CTRI/2020/03/023788已完成4 期
Multi-centric, Open label, Single arm, Clinical Study to Evaluate the Efficacy and Safety of Kafnorm® Syrup for Symptomatic Relief of Dry or Productive Cough.
Virgo UAP Pharma Pvt0 个研究点目标入组 52 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. Age 18â??50 completed years.
- •2. History of acute dry or productive cough <= 1-week duration.
- •3. Cough score of 0,1,2 as per day time cough scale.
- •4. Willing to give written informed consent.
- •5. Able to comply with study requirements.
- •6. Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study.
- •7. Patient willing to refrain from smoking, alcohol, etc.
排除标准
- •1. Age < 18 years.
- •2. Pregnant (as per urine pregnancy test) or lactating female patient.
- •3. Past history of drug abuse and alcohol consumption since last 6 months.
- •4. Symptoms of the cough for more than 1 week.
- •5. Known immune deficiency.
- •6. Lung disease (include asthma or COPD).
- •7. Other respiratory disorders like Tuberculosis, chronic bronchitis, asthma, suspected pneumonia, suspected bacterial infections etc.
- •8. History / current condition of Cardiac disease like cardiomegaly, myocardial infraction, mitral regurgitation etc.
- •9. Gastrointestinal symptoms such as nausea, vomiting, abdominal pain or diarrhea.
- •10. Difficulty in filling in the patient diary.
- •11. History of uncontrolled Diabetes Mellitus.
- •12. Current smoker, Smoking history >10 packs per month.
- •13. Patient who received other medications and antibiotic (give all details) for cough within 3 days prior to Investigation drug administration.
- •14. History of or patients taking any medication that causes cough.
- •15. History of homemade therapy and patient not willing to refrain from such medications, therapy, home-made therapy during the treatment phase.
- •16. Patient agreed to avoid such condition like certain foods like cold foods, cold drinks, cough induced lifestyle and cold environmental conditions.
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