| CTRI Number |
CTRI/2024/10/075468 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
11/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Development of Electronically Controlled Devices for Agnikarma
|
|
Scientific Title of Study
|
Conceptualisation of Ideology and Development of Electronically Controlled Devices for Agnikarma along with Optimisation & Aggrandisement
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Sanjay Srivastava |
| Designation |
Ph.D Scholar |
| Affiliation |
Dr. S.R. Rajasthan Ayurved University, Jodhpur |
| Address |
Room No.162, Bharadwaj Bhawan, PGIA, DSRRAU, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9414410383 |
| Fax |
|
| Email |
sanjayphyayu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sanjay Srivastava |
| Designation |
Ph.D Scholar |
| Affiliation |
Dr. S.R. Rajasthan Ayurved University, Jodhpur |
| Address |
Room No.162, Bharadwaj Bhawan, PGIA, DSRRAU, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
09414410383 |
| Fax |
|
| Email |
sanjayphyayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Vishnu Dutt Sharma |
| Designation |
Associate Professor |
| Affiliation |
Dr. S.R. Rajasthan Ayurved University, Jodhpur |
| Address |
Room No.164, Bharadwaj Bhawan, PGIA, DSRRAU, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7742042974 |
| Fax |
|
| Email |
ayurvishnu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Electrical Engineering,
Indian Institute of Technology Jodhpur,
NH 62, Nagaur Road,
Karwar 342037
Jodhpur |
|
|
Primary Sponsor
|
| Name |
DR S R Rajasthan Ayurved University Jodhpur |
| Address |
DR SR Rajasthan Ayurved University Jodhpur-342037 |
| Type of Sponsor |
Research institution and hospital |
|
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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 |
| Dr sanjay srivastava |
Sanjeevani Ayurveda Hospital DSRRAU JODHPUR |
OPD Block, ROOM NO,14
Jodhpur
RAJASTHAN |
09414410383
sanjayphyayu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UPGIAS&R Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: VATAJASULAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushruta Samhita, Procedure details: Once in a day for less than 1 minute for seven days)
|
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• Patients with conditions traditionally treated by Agnikarma, such as joint pain, arthritis, sciatica, muscular spasms.
• Individuals with chronic pain unresponsive to other therapies, suitable for heat-based treatments.
• Participants aged between 18 to 65 years.
• Patients with stable conditions like diabetes or hypertension, without severe heat sensitivity or skin disorders.
• Individuals who provide informed consent and agree to follow-up assessments.
• Patients willing to undergo Agnikarma with electronically controlled devices.
• Ayurvedic practitioners trained in traditional Agnikarma, willing to adopt electronically controlled methods.
|
|
| ExclusionCriteria |
| Details |
• Patients with severe skin conditions, burns, infections, or heat intolerance.
• Pregnant or lactating women due to potential risks.
• Patients with uncontrolled chronic illnesses like cardiac disease, advanced diabetes, or those with compromised immune systems; individuals on anticoagulant therapy.
• Subjects with severe psychiatric disorders or cognitive impairments affecting consent or protocol adherence.
• Individuals with a history of adverse reactions to Agnikarma.
• Patients unwilling to participate in electronically controlled Agnikarma or follow research protocols.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Data generation on Effectiveness and safety of electronically controlled Agnikarma Device |
Weekly |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
o Assess the time efficiency, ease of use, and consistency of electronically controlled Agnikarma devices versus traditional methods.
o Conduct a cost-benefit analysis to determine if the new technology offers improved outcomes and value over time.
o Measure practitioner acceptance and ease of integrating electronic devices into clinical practice.
o Monitor long-term patient outcomes to evaluate sustained therapeutic benefits and recurrence rates compared to traditional Agnikarma.
|
6 Months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
29/10/2024 |
| 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="0"
Months="6"
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
|
|
Brief Summary
|
Agnikarma is one and best among the Anu shastra and para-surgical procedure mentioned in various Ayurvedic texts. And is known for the last option in the disease which are not cured by herbal medicines, surgical intervention and Kshara (alkali).
In Ayurveda, different Acharyas defined and explained broadly about Agnikarma. Acharya Charaka,Sushruta and Vagbhatta explained different types, mode of application and procedure. Acharya Sushruta described in Sushruta Samhita, Sutra sthana in chapter Agnikarma is best among the variously explained therapeutic measures as Agnikarma, Shastra karma and Kshara karma. Agnikarma is best as: 1. There is no recurrence of diseases. 2. Cures the disease completely from base.
3. The disease which are not cured by other measures can be cured.
We hypothesise that the Agni Karma procedure can be made at least twice as faster, more accurate, efficient & cost effective using our device rather than traditional methods of applying Agni Karma. There is also a possibility of reaching to a broader scope of work than just pain relief and the device can be targeted to cure various other ailments which work on the principle of cauterisation. Single-Arm Study:
- This design can be used in the early stages to assess the efficacy, safety, and precision of electronically controlled Agnikarma. All patients undergo the new device-based treatment, and their outcomes are evaluated without comparison to another group.
|