A Randomized Single Blind Clinical trial Comparing the efficacy of Individualized Homoeopathic Medicine versus Agraphis Nutans 6C in pediatric Adenoid Hypertrophy Grade I and Grade II.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- To evaluate quality of life changes in comparative study of individualised homoeopathic medicine versus Agraphis Nutans 6C using the OSA-18 questionnaire
研究概览
简要总结
Background: Adenoid hypertrophy (AH) is one of the most common pediatric ENT disorders, affecting 20–40% of children worldwide and up to 40% in India. It often leads to nasal obstruction, sleep-disordered breathing, recurrent infections, and impaired quality of life. Conventional treatments such as corticosteroids provide only temporary relief, while adenoidectomy carries risks of surgical complications and recurrence. Homeopathy, particularly Agraphis nutans, has shown potential in managing AH, but direct comparative studies with individualized homeopathic prescriptions are lacking.
Aim: To compare the efficacy of individualized homeopathic medicine with Agraphis nutans 6C in children with Grade I and Grade II adenoid hypertrophy.
Methods: This is a randomized, single-blind, controlled clinical trial conducted at Bharati Vidyapeeth Homoeopathic Medical College and Hospital, Pune. Children aged 4–12 years with Grade I or II AH confirmed by nasal endoscopy and persistent symptoms for over three months will be included. Participants will be randomized into two groups:
Group A: Individualized homeopathic medicines prescribed on the basis of totality of symptoms.
Group B: Agraphis nutans 6C, administered daily.
Primary outcome will be improvement in quality of life using the OSA-18 questionnaire. Secondary outcomes include reduction in adenoid size (via nasal endoscopy) and changes in severity scores. Data will be analyzed using appropriate statistical methods, primarily paired t-test.
Expected Outcomes:
The study seeks to generate evidence regarding the comparative effectiveness of individualized homeopathy and Agraphis nutans 6C in managing pediatric AH, offering a potential non-invasive and safe alternative to conventional therapy.
Conclusion:This trial will address the existing research gap and may guide clinicians and parents toward safer, individualized treatment strategies for pediatric adenoid hypertrophy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 4.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Prediagnosed cases Grade I and Grade II Adenoid Hypertrophy.
- •Persistent symptoms of nasal obstruction,snoring,or mouth breathing lasting for more than 3 months.
排除标准
- •Previous adenoidectomy Use of nasal corticosteroid within 1 month Craniofacial anomalies or neuromuscular disorder Grade III and Grade IV adenoid hypertrophy complications Nasal polyp Nasal obstruction due to anatomic malformations (i.e.choanal atresia or diaphragm,septal deviations etc.).
结局指标
主要结局
To evaluate quality of life changes in comparative study of individualised homoeopathic medicine versus Agraphis Nutans 6C using the OSA-18 questionnaire
时间窗: Quality of life assessed using the OSA-18 questionnaire at baseline and at end of 18 months study period.
次要结局
- Assessment of severity (mild, moderate, severe)(to compare the reduction in adenoids size between individualised homoeopathic medicines and agraphis nutans 6C)
研究者
DrSwapnali Dilip Patil
BVDUHMC