Role of homoeopathic medicines in risk modification of the patients with obstructive sleep apnea using kent’s repertory: a single arm pre and post clinical trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Berlin Questionnaire.
研究概览
简要总结
Obstructive Sleep Apnea is a chronic disorder caused by repetitive collapse of the UA during sleep. Episodes of complete (apnea’s) and partial (hypopneas) cessation of airflow can lead to two main consequences: arousals from sleep and oxyhaemoglobin desaturations. Apnea’s and hypopneas occur in all phases of sleep, but are more common in N1, N2 and rapid eye movement (REM) sleep stages than in N3 sleep.
1.Samples will be selected following preliminary and detailed screening using specified selection criteria.
2.Inclusion and exclusion criteria are strictly followed.
3.After consideration of dropout cases, a minimum 40 patients will be enrolled for the study.
4.Case-taking will be done as per the strict homoeopathic principle.
5.Baseline scoring will be taken using Berlin-Questionnaire
6.Analysis and evaluation of each case will be done.
7.Miasmatic analysis will be done.
8.Repertorization will be done in Synthesis Repertory.
9.Final selection of the remedy will be done after consultation with Materia Medica,
10.Potency, dose and repetition of the indicated remedies will be guided strictly as per homoeopathic principles.
11.General (non-medicinal) management including appropriate diet and regimen will be advised.
12.Subsequent prescriptions (follow-ups) will be generated according to relevant homoeopathic principles and will be recorded in follow-up sheets.
13.The baseline data will be compared with the data obtained after 6th months.
14.The score obtained by the patients will be compared and result will be analyzed as per appropriate statistical methods and interference will be done thereafter.
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •(1) patients willing to take part in the study and ready to give informed patient consent for the same.
- •(2).Patients who are able to either read, write or understand Hindi, English or Bengali.
- •(3).Patients suffering from obstructive sleep apnea with berlin questionnaire score more than or equal to one.
- •(4).Patients without any systemic disease or with known but controlled systemic diseases.
排除标准
- •Pregnant or lactating women.
- •Diagnosed cases of unstable mental or psychiatric illness or other systemic disease affecting quality of life.
- •Substance abuse and/or dependence.
- •Patient who are having malignant diseases/life threatening diseases or immune compromised state or any other diseases who needs surgical intervention.
- •Patients with uncontrolled systemic illness or any organ failure.
- •Currently receiving homoeopathic treatment for any chronic condition.
结局指标
主要结局
Berlin Questionnaire.
时间窗: Baseline and After 6Months.
次要结局
- Sociodemographic Data(After 6 months)
研究者
Dr Wajeeha Qureshi
National institute of Homoeopathy