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CTRI Number  CTRI/2024/02/062770 [Registered on: 16/02/2024] Trial Registered Prospectively
Last Modified On: 07/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Yoga & Naturopathy 
Study Design  Single Arm Study 
Public Title of Study   Effect of Yoga based integrated protocol in old age people for sleep loss 
Scientific Title of Study   Effect of Yoga Based Integrated Protocol in Sleep Deprivation Among Geriatric Population – An Open Labelled Clinical Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sholly Elizabeth Kuruvilla 
Designation  PG Scholar 
Affiliation  OPD 2, Swastharakshana,KAHER Shri BM Kanakanawadi Ayurveda Mahavidyalaya, 
Address  OPD2,Swastharakshana,KAHER Shri BM Kanakanawadi Ayurveda Mahavidyalaya,Shahapur,Belagavi
Shahapur,Karnataka
Belgaum
KARNATAKA
590003
India 
Phone  8078036432  
Fax    
Email  shollyelizabeth96@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sandeep S Sagare 
Designation  Reader 
Affiliation  OPD 2, Swastharakshana, KAHER Shri BM Kanakanawadi Ayurveda Mahavidyalaya, 
Address  OPD 2,Swastharakshana,KAHER Shri BM Kanakanawadi Ayurveda Mahavidyalaya,Shahapur,Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9844586894  
Fax    
Email  sandeepsagare@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sandeep S Sagare 
Designation  Reader 
Affiliation  OPD 2, Swastharakshana, KAHER Shri BM Kanakanawadi Ayurveda Mahavidyalaya, 
Address  OPD 2,Swastharakshana,KAHER Shri BM Kanakanawadi Ayurveda Mahavidyalaya,Shahapur,Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9844586894  
Fax    
Email  sandeepsagare@gmail.com  
 
Source of Monetary or Material Support  
OPD 2, KAHERS Shri BM Kankanawadi Ayurveda Mahavidyalaya, Shahapur, Belagavi, Karnataka 
 
Primary Sponsor  
Name  Dr Sholly Elizabeth Kuruvilla 
Address  KAHERS Shri BM Kankanawadi Ayurveda Mahavidyalaya, Shahapir, Belagavi, Karnataka, 590003 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sandeep S Sagare  KAHERS Shri BM Kankanawadi Ayurveda Mahavidyalaya  OPD 2, Department of Swasthavritha, KAHERS Shri BM Kankanawadi Ayurveda Mahavidyalaya,Shahapur,590003
Belgaum
KARNATAKA 
9844586894

sandeepsagare@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethucal Committee KLE Shri BM Kankanawadi Ayurveda Mahavidyalaya  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G478||Other sleep disorders. Ayurveda Condition: NIDRA-VAISHAMYAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Yoga based integrated protocol (Procedure Reference: Textbooks of Yoga, Sushrutha Samhitha, Procedure details: Yoga protocol-150 to 200 minutes in a week Padabhyanga - 15 minutes per day at night)
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Subjects fulfilling the diagnostic criteria
Subjects with age of 60 years and above and either sex
Subjects who are apparently healthy
 
 
ExclusionCriteria 
Details  Age below 60 years
Any known malignancies
Recent history of surgery
Known cases of psychiatric illness like schizophrenia, psychosis, depression, anxiety
Subjects with alcohol dependency or drug dependency
Subjects having sleep deprivation due to pain from long term illness
Subjects who are not willing to participate in the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improve in sleep for sleep deprived geriatric population  30 days(5 days in a week) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Disease Review:

     Sleep deprivation can be classified into two main categories: acute and chronic. Acute sleep deprivation refers to an extended period of wakefulness, while chronic sleep deprivation involves consistently insufficient sleep over multiple days. The condition of sleep deprivation arises when inadequate sleep results in reduced performance, diminished alertness, and a decline in overall health [8]. In the realm of Ayurveda, the ancient system of holistic healing, great emphasis is placed on the concept of "nidra" or sleep. This traditional practice recognizes the vital role of sleep-in maintaining well-being and balance within the body and mind. Just as modern science acknowledges the negative effects of sleep deprivation, Ayurveda underscores the importance of obtaining proper and adequate sleep to ensure optimal physical and mental functioning.

 

 Nidra:

Sleep manifests when an individual’s mind, along with their sensory and motor faculties, becomes fatigued and disengages from external stimuli [9].

Importance of nidra:

The manifold dimensions of happiness and sorrow, sustenance and decline, vigour and frailty, potency and debility, wisdom and ignorance, existence and cessation, all intricately hinge upon the phenomenon of sleep [10][11].

Nidranasha:

Sleep is regarded as one of the three supporting pillars of life, known as "Traya upastambha"[12]. It is also recognized as a Adharaneeya vega (natural urge) that should not be suppressed, as doing so could lead to the onset of various ailments [13]. Consequently, the deprivation of sleep can give rise to severe mental and physical complications. The absence of proper sleep precipitates a series of discomforts such as bodily discomfort, a sense of heaviness, drowsiness, frequent yawning, inertia, fatigue, dizziness, impaired digestion, listlessness, and a host of other afflictions [14]. This issue becomes particularly pronounced during old age due to the heightened physiological presence of Vata dosha [15]. In this stage of life, dhathus (bodily tissues) also tend to assume a depleted state (kashaya avastha), leading to an array of issues, including sleep deprivation. These manifestations not only contribute to a derangement of Vata dosha but also exacerbate its imbalance. Thus, the preservation of sound sleep takes on heightened significance within this demographic. Counteracting a period of wakefulness during the night can be achieved by subsequently sleeping for half the duration of time spent awake. This restorative sleep should ideally take place in the morning hours, and it’s recommended to refrain from consuming food during this period while continuing to rest [16]. 

Geriatric Age:

        Old age should be viewed as a natural and inevitable biological occurrence. The examination of the physical and psychological transformations that accompany the aging process is referred to as gerontology. The attentive management of elderly individuals is known as clinical gerontology or geriatrics [2]. In Ayurveda, the concept of "Jara chikitsa" occupies the seventh position among the eight branches of Ayurveda. This can be correlated with the principles of geriatrics.

The delineation of geriatric age according to different samhithas are as follows:

Sl no

Reference

Opinion about old age

1.      

Charaka Samhitha

Jeerna 60-100 years

2.      

Sushrutha Samhitha

     Parihani (comes under Madhyama) – 40- 70 years

Vridha – Above 70 years

3.      

      Ashtanga Hridaya

    Madhyamam- Up to 70 years

Kshayam – Above 70 years

4.      

Astanga Samgraha

Vridham – After 60 years

5.      

Kashyapa Samhitha

Madhyama - 35-70 years

Vridha Above 70 years

6.      

Hareetha Samhitha

Madhyama – 25-70 years

Vridha – above 70 years

Yoga:

Yoga finds its origins deeply intertwined with the fabric of Indian culture, representing not merely an exercise regimen but a holistic way of life that nurtures physical, spiritual, and mental well-being. This ancient practice comprises various components, encompassing postural activities known as asanas, the art of breath control termed pranayama, and the profound practice of meditation [17]. Evidently, the influence of Yoga extends beyond its philosophical roots, positively impacting sleep-related facets. Among older adults who diligently incorporate Yoga into their routines, remarkable improvements in overall sleep quality are observed, notably fewer instances of sleep disruption, decreased sleep onset latency, reduced daytime impairment, diminished reliance on sleep medications, and a heightened sense of morning rejuvenation. This amalgamation of empirical evidence underscores the transformative potential of Yoga, not only fostering restorative sleep but also contributing to an enhanced sense of vitality and well-being [18]. 

 Pranayama and Omkara Chanting:

Pranayama comprises breathing exercises that strengthen the respiratory muscles, leading to improved tissue perfusion and oxygen saturation. It enhances pranashakti, inducing relaxation in the body and mind, consequently improving sleep quality. Pranayama can also lower catecholamine levels in the plasma, further promoting better sleep [19]. Omkara chanting involves the repetition of the “Om” sound. It also has been found to be effective in addressing sleep issues [20].

Padabhyanga:

According to Acharya Sushrutha, the practice of padabhyanga, which involves massaging the feet, holds several benefits. It is said to promote nidra, improve eye health, alleviate srama (fatigue) and supti (numbness). Additionally, padabhyanga offers a soothing massage to both the feet (pada) and the skin (twak), and is considered as a beneficial daily routine [21]. Two siras located in the feet directly influence the eyes. These siras serve as pathways for the effects of medicinal substances applied through padabhyanga (foot massage). Accumulation of malas (impurities) in these channels can lead to disturbances in sleep.

From a modern perspective, padabhyanga is believed to have a positive impact on key neurotransmitters, serotonin and norepinephrine. These neurotransmitters play a crucial role in regulating various neuropsychological processes, including sleep. Consequently, Pada Abhyanga is thought to facilitate relaxation and promote natural, restful sleep [19].

Drug Review:

Ksheerabala taila is used for padabhyanga. It consists of Ksheera, Bala and Tila taila [22].

                                                                     Table 1

Sl no

Latin name

Part used

Pharmacological properties

     1.

    Sida cordifolia [23]

     Root/whole plant

 Aphrodisiac, cardiotonic, analgesic, diuretic  

     2.

   Sesamum indicum [23]

      Seed oil

 Antioxidant, hepatoprotective, antitumor, hypotensive        

                                                                   Table 2

Slno

Drugs

Rasa

Guna

Veerya

Vipaka

Doshagnatha

   1.

  Bala [23]

 Madhura

Guru, snighdha, pichila

Sheeta

Madhura

Vatapitha shamaka

   2.

 Tila taila [23]

Tikta Kashaya

Laghu

Seetha

Katu

Vataghna

 
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