Effectiveness of Individualised Homoeopathic Medicine in management of Adenoid Hypertrophy in Children- A Prospective Single Arm Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1.Adenoid–Nasopharynx (A/N) ratio on lateral nasopharyngeal X-ray
研究概览
简要总结
Adenoid hypertrophy is a common paediatric condition leading to nasal obstruction, mouth breathing, snoring, and recurrent upper respiratory infections, with possible complications such as otitis media and obstructive sleep-disordered breathing. Homoeopathy offers a holistic, individualised, and non-invasive approach that has shown encouraging results in preliminary studies, but structured clinical evidence remains limited.
This prospective, open-label, single-arm clinical study will be conducted over 12 months at Nehru Homoeopathic Medical College and Hospital, New Delhi. A total of 40 children aged 3–10 years, clinically and radiologically diagnosed with adenoid hypertrophy (A/N ratio >0.5), will be recruited through purposive sampling. Informed consent will be obtained from parents or legal guardians before enrolment. After detailed case taking and analysis, individualised homoeopathic medicines will be prescribed in centesimal or LM potencies, selected on the basis of symptom totality, repertorisation, and standard Materia Medica. Potency and repetition adjusted according to susceptibility and clinical response.
Follow-ups will be conducted monthly for six months, with monitoring of clinical symptoms and NOSE scores. At baseline and at the 6th month, lateral nasopharyngeal X-rays will be performed to calculate the Adenoid–Nasopharynx (A/N) ratio. The primary outcome will be change in A/N ratio and NOSE score from baseline to six months. The secondary outcome will be identification of the most commonly prescribed remedies for adenoid hypertrophy in children.
Data will be documented, compiled, and analyzed statistically. Pharmacovigilance will be maintained throughout the study, with referral to higher centres if adverse events or complications arise. This study seeks to provide structured clinical evidence regarding the effectiveness and safety of individualised homoeopathic treatment as a non-invasive alternative for managing adenoid hypertrophy in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •Children between 3 to 10 years of age, clinically diagnosed with adenoid hypertrophy and presenting with symptoms such as nasal obstruction, mouth breathing, or snoring, will be included in the study.
- •Only those cases with radiological confirmation showing an Adenoid–Nasopharynx (A/N) ratio greater than 0.5 will be enrolled.
- •Participation will be limited to children whose parents or guardians give informed consent and are willing to opt for non-surgical homoeopathic management.
排除标准
- •Children requiring emergency adenoidectomy or those with severe complications such as obstructive sleep apnoea with an A/N ratio above 0.75 will be excluded from the study.
- •Patients with structural abnormalities like deviated nasal septum, cleft palate, or nasal polyps, as well as those with immunodeficiency or chronic systemic illnesses, will not be included.
- •Children with psychiatric or behavioral disorders, a previous history of adenoidectomy, or those receiving concurrent treatment from other medical systems for adenoid hypertrophy will also be excluded.
- •Additionally, refusal to participate or non-compliance with treatment and follow-up will lead to exclusion.
结局指标
主要结局
1.Adenoid–Nasopharynx (A/N) ratio on lateral nasopharyngeal X-ray
时间窗: At Baseline and after 6 months of Treatment
2.Nasal Obstruction Symptom Evaluation (NOSE) score
时间窗: At Baseline and after 6 months of Treatment
次要结局
未报告次要终点
研究者
Dr Mansi Aggarwal
Nehru Homoeopathic Medical College and Hospital