| 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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | 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 |
|
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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. |