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CTRI Number  CTRI/2022/09/045574 [Registered on: 15/09/2022] Trial Registered Prospectively
Last Modified On: 22/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effect of Agnihotra Homa And Gayatri Mantra chanting in Post-CoVID-19 anxiety 
Scientific Title of Study   A clinical study of Agnihotra Homa and Gayatri Mantra in Post Covid-19 anxiety 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr AMOL DNYANESHWAR JADHAV 
Designation  1st YEAR POSTGRADUATE SCHOLAR 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital 
Address  Department of Manovigyan Avum Manasaroga Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital, BM Road, Thanniruhalla, Hassan – 573 201, Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9665253960  
Fax    
Email  amolara15@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SAVITHA H P 
Designation  Professor and Head 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital 
Address  Department of Manovigyan Avum Manasaroga Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital, BM Road, Thanniruhalla, Hassan – 573 201, Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9980168208  
Fax    
Email  savithem@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr SAVITHA H P 
Designation  Professor and Head 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital 
Address  Department of Manovigyan Avum Manasaroga Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital, BM Road, Thanniruhalla, Hassan – 573 201, Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9980168208  
Fax    
Email  savithem@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital, BM Road, Thanniruhalla, Hassan – 573 201, Karnataka India College Phone:08172 256460 Email: college@sdmhassan.org 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital, BM Road, Thanniruhalla, Hassan – 573 201, Karnataka  
Type of Sponsor  Private medical college 
 
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 AMOL DNYANESHWAR JADHAV  Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital  Department of Manovigyan Avum Manasaroga OPD NO 8 Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital, BM Road, Thanniruhalla, Hassan – 573 201, Karnataka
Hassan
KARNATAKA 
9665253960

amolara15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda And Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:U071||COVID 19 virus identified. Ayurveda Condition: CITTODVEGA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-homam, होमम् (Procedure Reference: CHARAKA SAMHITA , Procedure details: 1 Agnihotra Homa kunda(Vessel) will be prepared (which is of specific dimension’s- base: 5.25cm x 5.25cm; area at the open end 14.5cm x 14.5cm and height:6.5cm). 2 It will be instructed to all the participants, to complete all the Saucha- vidhi, after proper shudhi all the participants are instructed to sit around the Homa Kunda in Sukhasana (legs folded around) over cotton cloth or jute sheets. 3 After that cow dung cakes are arranged in the vessel along the four sides in a way so as to)
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  a. Subjects in between age of 21– 60 years
b. Post Covid-19 subjects of either gender irrespective of caste, creed, occupation, religion and socioeconomic status
c. Post Covid-19 subjects who are willing to participate and ready to sign the informed consent form
d. Subjects with Mild – Moderate Covid-19 Anxiety, CAS scoring ≥ 9.
 
 
ExclusionCriteria 
Details  a. Subjects with known case of Brain and Spinal cord injury/ surgery.
b. Subjects with Intervertebral disk prolapse, Spondylitis etc.
c. Subjects with known case of Chronic obstructive pulmonary disease (COPD).
d. Subjects who are sensitive to smoke allergens.
e. Menstruating women.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
SYMPTOMS OF COVID ANXIETY   Before treatment on (0 day) and after treatment on 7th day  
 
Secondary Outcome  
Outcome  TimePoints 
COVID ANXIETY SCALE  8TH DAY 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="34" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/09/2022 
Date of Study Completion (India) 31/07/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

     According to WHO, Coronavirus disease COVID-19 (U07.1) is an infectious disease caused by a newly discovered coronavirus. As on 1st July 2021, 181 million cases have been confirmed. among them 3.93 million confirmed deaths1. Because of its high spreading nature and unavailability of proper treatment makes it more fatal. During this pandemic anxiety and distress has increased due to fear of infection and isolation norms2. Stress of it is responsible for production of different anxiety disorders such as Generalized anxiety disorder (GAD), Phobia or Panic-anxiety disorder, Obsessive-compulsive disorder (OCD), Post traumatic stress disorders (PTSD) etc.  Currently Post Covid-19 (U09.9) anxiety is emerging problem in whole medical faculty. Anxiety medications results in dependency, leading to further health deprivation and are economically unaffordable. In such circumstances people are in search of safe, affordable, easily available medication.

     Chittodvega, a Manasika vikara3 can be co-related with anxiety, which is caused by vitiation of Rajas and Tamas and people with Alpa Satva are more prone to it4. Ayurveda has mentioned Daivavyapashraya chikitsa as one among the Trividha Chikitsa for the treatment of  disease whose  the exact cause is  not known, Homa and Mantra are important among them5. Agnihotra Homa refers to any ritual of making offering into a consecrated fire6,7 and Mantra means the Vedic Hymns. They are chanted during the course of Homa vidhi. In Agnihotra homa we are using medicinal herbs that contain many psychotropic volatile oils8. During respiration these medicinal volatile oils enters in the respiratory system through nasal route and directly gets absorbed by nasal mucosa, lung cells in systemic circulation and start their action on body and mind9. In Ayurvedic science, nasal route is the best way to administer medicine in psycho-somatic disorders10. Thus, medicated fumes emitted from Homa acts as anxiolytic. 

     It is scientifically proven that chanting of Mantra facilitates the property and potency of medicinal fumes11. Chanting of ‘Gayatri Mantra’ in rhythmic way activates every cell and enhances natural healing mechanism, by producing positive vibrations in body12. It normalizes the neurotransmitters like GABA, Serotonin, Adrenaline, Dopamine etc. Regular chanting of it creates soothing effect on nervous system, relaxes muscle and reduces stress and anxiety. So, both the ‘Agnihotra Homa’ and ‘Gayatri Mantra’ has been taken as study to manage Post COVID-19 anxiety.

OBJECTIVE OF THE STUDY

To Study the Combined effect of Agnihotra Homa and Gayatri Mantra in Post Covid-19 Anxiety.

 

 STUDY DESIGN:

 

a)    Type of study: Open label Single arm Prospective clinical study

 

b)    Sampling method: Convenience sampling

 

c)    Test: pretest and post test

 

d)    Sample size: 30 subjects

 

e)    Treatment duration: 7 days

 

SOURCE OF DRUG – Agnihotra Homa materials will be obtained from SDM Pharmacy Udupi GMP Certified pharmacy and will be authenticated from Department of Dravyaguna, SDM college of Ayurveda and Hospital, Hassan.

 

B) DIAGNOSTIC CRITERIA–

 

The patients presenting anxiety as major symptom in Post Covid-19 (U09.9) Anxiety disorder, will be subjected to detailed clinical history and physical examination. The following criteria of ICD-10-CM will be taken into consideration to the final diagnosis.

Post covid-19 Anxiety disorder episode is considered when at least two of Physiological arousal domain and minimum of two Autonomic arousal domain with significant sleep disturbance. Grading of symptoms will be done during the clinical study.

A.    Psychological arousal- fearful anticipation, irritability, anger, restlessness

B.    Autonomic arousal- excessive sweating, tachycardia, dyspnea, dry mouth

C.    Sleep disturbance

D.    Subjects fulfilling COVID-19 Anxiety Scale23 (CAS), scoring ≥ 9.

 

C) INCLUSION CRITERIA:

a.     Subjects in between age of 21– 60 years

b.     Post Covid-19 subjects of either gender irrespective of caste, creed, occupation, religion and socioeconomic status

c.     Post Covid-19 subjects who are willing to participate and ready to sign the informed consent form

d.     Subjects with Mild – Moderate Covid-19 Anxiety, CAS scoring ≥ 9.

D) EXCLUSION CRITERIA:

 

a.     Subjects with known case of Brain and Spinal cord injury/ surgery.

b.     Subjects with Intervertebral disk prolapse, Spondylitis etc.

c.     Subjects with known case of Chronic obstructive pulmonary disease (COPD).

d.     Subjects who are sensitive to smoke allergens.

e.     Menstruating women.

 

ASSESMENT CRITERIA:

Subjects will be assessed on 0th day (before treatment) and 8th day (after treatment) Each item of the CAS is rated on a 5-point scale, from 0 (not at all) to 4 (nearly every day), based on experiences over the past two weeks. This scaling format is consistent with the DSM-5’s cross-cutting symptom measure. A CAS total score ≥ 9 indicates probable dysfunctional coronavirus-related anxiety. Elevated scores on a particular item or a high total scale score (≥ 9) may indicate problematic symptoms for the individual that might warrant further assessment and/or treatment. Clinical judgement should guide the interpretation of the CAS results.

 

 

 
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