| CTRI Number |
CTRI/2024/02/063019 [Registered on: 22/02/2024] Trial Registered Prospectively |
| Last Modified On: |
21/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of sheetali and sheetkari pranayama in anxiety Patients. |
|
Scientific Title of Study
|
Immediate effect of sheetali and sheetkari pranayama in generalised anxiety disorder - A randomized controlled 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 C JEEVAJOTHI |
| Designation |
Post-graduate scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical
Sciences, Faculty Block (Ground Floor),PG class room no 1, Department of Yoga,
Kamarajar Nagar, Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
7010615368 |
| Fax |
|
| Email |
gjonatureheals@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Gayathri |
| Designation |
Head Of Department (Yoga) |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical
Sciences,PG class room no 1, Faculty Block (Ground Floor), Department of Yoga,
Kamarajar Nagar, Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
8124634017 |
| Fax |
|
| Email |
gayathriannamalai93@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr C JEEVAJOTHI |
| Designation |
Post-graduate scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical
Sciences, Faculty Block (Ground Floor),PG class room no 1, Department of Yoga,
Kamarajar Nagar, Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
7010615368 |
| Fax |
|
| Email |
gjonatureheals@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
|
|
Primary Sponsor
|
| Name |
Dr C JEEVAJOTHI |
| Address |
184/4 , International Institute of Yoga and Naturopathy Medical
Sciences, Faculty block, Department of Yoga,
Kamarajar nagar, Chengalpattu. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr C JEEVAJOTHI |
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
184 4 International Institute of Yoga and Naturopathy Medical
Sciences Faculty Block Ground Floor Department of Yoga
Kamarajar Nagar Chengalpattu
Kancheepuram
TAMIL NADU |
7010615368
gjonatureheals@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| International institute of Yoga and Naturopathy Medical Sciences, Chengalpattu Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F411||Generalized anxiety disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No intervention |
Patient’s breathing will be observed in supine lying position without
giving any intervention for 30 minutes. |
| Intervention |
Sheetali pranayama,Sheetkari pranayama |
Sheetali pranayama:
The participants were instructed to coil their tongues sides up into a tube and stretch their tongues as far as they could without exertion outside of their mouths. Patients are told to breathe in through the
tongue for 4 seconds (sec) while keeping their eyes open The tongue was pulled in, the mouth was closed, and exhalation was performed through the nostrils.
Sheetkari pranayama:
Patients are instructed to slightly close their mouths , expand their cheeks and bring the teeth together
slightly. Patients are told to inhale deeply and slowly through the space between their teeths and exhalation done slowly through the nostrils.
The study group will be instructed to practice sheetali and sheetkari pranayama for 30 mins with 3 mins of rest in between the practice.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Person between the age group of 20 years to 75 years will be included. Both Male and Female, who were diagnosed generalized anxiety disorder according to
Generalized Anxiety Disorder scale-7 questionnaire will be included. Patients who are willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
The person who is undergoing continues practice of yoga, suffering from cold, missing teeth or dentures, dental caries, sensitive teeth, low blood pressure or COPD,secondary hypertension and who have Current or past diagnosis of psychosis, schizophrenia, bipolar disorder, panic disorder with agoraphobia, major depressive disorder, social phobias, obsessive compulsive disorder, posttraumatic stress disorder or substance dependence are not included |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of anxiety level will be measured using Hamilton Anxiety rating Scale (HAM-A) questionnaire |
Immediately after the intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood pressure |
Immediately before & after the intervention using a non-invasive arm type
Omron automatic blood pressure monitor. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 2 |
|
Date of First Enrollment (India)
|
04/03/2024 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Generalized anxiety disorder is described as chronic and persistent worry that occurs for at least 6 months. This disorder has multiple causes (e.g. About finances, family, health, and the future) which is excessive and difficult to control, when intensified it is typically accompanied by psychological and physical symptoms like restlessness, fatigue, facing difficulty in concentrating on something, irritability, muscle tension and sleep disturbance. This disorder is associated with depression, alcohol, substance abuse, physical and mental health problems.Anxiety has been divided into three categories by psychologists: trait, state condition, and situation specific. An element of personality and a more enduring tendency to worry is called as trait anxiety. Nothing triggers it; nothing happens. state anxiety can be thought of as a reaction to a specific anxiety provoking event. The phrase "situation particular anxiety" has lately been used to highlight the enduring and complex character of some anxieties. It was sparked by particular circumstances, like worry about public speech Low socioeconomic standing, being bereaved, separated, or divorced are all risk factors for generalized anxiety disorder, which affects women more frequently than males. Women in their middle years are more likely to develop generalized anxiety disorder. The average age of onset for generalized anxiety disorder is 31 years old, and approximately 4% of individuals worldwide may experience it at some time in their lives. At the worldwide level, anxiety illnesses affect 4.6% more women than men (compared to 2.6% for depression). A nationwide group of women’s health experts suggested in 2020 that all women aged 13 and older to undergo an anxiety screening. According to the fifth criteria of the most recent Diagnostic and Statistical Manual of Mental Disorders, generalized anxiety disorder has a weighted incidence rate of 5.8% in the Indian community. A lifelong prevalence of 4.2% to 5.8% indicates that generalized anxiety disorder is a prevalent and severe condition. The World Health Organization estimates that in 2015, 3.6% of the world’s population suffered from anxious illness Yogic breathing exercises are known as pranayama are known to enhance both physical and emotional health. It is well known that yoga has a profound effect on how the nervous system functions, reduces tension, and fosters calm. Additionally, they cool down the body and the brain and reduce bodily heat by practicing Sheetali and Sheetkari pranayama. After performing other asanas and pranayamas, one typically performs Sheetali Pranayama, also known as the cooling breath. The body is cooled by Sheetali pranayama. The Sanskrit word sheetali means "cooling." The yoga books Hatha Yoga Pradeepika and Gheranda Samhita both mentioned about sheetali pranayama. Those who find it difficult to do Sheetali Pranayama can easily practice Sheetkari and get similar benefits .There are different types of Pranayama like Ujjai, Bastrika, Vibhagha, Nadi Sodhana, Nadi shuddi, |