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CTRI Number  CTRI/2024/10/074842 [Registered on: 07/10/2024] Trial Registered Prospectively
Last Modified On: 01/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   EFFECTIVENESS OF AGNIHOTRA AND AGNIHOTRA BHASMA AS SHIROPICHU IN STRESS  
Scientific Title of Study   A CLINICAL STUDY ON ADD-ON EFFECTIVENESS OF AGNIHOTRA AND AGNIHOTRA BHASMA AS SHIROPICHU IN STRESS DISORDER  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ARJUN S 
Designation  PG SCHOLOR 
Affiliation  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA HOSPITAL HASSAN  
Address  SANKALPA,7TH CROSS,BEHIND MILK DAIRY,NEAR MANGLORE PUBLIC SCHOOL, KANCHAMARANAHALLI HASSAN-573219
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA HOSPITAL TANNIRUHALLA HASSAN KARNATAKA 573201
Hassan
KARNATAKA
573219
India 
Phone  8105004491  
Fax    
Email  92sarjun@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Savitha HP 
Designation  Professor , Postgraduate  
Affiliation  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA HOSPITAL HASSAN  
Address  Professor , Postgraduate Department of Manovigyan avum Manasa Roga ,Sri Dharmasthala Manjunatheswara College and Hospital BM Road Thanniruhalla Hassan Karnataka 573201 India
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA HOSPITAL TANNIRUHALLA HASSAN KARNATAKA 573201
Hassan
KARNATAKA
573201
India 
Phone  9980168208  
Fax    
Email  savithem@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Savitha HP 
Designation  Professor , Postgraduate  
Affiliation  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA HOSPITAL HASSAN  
Address  Professor , Postgraduate Department of Manasaroga ,Sri Dhaemasthala Manjunatheshwar College of Ayurveda and Hospital(Rajiv Gandhi University of Health Sciences), Hassan , Karnataka ,India.
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA HOSPITAL TANNIRUHALLA HASSAN KARNATAKA 573201
Hassan
KARNATAKA
573201
India 
Phone  09980168208  
Fax    
Email  savithem@gmail.com  
 
Source of Monetary or Material Support    
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospial Hassan 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospial, BM Road Thanniruhalla, Hassan 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
ARJUN S  SDM COLLEGE OF AYURVEDA AND HOSPITAL TANNIRUHALLA HASSAN  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
ARJUN S  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL  TANNIRUHALLA HASSAN 573201
Hassan
KARNATAKA 
8105004491

92sarjun@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
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:F439||Reaction to severe stress, unspecified. Ayurveda Condition: UNMADA-PURVARUPAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-Agnihotra and agnihotra bhasma shiropichu (Procedure Reference: Rigaveda, Procedure details: AGNIHOTRA 1. Sit Down on the ground/floor facing the sun in a quiet place. 2. Lit a few pieces of cowdung smeared with cow ghee in the copper pot a few minutes before sunset 3. Take around 10gms grains of rice in your left palm smear with a drop of Ghee. 4. Exactly at local time of sunset utter the appropriate mantra and offer a portion of rice twice onto the fire in pot with utterance of each line of the Mantra. 5. Sit quietly in squatting posture for a few minutes as the fire cools down/extinguishes in the pot AGNIHOTRA SHIROPICHU 1. Participant is asked to sit on chair and he /she will be explained about the procedure 2. 25gms of Agnihotra Bhasma is taken and mixed with quantity sufficient warm milk to make semi-solid paste. 3. Agnihotra Bhasma mixed with milk is placed on vertex measuring 4’X4’ cm and in 1 inch thickness. A piece of banana leaf is placed over pichu and tied with cotton gauze and kept for a duration of 60 min in the afternoon. 4. After the stipulated time duration the cotton pad is to be removed, gently wash on applied area. 5.Same procedure need to be carried out for 7days. )
(1) Medicine Name: AGNIHOTRA BHASMA , Reference: RIGVEDA , Route: Topical, Dosage Form: Kalka/ Paste, Dose: 25(g), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age group between 18-60 years
2. Participants of all gender irrespective of socio-economic status
3. Participants ready to sign informed consen 
 
ExclusionCriteria 
Details  1. Participants under psychotropic medication.
2. Participants with acute substance intoxication
3.During menstruation period of female participants.
4. Participants who cannot follow instructions to perform 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction of stress symptoms as measured by galvonic skin response and VAS Scale .  Reduction of stress symptoms as measured by galvonic skin response and VAS Scale . 
 
Secondary Outcome     
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   20/10/2024 
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="0"
Days="0" 
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  

Stress is a significant concern in the modern world, with the World Health Organization declaring it the "Health Epidemic of the 21st Century." It has a profound impact on individuals, leading to physical, emotional, and psychological distress, with medical researchers estimating that 90% of illnesses are stress-related. The causes of stress, known as stressors, affect mood, well-being, behaviour, and health. According to yoga philosophy, stress is rooted as Dukkha (misery) and Klesha (suffering), disrupting inner equilibrium and leading to psychosomatic disorders. Daiva Vyapashraya Chikitsa, an Ayurvedic therapeutic approach, employs techniques like Mani, Mantra, Bali, Homa, Abhyupahara, and Japa for stress relief. Additionally, the practice of Agnihotra, a Vedic ritual involving fire offerings and the byproducts i.e, Agnihotra Bhasma has been linked to positive effects on mental health and may help combat conditions like epilepsy, insomnia, and anxiety. It is a simple procedure, costeffective, feasible with no gender discrimination to perform. A combination therapy of Daiva Vyapashraya Chikitsa and yukthi vyapashraya can benefit in managing the stress disorder. The study aims to assess the impact of Agnihotra and Agnihotra Bhasma Shiropichu on the stress levels by comparing the pretest and post-test results in both control and study groups. This open-label double-arm clinical study will help evaluate the potential benefits of these interventions in managing stress. 

 
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