To evaluate the effectiveness of Calcarea Group in the management of Chronic Suppurative Otitis Media: An Open Label Prospective Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To compare the COMOT-15 score at the baseline and after 6 months of treatment to know the effectiveness of Calcarea group.
研究概览
简要总结
CSOM is a chronic ear infection marked by ear discharge and a permanent perforation of the tympanic membrane. CSOM can result in hearing loss, middle ear inflammation, and ossicular damage. The chronic nature of CSOM, with poor responses to conventional treatments like antibiotics, highlights the need for alternative therapies like homeopathy. CSOM affects millions, causing preventable hearing loss. In countries like India, the prevalence is high, especially in rural areas. Modern treatments are often ineffective, prompting the search for alternative options. Homeopathy, which focuses on individualized treatments, may offer a potential solution.
This study aims to evaluate the effectiveness of homeopathic remedies from the Calcarea group in managing Chronic Suppurative Otitis Media (CSOM), a long-lasting ear infection that causes ear discharge, hearing loss, and tympanic membrane perforation. Current treatments are often ineffective, particularly in the long term, highlighting the need for alternative therapies like homeopathy. The study will involve 30 patients with CSOM, aged 2-50 years, who will receive homeopathic treatment based on detailed case-taking. Their progress will be monitored using the Chronic Otitis Media Outcome Test-15 (COMOT-15), which assesses their quality of life. Patients will be followed up for six months, with regular assessments and data analysis to determine the treatment’s effectiveness.
The study aims to demonstrate that remedies from the Calcarea group can significantly improve symptoms of CSOM, such as ear discharge and hearing loss, and contribute to homeopathic practice in treating this condition. This study aims to assess the effectiveness of the primary medicine from the Calcarea group in cases of Chronic Suppurative Otitis Media (CSOM) and will assist in the clinical validation of the symptoms associated with the prescribed Calcarea group medicine.
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
- 2.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients both male and female will be included in the study.
- •2.Cases of patients between 2-50 yrs of age.
- •3.Patients with clinical symptomatology like otalgia and otorrhea with or without hearing disturbances.
- •4.Cases with duration of discharge more than six weeks used to make the diagnosis.
- •5.Patients who are willing to fill consent form.
- •6.Patient taking no other treatment for CSOM.
排除标准
- •1.Patients who are not willing to give their consent for study and not complying regular follow up.
- •2.Cases with advanced pathology like Cholesteatoma, epidural abscess, meningitis or which requires major surgical interventions.
- •3.Pregnant and lactating women.
- •4.Patients with unstable psychiatric illness or other life-threatening systemic disease.
结局指标
主要结局
To compare the COMOT-15 score at the baseline and after 6 months of treatment to know the effectiveness of Calcarea group.
时间窗: 12 weeks, 24 weeks
次要结局
- The aims to assess the effectiveness of the primary medicine from the Calcarea group in cases of Chronic Suppurative Otitis Media (CSOM) and will assist in the clinical validation of the symptoms associated with the prescribed Calcarea group medicine.(12 weeks, 24 weeks)
研究者
Tulika
State National Homoeopathic Medical College and Hospital