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临床试验/CTRI/2024/05/067109
CTRI/2024/05/067109尚未招募2 期

Role of individualised homoeopathic medicine in 50-millesimal scale in the management of insomnia associated with stress- an open label single arm pre-post comparison trial

National Institute of Homoeopathy1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年5月20日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
40
试验地点
1
主要终点
Insomnia Severity Index (ISI)

研究概览

简要总结

Sleep disorder like Insomnia remains a prevalent public health concern, impacting substantial portions of the population at various stages in their lives. Insomnia refers to the condition of experiencing inadequate sleep, typically characterized by challenges in both falling asleep as well as staying asleep and might result in daytime sleepiness. Insomnia disorder affects around 10% of the adult population, whereas approximately 20% of individuals experience occasional symptoms of insomnia. Furthermore, it tends to persist as a chronic condition, with a 40% prevalence rate over a span of five years.Stress, anxiety and depression are among the most common. Studies show that stress in day-to-day life negatively impacts sleep quality and quantity. Dissatisfaction with sleep often exacerbates the stress and this becomes a vicious cycle. Individuals afflicted with insomnia often express dissatisfaction with their sleep patterns, which in turn can significantly impair their ability to perform effectively in various domains such as work, school, and social interactions. Studies show that stress plays an important factor in development of various psychosomatic and somatic disorders and hence it is very important that its relationship with insomnia must be studied in great depth. Homoeopathy is a holistic system of medicine which considers man as a whole, taking note of all the alterations in mind, disposition and body and forms the totality of symptoms which becomes the basis of prescription. Hence homoeopathy works well in treating cases of insomnia that may be associated with changes in mind and disposition.Accordingly, the purpose of this investigation is to evaluate the efficacy of individualized homeopathic medicine in alleviating insomnia symptoms in patients who report experiencing significant stress. A Prospective, Non randomized, Open label, Single arm, Pre- Post Comparison trial with a sample size of 40 patients of Insomnia associated with stress satisfying inclusion and exclusion criteria shall be enrolled for the study. The primary objective is to determine the role of individualized homoeopathic medicine in 50 millesimal scale in the patients of insomnia associated with stress by evaluating changes in Insomnia Severity Index (ISI) at baseline and after 6 months of treatment. The secondary objective is to evaluate changes in Perceived Stress Scale (PSS) using individualized homeopathic medicine in 50 millesimal scale in patients of insomnia associated with stress at baseline and after 6 months of treatment.The sociodemographic data, Insomnia Severity Index and Perceived Stress Scale Score data will be collected once at the Baseline and then after 6 months.The descriptive data will be recorded in terms of absolute values, percentages etc. as appropriate. The score obtained by the patients will be compared and result analysed as per appropriate statistical methods and inference will be done thereafter. The result will be published in scientific journals.

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 of all sexes suffering from Insomnia (ICD-10-CM Diagnosis code: G47.01 ) associated with stress.
  • Patients from all religion and socio-economic backgrounds.
  • Patient who are aged between 18-65 years.
  • Patients with ability to read/write/understand Hindi or English or Bengali.
  • Patient who are willing to participate in the study and giving informed written consent.

排除标准

  • 1.Patients who are too sick for consultation 2.Patient not willing to take part in the study and not ready to give written consent for the same.
  • 3.Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
  • 4.Lactating or Pregnant Women.
  • Undergoing Homoeopathic treatment for any chronic disease from other physician.
  • Patients who are taking allopathic medicines for Insomnia.

结局指标

主要结局

Insomnia Severity Index (ISI)

时间窗: at Baseline and after 6th Month

次要结局

  • Perceived Stress Scale(PSS)(at Baseline & after 6th Month)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Akanksha Saxena

National Institute of Homoeopathy

研究点 (1)

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