| CTRI Number |
CTRI/2025/03/083151 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| 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
|
Chandranadi Pranayama on Heart rate variability in Primary Insomnia patients |
|
Scientific Title of Study
|
Effect of Chandranadi Pranayama on Heart rate variability among Primary Insomnia- A Randomized Controlled Study |
| 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 ALAMELUMANGAI M |
| Designation |
Post Graduate Scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block (First floor),Department of Yoga, Kamarajar nagar, Chengalpattu, Kancheepuram
Kancheepuram TAMIL NADU 603001 India |
| Phone |
9629831032 |
| Fax |
|
| Email |
sarayumuthuvel@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr A Gayathri |
| Designation |
Head(i/c) of Department (Yoga) |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block (First floor), Department of Yoga, Kamarajar nagar, Chengalpattu, Kancheepuram
Kancheepuram TAMIL NADU 603001 India |
| Phone |
8124634017 |
| Fax |
|
| Email |
gayathriannamalai93@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr ALAMELUMANGAI M |
| Designation |
Post Graduate Scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block (First floor), Department of Yoga, Kamarajar nagar, Chengalpattu, Kancheepuram
Kancheepuram TAMIL NADU 603001 India |
| Phone |
9629831032 |
| Fax |
|
| Email |
sarayumuthuvel@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu 603001, Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
Dr ALAMELUMANGAI M |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty block(First floor), Department of Yoga, Kamarajar Nagar, Chengalpattu-603001, Kanchipuram, Tamilnadu |
| 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 Alamelumangai M |
International Institute of Yoga and Naturopathy Medical Sciences |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block (First Floor), Department of Yoga, Kamarajar Nagar, Chengalpattu Kancheepuram TAMIL NADU |
9629831032
sarayumuthuvel@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: F510||Insomnia not due to a substance orknown physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Adopting Sukhasana |
Resting in Sitting Position for 5 minutes |
| Intervention |
Chandranadi Pranayama |
The study participants will
receive one day of orientation
program before the trial. The
study participants will be asked
to sit in sukhasana, Keep the
eyes closed throughout the
practice. Inhale and exhale slowly and
deeply through the left nose. Subjects will be instructed to breathe in and out with a regularity of counts at the rate of 10 breaths/min (BPM) for 1 minute followed by 15 seconds relaxation. Continue to practice in the same way for 4 successive rounds for 5 minutes to complete 40 rounds of CNP for a period of 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Sleeplessness for at least 1 month. Likert type scale score ranging from 8-21 in Insomnia Severity Index. People who are ready to give willing consent. |
|
| ExclusionCriteria |
| Details |
Study participants who have any systemic illness.
Individuals who are not willing to participate.
Participants who are pregnant and lactating mothers.
Secondary insomnia
Intake of antipsychotic or antidepressant drugs |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Heart Rate Variability (HRV) |
Assessment of Heart Rate Variability (HRV) before and after the intervention in Primary Insomnia for 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Systolic & diastolic blood pressure, Heart rate & pulse rate, PSQI scale & ISI Scale |
Assessment of Systolic & diastolic blood pressure, Heart rate & pulse rate, PSQI scale & ISI Scale before & after the intervention in Primary Insomnia for 4 weeks |
|
|
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)
|
01/04/2025 |
| 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 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - ONLINE
- For how long will this data be available start date provided 10-02-2025 and end date provided 11-03-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Insomnia is a common sleep disorder that affects a significant portion of the global population. Problems falling or staying asleep, or getting up too early and not being able to go back to sleep, are the hallmarks of this condition. Insomnia can have a range of negative effects on an individual’s physical, emotional, and cognitive health, including fatigue, irritability, impaired cognitive function, and an increased risk of accidents and injuries. The American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) defines Insomnia as a complaint regarding the quantity, quality, or sleep timing at least 3 times a week for at least 1 month. Studies have established insomnia to be a very common condition with symptoms present in about 33–50% of the adult population. Its prevalence ranges from 10 to 15% among the general population, with higher rates seen among females, divorced or separated individuals, those with loss of loved ones, and older people. Insomnia can be classified into several subtypes such as Acute, chronic, Primary, Secondary and other insomniac disorder based on the duration and frequency of symptoms. Primary insomnia refers to insomnia that is not caused by an underlying medical or psychiatric condition, while secondary insomnia refers to insomnia that is caused by a comorbid condition or a medication. And, it is commonly defined as sleep difficulties that affect daytime functioning; it does not occur in the presence of another sleep disorder, mental disorder, or as the direct physiological effect of a substance or medical condition. Insomnia is consistently more prevalent among women, middle-aged and older adults, shift workers, and patients with coexisting medical and psychiatric disorders. Although insomnia has a greater overall prevalence in adults, the nature of insomnia interacts with age, such that sleep maintenance difficulties are more common among middle-aged and older adults, whereas sleep initiation difficulties are more frequent among younger adults. A worldwide study found that the highest prevalence rates of insomnia were in Brazil (79.8%), followed by South Africa (45.3%), Eastern Europe (32%), Asia (28.3%) especially in India(12.7%), and Western Europe (23.2%). Treatment of insomnia should be individualized based on the nature and severity of symptoms and should occur after other causes have been considered, diagnosed, and treated. Treatment options for insomnia that do not involve drugs include relaxation techniques, cognitive behavioral therapy, stimulation control therapy, paradoxical intention therapy, sleep restriction therapy, temporal control therapy, better sleep hygiene, and moderate exercise. Yoga is a practice that includes Eight Limbs such as spiritual concepts (yamas and niyamas), body postures (asanas), breathing manipulations (pranayamas), concentration/focusing techniques (dharana), meditation (dhyana) and surrendering (Samadhi). Among Pranayama is the Fourth Limb. Pranayama is a breath control practice. In Sanskrit term, Prana+ayama means Vital energy or Life force. Different pranayamas cause unique physiological and cardiovascular responses in individuals. Swarodaya Vigjnan, from the Vedic language, means "knowledge of the nasal cycle" (swara = sonorous sound created by the airflow through the nostrils in the nasal cycle, udaya = functioning state). When practicing pranayama, or the yoga breathing method, dominance of the left nostril (called "ida" swara) triggers parasympathetic activity. The nasal cycle is influenced by the amounts of neurohormones and catecholamines in the blood as well as the tonic activity of the limbic autonomic nervous system, which is regulated by the hypothalamus. The peripheral nervous system’s autonomic nervous system controls involuntary physiological functions like blood pressure, breathing, and heart rate. Stimulation of the left brain hemisphere causes sympathetic activity, while stimulation of the right hemisphere causes parasympathetic activity. One of the many essential biological processes that the autonomic nervous system regulates is sleep and wakefulness. Heart rate variability (HRV) is a variable which is widely used to assess the autonomic regulation of the heart by measuring the changes in the cardiac rhythm through time. Previous research has demonstrated that forced unilateral nostril breathing or specific nostril yogic breathing causes selective stimulation of the contralateral hemisphere, as indicated by alternating lateralization of plasma catecholamines and relative increases in the contralateral hemisphere’s electroencephalogram amplitude. Breathing practice increases the vagal tone of the sinoatrial (SA) and atrioventricular (AV) node and also improves baroreceptor sensitivity, although at a breathing rate of six breaths per minute. HRV has circadian periodicity with significant alterations during the transition from wake to sleep and across sleep cycles. Very few studies are available in the literature that shows the effect of particular pranayama on Heart Rate Variability (HRV) with underlying conditions. So we planned to elucidate the effect of chandranadi pranayama on Heart Rate Variability among primary insomnia, making this research a valuable contribution to the field –A Randomized Controlled Study. |