Clinical study on the immune enhancing effect of Amalakyadi Rasayan in children
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To decrease the morbidity status in children with trial drug.
Study Overview
Brief Summary
Preventable infections constitute the majorcause of morbidity in children and constitute far reaching consequences on theoverall development of a child. Frequent infections and illnesses in childrenmay result in severe limitations in their development and therefore they remaindeprived of many of their opportunities during their childhood.
Although substantial progress has been madein the field of child health care including vaccinations, nutrition etc, manyof the problems remain to be resolved. The most important one are preventivechildhood infectious diseases which are the leading cause of childhoodmorbidity. The major diseases affecting pediatric age group are mostly acutediarrheal diseases, acute respiratory infections, skin diseases, ear dischargesect. Although vaccines are there to prevent some of the infectious diseases andare successful in eradication of some like polio and measles, yet there arediseases for which vaccines are not available and is dreaded life threateningin children. Pneumonia, diarrhea and malaria account for 41% of annual deathglobally Each year, approximately 20,000 children < 5years are hospitalizedbecause of influenza complications. In India, study indicates that, majormorbidities in children are- diarrhea (26%), acute respiratory infections(24.5%) and fever (16.7%)Another study reported that Diarrhea (47.9%) followed by ARI (22.21%), Pica (13%) and WormInfestation (9.21%) were the commonest morbidities in children.
The statistics show that children are morevulnerable to infection because their immune system is less or under developed.Immune system continues to develop as the infant grows. During this periodattempt should be done to prevention of disease and to enhance physical, mentaland social wellbeing of children so that each child may achieve the geneticpotential with which she/he born.There are lots of references regarding the useof lehana and rasayana drugs for protecting the children from variousinfectious diseases, enhancing their bala (immunity) and for their propergrowth and development of the child.Amalakyadi Rasayana described byYogratnakar, Rasayanaadhikar/17 is said to have property of increasing Bala(strength/ immunity).
Therefore, the present study “Clinical Studyon the Immune Enhancing Effect of Amalakyadi Rasayan in Children has beenundertaken with the following objectives:
1. Toobserve the immune enhancing effect of AmalakyadiRasayana
2. Toreduce the morbidity rate in children with trial drug
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 1.00 Year(s) to 10.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Children aged from 1-10 years of either sex.
- •2.Children with recurrent respiratory infections.
Exclusion Criteria
- •1.Subjects suffering from major systemic illness necessitating long term treatment 2.Subjects with evidence of malignancy 3.Subjects with concurrent serious hepatic dysfunction (defined as AST and/or ALT>3 times of the upper normal limit) or renal dysfunction (defined as S.creatinine>1.2mg/dl), uncontrolled pulmonary dysfunction (asthmatic and COPD patients) 4.Co-morbidity like TB, UTI and bleeding disorders etc 5.H/o hypersensitivity to any of the trial drug or their ingredients 6.Subjects who have completed participation in any other clinical trial during the past six months.
Outcomes
Primary Outcomes
To decrease the morbidity status in children with trial drug.
Time Frame: 84 days
Secondary Outcomes
- To observe the immune enhancing effect of Amalakyadi Rasayan(84 days)