A STUDY ON THE EFFECTIVENESS OF INDIVIDUALIZED HOMOEOPATHIC MEDICINES IN IMPROVING THE QUALITY OF SLEEP AMONG POST MENOPAUSAL WOMEN
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
- The outcome will be assessed with the reduction in scores of Women’s Health Initiative Insomnia Rating Scale (WHIIRS)
研究概览
简要总结
AIM
To evaluate the improvement in the quality of sleep among postmenopausal women after the administration of Individualized Homoeopathic medicines.
BACKGROUND AND JUSTIFICATION
Sleep disorders occur to both males & females of all ages. But the various studies shown the results that the prevalence is higher in women than men of age above 45 years. There are multi factorial causes leading sleep disorders, among them menopausal insomnia is quite under-rated to get attention for getting proper treatment. Many clinical studies were conducted in modern medicine, but in Homoeopathy, many existing studies highlighting the role of Homoeopathic medicines in insomnia separately and in the management of menopause separately. Therefore, this study is justified to explore the potential of individualized Homoeopathic medicines in improving sleep quality in postmenopausal women, using Women’s Health Initiative Insomnia Rating Scale.
HYPOTHESIS
Null hypothesis (H0): There is no significant improvement in the sleep quality among post-menopausal women after the administration of Individualized Homoeopathic medicines.
Alternative hypothesis (H1): There is a significant improvement in the sleep quality among post-menopausal women after the administration of Individualized Homoeopathic medicines.
METHODOLOGY
A sample of 40 cases will be selected based on purposive sampling. With the patient consent, detailed case taking will be done. The patient will be assessed at baseline with the (WHIIRS) Women’s Health Initiative Insomnia Rating Scale as pre assessment. After case taking, the totality of symptoms will be obtained through the analysis and evaluation of symptoms. With the help of proper repertorization and Homoeopathic Materia Medica, final selection of remedy will be done by Individualization. Then the Individualized Homoeopathic medicine will be prescribed with the proper dose, potency, and repetition of medicines according to the Homoeopathic principles. Follow up will be done 15 days once and every change in the quality of sleep will be assessed monthly once using Women’s Health Initiative Insomnia Rating Scale as post assessment.
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
- 45.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- Female
入选标准
- •Females above 45yrs of age, who attained menopause naturally.
- •Cases who satisfying the points mentioned in verbal questionnaire as per National Institute for Health and Care Excellence guideline.
- •Cases satisfying Women’s Health Initiative Insomnia Rating Scale whose score is above 9 comprises of moderate and severe insomnia.
排除标准
- •Patients who are having sleep disturbances due to inadequate sleep hygiene (daytime napping, irregular sleep-wake schedule, use of stimulants like caffeine or tobacco near bedtime), serious psychiatric conditions (schizophrenia, bipolar disorders, mania), neurologic disorders (myoclonus, dementia, parkinsonism).
- •Patients under any other serious systemic complications and illnesses that aggravates at night time.
- •Patients engaged in night shift work.
- •Patients who are under medications, drugs & stimulants that changes the sleep pattern.
结局指标
主要结局
The outcome will be assessed with the reduction in scores of Women’s Health Initiative Insomnia Rating Scale (WHIIRS)
时间窗: 6 months
01 to 04 Mild improvement
时间窗: 6 months
05 to 09 Moderate improvement
时间窗: 6 months
above 10 Marked improvement.
时间窗: 6 months
次要结局
- The improvement in the quality of sleep among Post menopausal women is considered to indicate that Individualized Homoeopathic medicines are effective.(6 months)
研究者
Dr SUJITHA T
WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL