跳至主要内容
临床试验/CTRI/2025/01/079781
CTRI/2025/01/079781尚未招募3 期

A Randomized Open-Labelled Controlled Clinical Study To Evaluate The Efficacy Of Foot Reflexology In The Management Of Anidra With Special Reference To Primary Insomnia.

Dr Namrata1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年2月28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
Significant decrease in the symptoms of Anidra w.s.r to Primary insomnia when assessed by subjective and objective parameters.

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 etc.[2]According to Acharya Vagbhata, Nidra furnishes Sukha, provides Pushti, Bala, Vrishata, Jnana, and Jeevana to Purusha. On the contrary, Anidra causes Dukha, Karshya, Balahrasa, 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  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 insomnia is increasing even in people not suffering from co morbid 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 non hypnotic 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.[9]

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.

Reflexology is a systematic practice in which applying some pressure to particular points on the feet and hands give impacts on the health of related parts of the body. Each point of the pressure acts as the sensors on the feet and hands and links with different parts of body specifically.These sensors will be stimulated by applying the reflexology technique in order to improve the blood and energy circulation which gives sense of relaxation.[11] Reflexology generally is used to solve problems such as stress, anxiety, depression, fatigue and insomnia etc in individuals.[12]

Paadabhyanga is one of the procedures among Bahirparimarjana Chikitsa. According to BrihattrayeesPaadabhyanga brings good sleep, it is pleasing to body and eyes, removes fatigue and reduces Vata Dosha.[13,14,15] According to Acharya Yogaratnakara by massaging the feet it brings strength, induces sleep, beneficial to eyes and reduces tiredness and stiffness of the body.[16]

Considering the above factors, an attempt has been made to clinically evaluate  and compare the efficacy of  Foot reflexology and Paadabhyanga  in 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 Paadabhyanga and Foot reflexology.
  • Subjects who are willing to give written consent for the treatment.

排除标准

  • 未提供

结局指标

主要结局

Significant decrease in the symptoms of Anidra w.s.r to Primary insomnia when assessed by subjective and objective parameters.

时间窗: 0th DAY, 8th DAY, 15th DAY .

Significant differences would be noted between Paadabhyanga with Ksheerabala Taila and Foot reflexology in Anidra when assessed by subjective and objective parameters.

时间窗: 0th DAY, 8th DAY, 15th DAY .

次要结局

  • Generation of in-depth analysed data on the different aspect of the disease & procedure.(Generation of data on possible unexpected/adverse drug reactions or events.)

研究者

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

Dr Namrata

sri sri college of ayurvedic science and research hospital

研究点 (1)

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