A Phase 4, Single Arm Trial Assessing the Efficacy and Safety of Imuneks 10 mg Capsules in the Prophylaxis of Cold and the Maintenance of the Good Health State in Healthy Subjects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Prophylaxis of common cold and the change in blood lymphocyte, macrophage, neutrophil, eosinophil and monocyte counts from baseline values after first, third and sixth weeks after the oral use of the study medication.
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of Imuneks 10 mg Capsules in the prophylaxis of cold and the maintenance of the good health state in 70 healthy subjects.
详细描述
Study Design: A Phase 4, single arm, efficacy and safety study.
Phase: Phase IV
Number of Sites: 1 (one)
Study Population: 70 healthy subjects of both genders. (This study is designed as a Phase 4 study aiming to obtain efficacy and safety data from the study group. Estimation of Sample Size and Power for Comparing Two Means with standard deviation for each primary endpoint was performed for determination of the study population. 70 healthy subjects were estimated to be sufficient for obtaining efficacy and safety data from the study group.)
Study Drug: Imuneks 10 mg Capsules, containing 10 mg micronized Beta-1,3/1,6-D-glucan derived from baker's yeast of which at least 80 % is below 10 microns (İMUNEKS FARMA İlaç Sanayi ve Ticaret A.Ş., Turkey)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •physically and mentally healthy as judged by means of a medical and laboratory standard
- •the outcome of the following examinations should be clinically insignificant: medical and surgical history (hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 4 weeks prior to the start of the trial)
- •life style and habits (consumption of alcohol, nicotine, coffee, tea, coke, special diet, drug abuse) should be normal/acceptable
- •body temperature, pulse rate, blood pressure, 12 lead ECG should be normal/acceptable.
- •physical examination (general state and abnormal findings per system: endocrine/metabolic, allergies, drug sensitivities, head, neck, eyes, ears, nose, throat, cardiovascular, respiratory, gastrointestinal, hepatic/biliary, urogenital, musculoskeletal, Iymph nodes, skin, and neurological/psychiatric) should be normal/acceptable
- •laboratory examination (blood/serum examination: sodium, potassium, calcium, chloride, total protein, glucose, creatinine, BUN, uric acid, total bilirubin, AST, ALT, GGT, ALP, haemoglobin, haematocrit, erythrocytes, Ieukocytes, platelet count; HBsAg, HIV-Ab, HCV-Ab; urine examination: urine pH, protein, glucose, ketones, blood, Ieukocytes, bilirubin, nitrites and sediment) should be normal/acceptable.
- •normal body weight in relation to height and age according to weight(kg) BMI = (accepted range 18.5 and30 kg/m2) height (m)2
- •subjects must be competent to sign and have signed a consent form before study entry
排除标准
- •acute or chronic upper airways disease, chronic cough, chronic rhinitis (e.g. allergic rhinitis) or asthma,
- •vaccination against influenza or swine flu
- •within 21 days before the study start, suspected swine flu or influenza, body temperature 38 0C,
- •pregnancy or nursing,
- •use of immunosuppressant, stimulants or common cold therapeutics,
- •bacterial tonsillitis,
- •allergic diathesis or any clinically significant allergic disease (i.e. asthma)
- •any history of drug hypersensitivity (especially to β-glucan and related compounds)
- •presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, haematological, gastrointestinal, neurological, psychiatric or other major diseases
- •clinically significant illness within 4 weeks before the start of the study
- •intake or administration of any prescribed systemic or topical medication within 2 weeks prior to the start of the study; in the case of intake or administration of any prescribed systemic or topical medication within 4 weeks before the start of the study because of an insignificant illness, this should be stated in the CRF.
- •intake or administration of OTC medication (including herbal remedies) within 1 week prior to the start of the study
- •concomitant intake or administration of any systemic or topical drugs (including herbal remedies)
- •treatment with any investigational drug (i.e., drug not yet approved) in the last 2 months (60 days) before beginning of the trial
- •medication with drugs known to alter organs or systems such as barbiturates, phenothiazines, cimetidine, omeprazole etc. within the last 2 months (60 days)
- •major surgery of the gastrointestinal tract except for appendectomy
- •supine blood pressure, after resting for 5 min, higher than 140/90 or lower than 100/60 mmHg
- •supine pulse rate, after resting for 5 min, outside the range of 50 - 90 beats/min
- •any clinically significant abnormality of the ECG (12 leads) recorded in rest
- •laboratory values outside the normal range (Appendix 5) with clinical relevance at entry examination
- •alcohol abuse i.e. regular use of more than 2 units of alcohol per day or a history of alcoholism or drug/chemical abuse (one unit of alcohol equals ½ l of beer, 200 ml wine or 50 ml of spirits) or recovered alcoholics
- •vegetarian or any special diet due to any reason
- •knowledge to have any type of parenterally transmitted hepatitis or carrier of the HBsAg (HBsAg test positive)
- •HIV-Ab test positive
- •Test on anti-HCV antibodies positive
- •legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study
- •evidence of an uncooperative attitude
- •> 10 % non-compliance to the investigational product.
研究组 & 干预措施
Imuneks 10mg
Two capsules of the study drug every morning approximately two hours after breakfast for six weeks
干预措施: Imuneks 10mg (Drug)
结局指标
主要结局
Prophylaxis of common cold and the change in blood lymphocyte, macrophage, neutrophil, eosinophil and monocyte counts from baseline values after first, third and sixth weeks after the oral use of the study medication.
时间窗: 6 weeks
The baseline will be established by taking blood samples from the participants at their first visits. Each participant will report to the study staff any symptoms such as runny nose, cough, nasal congestion and sneezing during 6 weeks after administering the first dose of the study medication. Cold symptoms seen in the first week will be excluded from the evaluations as prophylactic effect will not be assessable before this period.
次要结局
- The number of participants who took sick leaves.(6 weeks)
- Number of Participants with Adverse Events That Are Related to The Study Medication.(6 weeks)