An open Label, non-randomised, clinical study to evaluate the efficacy of homeopathic formulation of Anacosinum pellets in patient with Flu and Flu like symptoms.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Symptomatic relief from clinical symptoms of Flu and Flu like symptoms
研究概览
简要总结
Alleligible subjects who meet the Inclusion and Exclusion will be enrolled intothe study will have to visit the study site on screening, Day 0 (Baselinevisit) and Day 7.
200subjects will be enrolled.
Subjectsin study will receive active Investigational product and advised to take 1 vialthrice a day before food
Physicalexamination and Demographics will be recorded at screening time.
Physicalexamination and monitoring will be continuing on baseline and Day7.
Vitalswill be recorded on all visits.
Temperature will be recorded daily upto 7 days.
VisualAnalog Scale (VAS) Score on baseline and day 7
(Intensityof pain will be graded from 0-9. Pain intensity will be assessed in each case). Adverseevents will be monitored up to 7 days and will be recorded on day 1 and day 7.A buffer period of ±1 day will be allowed for visit and beyond which it will beconsidered as a protocol deviation.
All the subjects who meet the eligibilitycriteria and have received at least one dose of study medication and had postbaseline efficacy data will be included in the efficacy analysis
All subjects who shall receive at least one doseof study
drug will be included in the safety analysis
Patient data from all the centers will be pooled
together and analyzed using paired t- test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •The Inclusion criteria are as follows (“Yes†to all the following will allow the subjects to be included into study) 1 Age: Adult-Above 18 years to below 60 years, both male and female 2 Willing to sign written inform consent 3 Patients recently diagnosed with Flu, the following signs and symptoms Diagnosis of Mild to Moderate Headache, Body ache and other symptoms of cough cold.
- •Sore throat.
- •Sneezing/ Nasal irritation.
- •Runny nose.
- •With or without low grade fever (<102 F).
排除标准
- •The exclusion criteria are as follows (“Yes†to any one of the following will allow PI to exclude the subject from enrolling into the study 1 Upper Respiratory Tract Infections (URI or URTI) including rhinitis, sinusitis, pharyngitis, tonsillitis, laryngitis, tracheitis and otitis media.
- •2 Lower Respiratory Tract Infections (LRI or LRTI) including pneumonia and acute bronchitis.
- •3 Chronic obstructive airway disease (COAD) including chronic bronchitis and emphysema 4 Bronchial Asthma 5 H/o Pulmonary Tuberculosis 6 Tumours of larynx, bronchi, and lungs 7 Drug-induced Cough (e.g., ACE Inhibitors) 8 Diabetes Mellitus, Hypertension 9 Known cases of severe hepatic, renal or cardiac ailments 10 H/o addiction (smoking, alcohol, drugs) 11 K/h/o hypersensitivity to herbal extracts or dietary supplements 12 Pregnant women, lactating women and women of child-bearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy test.
结局指标
主要结局
Symptomatic relief from clinical symptoms of Flu and Flu like symptoms
时间窗: 7 Days
次要结局
- To assess the safety profile of Anacosinum pellets in Flu and overall compliance to the drug treatment.(7 Days)