跳至主要内容
临床试验/CTRI/2024/06/068876
CTRI/2024/06/068876尚未招募3 期

Randomized open labelled comparative clinical study to evaluate the efficacy of single point and oscillatory method of Shirodhara using Tungadrumadi Taila in Anidra with special reference to Primary insomnia.

Dr Anupama G L1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月30日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Generation of evidence to show that either both methods would provide similar results or one of the two methods would be superior to the other - using Athens Insomnia scale.

研究概览

简要总结

Nidra is one among the Trayopastambha,1 i.e., three pillars of life; any disturbance in it hampers the quality of life. Sleep is the fundamental human need and a crucial component of both physical and mental health. It is vital for restoring energy consumed during the day and plays a key role in maintaining metabolic and endocrine functions, as well as improving cognitive functions like memory.2 According to Acharya Vagbhata, Nidra furnishes Sukha, provides Pushti, Bala, Vrishata, Jnana, and Jeevana to Purusha. On the contrary, Anidra causes Dukha, Karshya, Bala Hrasa, Kleebata, Ajnana, and Marana. 3 Thus, Anidra may hamper the equilibrium of the Tridoshas leading to severe derangement in Dhatus. In contemporary science, due to the close resemblance in the Lakshanas, Anidra can be correlated with primary insomnia. The American Academy of Sleep Medicine defines insomnia as unsatisfactory sleep that impacts daytime functioning.4 Insomnia disorder is highly prevalent in the general population, with estimates of 10% among adults, among them 2-6 % use medications to aid sleep.5 Another Indian study identified 15.4% prevalence of primary insomnia.6 A study among corporate employees in India showed a prevalence of insomnia in 13.8% of participants.7 Insomnia is associated with increased morbidity and mortality caused by cardiovascular diseases and psychiatric disorders and has other major public health and social consequences, such as accidents and absenteeism.8 In developing countries like India the incidence of primary insomnia is increasing even in people not suffering from comorbid chronic physical illness. The Modern medical science is still not having a definite treatment for insomnia. Present treatment includes cognitive behavioural therapy (CBT), use of antihistamines, sedative-hypnotics like benzodiazepines, use of anticonvulsants, antipsychotics, barbiturates and nonhypnotic benzodiazepines. Many of these medications involve a significant level of risk. Most sedative and hypnotic drugs produce a dose-dependent depression of central nervous system function. The use of benzodiazepines produces central nervous depression including drowsiness, impaired motor coordination, confusion, memory loss, blurred vision, hallucinations and paradoxical reactions. The ideal hypnotic drug should allow the patient to fall asleep quickly, should maintain sleep of sufficient quality and duration so that the patient awakes refreshed without a drug hangover.10 The contemporary system of medicine is lacking in fulfilling these criteria. Hence, it becomes imperative to search out treatment that is safe and effective, without any adverse effects or withdrawal phenomena, from natural systems of medicine. Among many modalities mentioned by Acharyas, Shirodhara is an effective treatment for psychiatric and sleep disorders. A study, published by Japanese researchers showed Shirodhara has anxiolytic and ASC-inducing effects, and it promotes a significant decrease in plasma levels of noradrenaline,11 which is one of the key factors in inducing andmaintaining sleep.In clinical practice, Shirodhara is usually practiced in the oscillatory method. Studies related to the single-point method of Shirodhara are needed, to note its efficacy over the oscillatory method. Hence, the study is planned to compare the efficacy of the single point method and oscillatory method of Shirodhara using Tungadrumadi Taila in the management of Anidra.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
21.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Subjects between the age group of 21 – 60 years, irrespective of their gender, religion, occupation, and socioeconomic status.
  • Subjects with insomnia features as mentioned in DSM-5-TR Diagnostic Criteria of Primary Insomnia.
  • Subjects fit for Shirodhara.
  • Subjects who are willing to give written consent for the treatment.

排除标准

  • Subjects below 21 years and above 60 years of age.
  • Subjects with insomnia associated with Psychiatric disorders, Uncontrolled hypertension, uncontrolled diabetes mellitus with polyuria during the night and with HbA1c ≥ 8, with a history of Stroke, Haemorrhagic disorders, Epilepsy, etc.
  • Subjects with insomnia due to alcohol or drug dependency.
  • Pregnant and lactating women.
  • Subjects unfit for Shirodhara.

结局指标

主要结局

Generation of evidence to show that either both methods would provide similar results or one of the two methods would be superior to the other - using Athens Insomnia scale.

时间窗: 0th day, 8th day, 15th day.

次要结局

  • Generation of in-depth analysed data on the different aspects of Shirodhara, Anidra, & primary insomnia.

研究者

发起方
Dr Anupama G L
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Anupama G L

Sri Sri College of Ayurvedic Science and Research, Bangalore.

研究点 (1)

Loading locations...

相似试验