CTRI/2011/05/001768已完成未知
A Multicentre Double Blind Parallel Group two Arm Randomized Clinical Study To Evaluate The Safety And Efficacy Of Dabur Honitus Syrup Versus Benadryl Cough Formula Syrup For Symptomatic Relief Of Acute Non Productive Cough And Throat Irritation
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patients with H/O acute non productive cough and throat irritation for less than 1
- •week duration
- •2. Males and Females between 18-65 years age.
- •3. Patients who in the opinion of the Investigator will be able to comply with the
- •study requirements.
- •4. Patients with a cough score of 0, 1 or 2 during day time
- •5. Patients willing and able to provide signed informed consent form prior to any
- •study related procedures.
排除标准
- •1. Patients with H/O lower respiratory tract infections such as Pneumonia,
- •Tuberculosis, Bronchitis, Whooping cough.
- •2. Patients with H/O Chronic Obstructive Pulmonary Diseases/Asthma
- •3. Patients with H/O underlying lung pathology such as lung abscess, cystic fibrosis.
- •4. Patients with known hypersensitivity to ingredients of Investigational Products
- •5. Patients with clinical suspicion of any systemic bacterial infection.
- •6. Patients with H/O Myocardial Infarction (MI) within 4 weeks prior to enrollment
- •7. Patients with immediate life threatening diseases such as pre-existing
- •cardiovascular, liver or neoplastic disease.
- •8. Patients with Hypertension on Angiotensin-converting enzyme (ACE) inhibitors.
- •9. Alcohol, smoke and drug abusers will be excluded. Occasional users of cigarettes
- •and alcohol may pariticpate in the study as per the investigator?s discretion. Such
- •participants should be instructed from restricting the use of cigarettes / alcohol
- •during the study participation period.
- •10. Patients participating in any other clinical trial.
- •11. Pregnant or lactating females.
- •12. Patients who have received any immunosuppressant, Sedative, Hypnotic or
- •Tranquilizer 14 days prior to enrollment.
- •13. Patients who have received any Anti Histaminics, Cough suppressants ,
- •Mucolytics , Expectorants or Antibiotics 3 days prior to enrollment.
- •14. Any other condition due to which patients are deemed to be unsuitable by the
- •Investigator for reason (s) not specifically stated in the exclusion criteria.
- •15. Patients with H/O Parkinson?s disease who are on Mono Amine Oxidase
- •Inhibitors (MAO) inhibitors.
- •16. Any psychiatric illness which may impair the ability to provide written informed
研究者
相似试验
已完成
3 期
A multi-center, double-blind, parallel-group, placebo-controlled, randomized study: evaluation of the efficacy and safety of brivaracetam in subjects (16 to 70 years old) with Partial Onset Seizures.10029305epilepsyNL-OMON31126CB Pharma24
进行中（未招募）
1 期
A multi-center, double-blind, parallel-group, placebo-controlled, randomized study: evaluation of the efficacy and safety of brivaracetam in subjects (>= 16 to 70 years old) with Partial Onset Seizures.Estudio multicentrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos: evaluacion de la eficacia y la seguridad del brivaracetam en sujetos (edad >= 16 a 70 anos) con crisis de inicio parcial. - POS Phase 3Partial Onset SeizuresCrisis de inicio parcialMedDRA version: 9.1Level: LLTClassification code 10015037Term: EpilepsyEUCTR2006-006344-59-ESCB Pharma399
进行中（未招募）
不适用
A multi-center, double-blind, parallel-group, placebo-controlled, randomized study: evaluation of the efficacy and safety of brivaracetam in subjects (>= 16 to 70 years old) with Partial Onset Seizures. - POS Phase 3EUCTR2006-006344-59-NLCB Pharma500
进行中（未招募）
1 期
A multi-center, double-blind, parallel-group, placebo-controlled, randomized study: evaluation of the efficacy and safety of brivaracetam in subjects (>= 16 to 70 years old) with Partial Onset Seizures. - POS Phase 3Partial Onset SeizuresMedDRA version: 9.1Level: LLTClassification code 10015037Term: EpilepsyEUCTR2006-006344-59-FRCB Pharma399
进行中（未招募）
1 期
A multi-center, double-blind, parallel-group, placebo-controlled, randomized study: evaluation of the efficacy and safety of brivaracetam in subjects (>= 16 to 70 years old) with Partial Onset Seizures. - POS Phase 3Partial Onset SeizuresMedDRA version: 9.1 Level: LLT Classification code 10015037 Term: EpilepsyEUCTR2006-006344-59-GBCB Pharma399