| CTRI Number |
CTRI/2024/12/077573 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of MSRT (Mind Sound Resonance Technique) and Yoga Nidra in Mixed Depressive Anxiety Disorder (MDAD) |
|
Scientific Title of Study
|
Effect of MSRT (Mind Sound Resonance Technique) and Yoga Nidra on Heart Rate Variability and Oxidative Stress Markers in Mixed Depressive Anxiety Disorder (MDAD) - A Randomized Control Clinical Trial |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mayank Vishwakarma |
| Designation |
Ph.D Scholar |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University, Uttar Pradesh-221005. |
| Address |
Department of Kayachikitsa, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Uttar Pradesh-221005.
Department of Kayachikitsa, Faculty of Ayurveda
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8770051968 |
| Fax |
|
| Email |
mayankvishwakarma68@bhu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Jyoti Shanker Tripathi |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University, Uttar Pradesh-221005. |
| Address |
Department of Kayachikitsa, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Uttar Pradesh-221005.
Department of Kayachikitsa, Faculty of Ayurveda
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9838706393 |
| Fax |
|
| Email |
drjstripathi@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mayank Vishwakarma |
| Designation |
Ph.D Scholar |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University, Uttar Pradesh-221005. |
| Address |
Department of Kayachikitsa, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Uttar Pradesh-221005.
Department of Kayachikitsa, Faculty of Ayurveda
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8770051968 |
| Fax |
|
| Email |
mayankvishwakarma68@bhu.ac.in |
|
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Source of Monetary or Material Support
|
| (UGC NET JRF Scholarship for PhD Scholars)Sir Sunderlal Hospital Kayachikitsa OPD Number 23 Indian Medicine Wing Banaras Hindu University Varanasi Uttar Pradesh 221005 (India) |
|
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Primary Sponsor
|
| Name |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Department of Kayachikitsa faculty of Ayurveda, Institute of Medical Sciences Banaras Hindu University 221005 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Jyoti Shanker Tripathi |
Institute of Medical Sciences Banaras Hindu University |
OPD AND IPD of Psychosomatic Medicines and Neuro psychiatry section, Department of Kayachikitsa, faculty of Ayurveda, IMS, BHU, 221005
Varanasi
UTTAR PRADESH |
9838706393
drjstripathi@rediffmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Medical Medical Sciences, Banaras Hindu University |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F413||Other mixed anxiety disorders, (2) ICD-10 Condition: F413||Other mixed anxiety disorders, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ayurvedic Medication group |
subjects of this group will be given medication (Sharaswat Churna five gram daily twice a day) for 3 months |
| Intervention |
Mind Sound Resonance Technique (MSRT) with Ayurvedic medication. |
MSRT is one of the advanced yoga techniques for achieving deep relaxation, which is developed by SVYASA, Bengaluru, Karnataka (Swami Vivekanand yoga samsthan). MSRT involves experiencing with closed eyes the internal vibrations and resonance developed while chanting the syllables A, U, M, Om and Mahamrityunjaya mantra sounds. Instructions will be given in the recorded tape to feel the resonance all over the body both during loud (Ahata: heard) and mental chanting (Anahata: unheard). This is done alternately starting from Ahata ‘A’ followed by Anahata ‘A’ repeated three times. This is followed by similar repetitions of all other chants. Resonance generated by MSRT helps in revitalizing the internal energy in the body.
(Intervention will be given daily 30 Minutes for 12 weeks or 3 months.) |
| Intervention |
Yoga Nidra with Ayurvedic medication |
Yoga Nidra is a deep relaxation technique. We will use the Yoga Nidra Level - 2 intervention, developed by Swami Satyananda Saraswati, School of Yoga, Munger, Bihar, India.
The Yoga Nidra recording will be made using scripts from Swami Satyananda Saraswati’s Yoga Nidra book.
(Intervention will be given daily 30 Minutes for 12 weeks or 3 months.) |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Eighteen (20) to sixty (60) years of age.
Patients to have met the ICD 11 diagnostic criteria for MDAD (will be assessed by the referring clinician).
Sex – male and female.
Patients who will be able to understand the instruction in Hindi or English language.
Willingness to participate in the trial.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria (Hypertension, renal, endocrine, cardiovascular and respiratory disorders are known to affect autonomic system of the body in many ways; that’s why these were chosen as exclusion criteria).
Patients with hypertension
Any history of blood transfusion within 3 months.
Patients with renal and endocrine disorders
Patients with cardiovascular disorders
Patients with respiratory disorders or any other chronic disease.
Sleeping pills (masking of intervention effects)
Cannabis within 30 d (masking intervention effects)
Smoke cigarettes and alcoholism (interference with relaxation and may influence cognitive functions and sensory and motor variables) |
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| to compare the impact of MSRT and Yoga Nidra on Anxiety, And Depression in Mixed Depressive Anxiety disorder. |
outcome will be assessed at baseline, 6 weeks and 12 weeks |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
to evaluate the impact of MSRT
and Yoga Nidra on biochemical & inflammatory markers related to oxidative stress among the subject of Mixed Depressive Anxiety disorder. |
Biochemical assessments will be conducted at two time points: baseline of trial initiation & 12 week trial completion. |
| to evaluate the effect of MSRT & Yoga Nidra on Heart Rate Variability in patients with Mixed Depressive Anxiety disorder. |
outcome will be assessed at baseline, 6 weeks & 12 weeks |
|
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Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 |
|
Date of First Enrollment (India)
|
11/12/2024 |
| 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="2"
Months="0"
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
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Brief Summary
|
Mixed depressive and anxiety disorder (MDAD) is
characterized by symptoms of both anxiety and depression more days than not for
a period of two weeks or more. Yoga is a powerful tool for
managing anxiety and depression, with significant positive effects on HRV by
promoting a balanced autonomic nervous system, enhancing parasympathetic
activity, and reducing stress, yoga can improve overall mental health and
well-being.
High HRV is generally
associated with good health and a well-functioning stress response system,
while low HRV is linked to stress, anxiety, depression, and other health
issues. Yoga can play a significant role in managing anxiety and depression by
positively influencing HRV.
Yoga mantras and prayers
have been found beneficial for many physiological and psychological functions
of the body.(Bernardi et al., 2001). A study conducted by (Amin et al., 2016) found Om chanting has beneficial
effects on depression, anxiety and stress scores.
another study validates the
effectiveness of Om chanting and Yoga Nidra in reducing depression, anxiety,
stress and improving sleep quality and autonomic functions in hypertensive
patients.(Rajagopalan et al., 2023a)
This study has the potential to enhance
evidence-based interventions for individuals experiencing depression and
anxiety. We will investigate how
MSRT and Yoga Nidra affect psychophysiological factors alongside biochemical
measurements.
Additionally,
there is no report of an earlier comparative study on the efficacy of MSRT and Yoga
Nidra on Anxiety and Depression so far. Although, many good RCT studies on
Depression and Anxiety have been done where Om chanting and Yoga Nidra was
reported to be more efficacious.
So, considering all, the
proposed study admits to correcting the limitations of previous studies by
evaluating the effect of Yoga Nidra and MSRT on Heart Rate Variability, Oxidative Stress
Markers, Depression and Anxiety. AIM OF THE STUDY: The present study aims to assess the effects of MSRT
(Mind Sound Resonance Technique – A Yoga-Based Relaxation Technique) and Yoga
Nidra on Heart Rate Variability, Oxidative Stress, Anxiety and Depression and compare
with control group.Objective of the study: - i
to evaluate the effect of
MSRT and Yoga Nidra on Heart Rate Variability in patients with Mixed Depressive
Anxiety disorder.
ii to evaluate the impact of MSRT
and Yoga Nidra on biochemical and inflammatory markers related to oxidative
stress among the subject of Mixed Depressive Anxiety disorder.
iii
to compare the impact of
MSRT and Yoga Nidra on Anxiety, And Depression in Mixed Depressive Anxiety
disorder.
|