| CTRI Number |
CTRI/2021/05/033793 [Registered on: 25/05/2021] Trial Registered Prospectively |
| Last Modified On: |
16/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Online Yoga for Managing Covid-19 Induced Psychological Problems |
|
Scientific Title of Study
|
Online Yoga Intervention as Tertiary Prevention of Psychological Comorbidities of Covid-19 Survivors |
| Trial Acronym |
OYITPPCCOVID |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rudra Bhandari |
| Designation |
Assistant Professor |
| Affiliation |
University of Patanjali |
| Address |
University of Patanjali,
Department of Yoga Science,
Sadbhavana Building
Patanjali Yogpeeth
Phase-1,Haridwar
University of Patanjali,
Department of Yoga Science,
Sadbhavana Building
Patanjali Yogpeeth
Phas1,Haridwar,Uttarakhand,249405.
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9634510540 |
| Fax |
|
| Email |
rbap@uop.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rudra Bhandari |
| Designation |
Assistant Professor |
| Affiliation |
University of Patanjali |
| Address |
University of Patanjali,
Department of Yoga Science
Sadbhavana Building
Patanjali Yogpeeth
Phase-1,Haridwar
University of Patanjali,
Department of Yoga Science
Sadbhavana Building
Patanjali Yogpeeth
Phas1,Haridwar,Uttarakhand,249405.
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9634510540 |
| Fax |
|
| Email |
rbap@uop.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Velan |
| Designation |
JRF |
| Affiliation |
University of Patanjali |
| Address |
University of Patanjali,
Department of Yoga Science
Room No: 421, Patanjali Ayurved College
Patanjali Yogpeeth
Phase-1, Haridwar
University of Patanjali,
Department of Yoga Science
Room No: 421, Patanjali Ayurved College
Patanjali Yogpeeth
Phas-1, Haridwar,Uttarakhand
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9094525759 |
| Fax |
|
| Email |
yogaforcovid@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Science and Technology, MoST, Govt. of India |
|
|
Primary Sponsor
|
| Name |
Patnajli Ayurved Hospital |
| Address |
Sadbhavana Building, Patanjali Yogpeeth-1, Haridwar-249405 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Rudra Bhandari |
Patanjali Ayurved Hospital, AIIMS Rishikesh and Relevant Covid Hospitals of India |
Patanjali Ayurved Hospital
Department of Kayachikitsa
Room No.: 421, Patanjali Yogpeeth Phase-1, Haridwar
Department of Psychiatry, AIIMS Rishkesh, Birbhadra Road, Rishikesh
Hardwar
UTTARANCHAL |
9634510540
rbap@uop.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F063||Mood disorder due to known physiological condition. Ayurveda Condition: MANOVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
22 participants will be given no input for one-month. They will be provided video recordings of Online Yoga Intervention after taking post data. |
| Intervention |
Online Yoga Intervention |
22 participants are expected to go through one-month online yoga classes (5 classes/week) by covering the yogic practices as mentioned in yoga protocol.
Asanas
Loosening and Energing Series (LES):Toes stretch, ankle stretch, ankle rotation, knee stretches, knee rotation, half butterfly, hip joint stretch and rotation, semi spinal twists with extended legs, fingers stretches from middle and distal phalangeal joints, palm stretches, wrist stretches and rotations, shoulder stretches and rotations, neck movements: up-down, sidewise- tilts and twists, rotation, chest opening, spinal stretch, hands rotation from shoulders, facial movements- protraction, retraction, clinching, grinding teeth
Pranamasana(Prayers pose)
Tadasana (Palm Tree Pose)
Padhastasana (Head to Toe Pose), Ustrasana (Camal Pose)
Utkatasana (Chair pose)
Yogmudrasana(Rabbit pose with hands extended back with interlocked fingers)
Ardhatadasana(Semi Palm Tree Pose)
Bhujangasana (Cobra pose)
Shalabhasana (Locust pose)
Vakrasana(Seated Semi Spinal Twist)
Vajrasana (Thunderbolt pose)
Makarasana (Crocodile Pose)
Note: Practice of the aforesaid poses will be synchronized with breathing patterns and mental awareness by caring patients comfort limits.
Breathing practices
Uni-nostril Breathing (UNB)
Alternate Nostril Breathing (ANB)
Kapalbhati
Bhastrika
Kapol Shakti Vikasak(KSV) (Crown Breathing)
Ujjayai.
Bhramari
Mudras: Gyan, Sanmukhi, Prana, and Apana.
Bandhas: Mool, Jalandhar, and Uddiyan
Note: Breathing practices will be synchronized with specified Mudras and Bandhas.
Savita Dhyan (meditation of rising sun).
Attmabodha and Tattwabodh.
Nadyog- Durga Rag and Prayer
|
| Intervention |
Yoga cum Herbal Concoction |
22 Participants are expected to go through online yoga intervention (5 classes/week) along with intake 150 ml of one-time concoction preferably in morning in empty stomach for one month. The concoction will be given for all seven days of the week.
Herbal Concoction will be prepared from Withania Somnifera (Ashwagandha)
Tinospora Cordifolia (Guduchi)
Ocimum Tenuiflorum (Tulsi)
Glycyrrhiza Glabra (Mulathi)
Zingiber Officinale (Ginger)
Piper Nigrum (Black Pepper)
Vitis Vinifera (Raisins)
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)An email address, an internet-connected computer with camera and sound system/ tablet or 4G and/or Wi-Fi enabled Smartphone (running Google chrome).
2)Symptomatic medical history of at least 2 month back and BDI Score≥10 or Hamilton Anxiety Scale Score greater than or equal to 17.
3)Faith on mind body practices and Ayurveda, no involvement in other exercises and interest for voluntary participation in the study.
|
|
| ExclusionCriteria |
| Details |
Participants with medical health issues as under before the onset of clinical symptoms of Covid-19 infection:
Neurological, hypertension, diabetes mellitus, Cardiovascular disease, renal complications, liver disorders, locomotors disabilities, glaucoma, hernia, ulcers of the stomach or intestine, recent abdominal or spinal surgery, pregnancy/lactating phase, addictive behaviors (smoking, alcoholism, tobacco chewing) and age below 15 and above 60 years. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Proposed OYI with and without herbal concoction is expected to improve the PTSD, Anxiety, Depression and Quality of Life of COVID-19 survivors in Experimental groups as compared to the controls.
2)If this OYI protocol proves to be effective, then it may be a good option for over millions global COVID-19 survivors to overcome comorbidities, boost immunity and restore health.
|
Staff Recruitment & training: 01-15 July 2021
Recruitment of Participants, Randomization: 15 July- 15 August 2021
Baseline scoring of instruments: 15-30 August 2021 (4 weeks)
Final scoring of instruments after intervention: 01-05 September 2021 (one week)
Data Entry and Analysis: 15-30 September 2021
Compilation of annual report: October-November 2021
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Anxiety, Post Traumatic Stress Disorder and Quality of Life
|
Baseline and Post Intervention Measurement of Secondary Outcome Variables will be completed in 4 weeks and one week respectively |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2021 |
| Date of Study Completion (India) |
06/03/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
06/03/2022 |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
To be published in PubMed indexed journal/s
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background Covid-19 Survivors are often found with psychological comorbidities such as depression, anxiety, traumatic disorder (PTSD), and poor quality of life (QoL). Online integral yoga intervention including yoga poses, breath regulations, seals, meditation and concoction of the selected medicinal herbs as tertiary prevention of Covid-19 Survivors may be safe, cost effective, and harmless option to manage psychological comorbidities of Covid-19 survivors. Objectives To assess the effect of 1-month Online Yoga Intervention with and without herbal concoction on selected depression, anxiety, post traumatic disorder and quality of life of Covid-19 survivors. Study Design Three armed RCT with 22 clinically significant depressive/anxious Covid-19 survivors to each control, yoga and yoga cum concoction group. Covid-19 survivors aged from 15-60 years and SARS-Cov.2 infection induced clinically significant depression/anxiety and faith on yoga and ayurveda will be included. Those with severe prior health complications and infidelity to yoga and ayruveda will be excluded. Measures Beck Depression Inventory, Hamilton Anxiety Scale, Davidson Trauma Scale and WHO brief version of Quality Life Questionnaire will be used to measure baseline and after intervention depression, anxiety, PTSD and QOL of the participants. Procedures and Protocol After going through PIS and signing informed consent, the participants’ meeting IC will be shortlisted and randomized in three groups CG, YG and YCG for baseline data generation. Then, the participants of YG are expected to go through one-month online yoga classes (5 classes/week) by covering the yogic practices as mentioned in yoga protocol. The participants of YCG are expected to go through online yoga classes (5 classes/week) along with intake 150 ml of one-time concoction preferably in morning in empty stomach for one month. The intake of concoction will continue for one month without any break. Zoom App will be used as an interface for OYI. The procedure and precautions of concoction preparation will be detailed in online or offline meetings after baseline measurements. The said yoga protocol and concoction are harmless and claimed to moderate psychological comorbidities and recurrence of the infection in Covid-19 survivors. However, in case of special physical deformity/ disease, we would consult you in person and assist for needful care. After completion of one month intervention, post data will be generated and the control group participants will be provided online video recordings related to online yoga intervention for their afterhand self-practice if desired. Data Analysis Repeated Measure ANOVAs with post hoc analyses will be performed by using 24th version of IBM SPSS. Expected Outcomes Proposed OYI with and without herbal concoction is expected to improve Covid-19 induced depression, anxiety, PTSD and poor QoL among Covid-19 survivors as safe, inexpensive, and harmless option.
|