Clinical Study to Evaluate the Efficacy of Complementary Food (Kidison) in Respiratory Health and Overall Well-being in Children- Randomized Open Label Clinical Study
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Clinical improvement as assessed by clinical examination1 Reduction in frequency of URTI 2 Improvement in appetite 3 weight gain 4 reduction in antibiotic usage Assessment will be done on the scale of 0 to 3 0 is nil 1 is mild 2 is moderate 3 is severe The scoring will be in turn correlated with response to the treatment as follows Poor response less than 25 percent reduction Moderate response 25 to 49 percent Good response 50 to74 percent Excellent response 75 percent
研究概览
简要总结
This will be a randomized open label clinicalstudy In this study 120 Subjects who fulfilthe inclusion criteria will be selected and grouped into two groups Accordingto randomization Group 1 consists of 60 subjects and will receive standardtreatment plus regular diet followed by regular diet for 6 months and follow up for 3 more months after the completion of thestudy and Group 2 consists of 60 subjects and will receive standard treatment plusKidison one serving of 20 grams two orthree times daily with regular diet followed by Kidison one serving 20 gramstwo or three times daily along with their regular diet for 6 months If the results are showing improvement and the studywill be discontinued and the patients will be observedfor next three months 9 months from the start date If the results are not of major improvement then the study will be continued for a furtherperiod of 3 months and the patients will be observed for next three months12 months from the start date
Follow up visits end of every 3 monthsClinical assessment will be carried out at all scheduled study visits likebefore and end of the study period 6 months or at the end of 9 months comparedwith baseline and end of the study The severity of the clinical symptoms willbe recorded based on Complete Blood count C reactiveprotein and IL 1 Severity of theclinical symptoms will be recorded based on a scale 0 to 3 where 0 to nil 1 ismild 2 is moderate 3 is severe Laboratory examination will be carried duringscreening and at the end of the study and the values will be compared
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2.00 Year(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •Both male and female children in the age group of 2 to 6 years Subjects who present with mild occasional cold, cough, sore throat, fever, heaviness of head or headache Loss of appetite rhinorrhea sneeze nasal congestion lethargy tiredness or fatigue Subjects or LAR willing to give written informed consent Subjects who are willing to maintain their regular diet pattern and refrain from taking any other beverages known to relieve cold& cough Subjects who have not participated in similar kind of study in last 4 weeks.
排除标准
- •Subjects with chronic obstructive respiratory disorders, gastrointestinal disorders Subjects who had undergone any surgery in the recent past Subjects with chronic upper or lower respiratory tract infection Subjects who are on any antibiotics anti allergic or anti inflammatory medications Subjects with established cardio pulmonary disorders hypertension renal or hepatic or cardiac failure Subjects with endocrine disorders Subjects currently using prescription medication to treat respiratory conditions Subjects who are not willing to sign informed consent form.
结局指标
主要结局
Clinical improvement as assessed by clinical examination1 Reduction in frequency of URTI 2 Improvement in appetite 3 weight gain 4 reduction in antibiotic usage Assessment will be done on the scale of 0 to 3 0 is nil 1 is mild 2 is moderate 3 is severe The scoring will be in turn correlated with response to the treatment as follows Poor response less than 25 percent reduction Moderate response 25 to 49 percent Good response 50 to74 percent Excellent response 75 percent
时间窗: six & nine months
次要结局
- To assess the occurrence of any adverse(To assess events & overall compliance of the subject to the study intervention)