Role of Individualised Homeopathic Treatment in management of Adenoid Hypertrophy in children assessed using Adenoid Obstructive Symptom Checklist: Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Assess the role of individualized homeopathic treatment in management of adenoid hypertrophy in children
研究概览
简要总结
Adenoids (nasopharyngeal tonsils), being part of Waldeyer’s ring, are masses of lymphoid tissues located at the junction of the roof and the posterior wall of the nasopharynx. Adenoids act as the first line of defence in a healthy individual protecting against microorganisms and autoimmunity. The cells of the adenoids are responsible to the priming of the immune system in infancy.
The causes of adenoid hypertrophy are not fully known. They are most likely associated with aberrant immune reactions, infections, environmental exposures and hormonal or genetic factors.
Globally, adenoid hypertrophy (AH) is one of the most prevalent upper respiratory tract disorders of children, with associated troublesome symptoms such as sleep apnea and cognitive disturbances.
An exact incidence and prevalence statistics in current available literature is not available but a meta-analysis study suggests that in a randomized representative population, the prevalence of AH was 34%.
Studies suggest that the health impact status of adenoids is significant. Literature suggests that conventional medical treatment is not able to prevent adenoidectomy and only delay it.
Though studies reveal that the quality of life improves after adenoidectomy, other studies reveal that the symptoms relief is short lasting in some while in other cases symptoms either persist or there could also be a relapse.
The role of Homeopathy in cases of Adenoids has been explored in a prospective, observational multicentric trial and has been found to play a beneficial role in the management of symptomatic AH in children.
On a literature search, two RCTs studied the efficacy of pre-determined homoeopathic medicines in adenoid hypertrophy but couldn’t
yield statistically significant results.
Hence, this RCT aims at understanding what role Individualized Homeopathic Treatment plays in cases of Adenoid Hypertrophy
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Year(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •Informed consent given by the parents or guardians.
- •Children of both the sexes in Pediatric age group from 1 year to 5 years.
排除标准
- •Case of adenoid hypertrophy with grade 4 obstruction on radiological evaluation.
- •Cranio facial anomalies congenital or acquired, diagnosed with a neuromuscular disorder, a recognized congenital syndrome, a coagulation or bleeding disorder, and or severe laryngomalacia; malignancy; tracheostomy in situ.
- •Children with diagnosed psychiatric illness.
结局指标
主要结局
Assess the role of individualized homeopathic treatment in management of adenoid hypertrophy in children
时间窗: Change in symptoms will be assessed every month for 6 months(0,1,2,3,4,5,6) using adenoid symptom checklist.
次要结局
- To evaluate if individualized homeopathy treatment reduces the size of Adenoids in Adenoid Hypertrophy.(X-Ray for assessing the adenoid/nasopharyngeal (A/N) ratio at 0 months and Post Treatment (at 6 months))
研究者
Dr Dhanashree Jayant Bhalerao
Dr.M.L.Dhawale Memorial Homeopathic Institute, Palghar