeks)
- Eosinophils blood level(4 weeks)
- Peak inspiratory nasal flow (PNIF)(2 weeks)
- Platelet level(4 weeks)
- ALT Level(4 weeks)
- Lymphocyte blood level(4 weeks)
- Hemoglobin(4 weeks)
研究者
Minh Phuoc Hoang, MD
Principal Investigator
Chulalongkorn University