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临床试验/CTRI/2021/12/038531
CTRI/2021/12/038531已完成3 期

A Single Arm Open Labelled Study to Evaluate the Effect of Padabhyanga with Ksheerabala Taila in Insomnia among Breast Cancer Survivors

Dr Veena L1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2021年12月13日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
22
试验地点
1
主要终点
Athens Insomnia Scale Score

研究概览

简要总结

Insomnia is common in breast cancer survivors with an estimate ranging from 19.2%-73%. Insomnia is characterized by complaints of difficulty initiating/ maintaining sleep/ non- restorative sleep which can last for at least one month. Insomnia can deplete not only energy level and mood, but also health, work performance and quality of life.Treatment protocols for insomnia is mainly Hypnotic drugs and cognitive behavioral therapy (CBT). Hypnotic drugs may cause serious side effects such as suicidal thinking. Sedatives and hypnotics lead to CNS toxicities, rebound sleep impairment after discontinuation and ultimately do not cure sleep problem. Lack of CBT therapist and it is not suitable for patients with learning disabilities as it requires structured sessions. Also CBT focus on the patient’s capacity to change themselves. According to Ayurveda, Padabhyanga is a cheap, safe and easy external treatment procedure . According to Susruta, Padabhyanga is Nidrakara, provides wellness to the body and sense organs, relieves fatigue.Literature review shows that by massaging with luke warm oil, tactile and mechano receptors get stimulated  and thus a kinetic energy being developed which leads to the activation of axons at surface level, thereby producing neurotransmitters serotonin and nor epinephrine which regulates sleep. Other findings  from the literature review include  padabhyanga increases  the intensity of brain wave (delta wave) and decreases the level of adrenaline and cortisol, thereby regulates sleep.By doing padabhyanga Ajna chakra and Sahasrara chakra getting stimulated and  activating the hypothalamus functioning normally. It influences sleep rhythm & behavioral pattern and give nourishment to the sensory organs

·         22 breast cancer survivors should be done according to symptoms of anidra  and AIS scale

·         After taking the informed consent, the procedure of padabhyanga will be explained and the bystander will be given proper training

·         The patient is advised to continue padabhyanga for a period of one month.

·         Abhyanga should be done separately on each foot  for 15 minutes at evening

·         Patient is advised to take rest for 10 minutes after abhyanga

·         Patient will be given pamphlet containing the detailed procedure & ksheerabala taila for 15 days .

·         Patient will be advised to report, on 15th day and patient compliance will be enquired and ksheerabala  taila for next 15 days will be given.

·         Assessment of symptoms and AIS scale will be done on 30th day and follow up after 15 days.

Observations and results

Improvement was observed in all domains of Athens Insomnia Scale score, and was found to be statistically significant. Marked reduction was found in total Athens Insomnia Scale score and Athens Insomnia Scale Severity Index and was found to be statistically significant. So, overall the padabhyanga with ksheerabala taila is effective in managing insomnia among breast cancer survivors

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
40.00 Year(s) 至 70.00 Year(s)(—)
性别
Female

入选标准

  • Breast cancer survivors (within 5 years after diagnosis) who have received either chemotherapy and/or who have undergone surgery Patient aged between 40-70 years Patient having Athens Insomnia Scale score ≥ 6.

排除标准

  • Patient diagnosed with severe medical illness including cardiovascular, liver or kidney dysfunction Patient who are taking antidepressants or antipsychotic drugs.

结局指标

主要结局

Athens Insomnia Scale Score

时间窗: Athens Insomnia Scale Score will be assessed on first day before trial and after one month of treatment

次要结局

未报告次要终点

研究者

发起方
Dr Veena L
申办方类型
Other [self]

研究点 (1)

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