| CTRI Number |
CTRI/2023/03/051114 [Registered on: 28/03/2023] Trial Registered Prospectively |
| Last Modified On: |
27/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Agnikarma an Ayurvedic Pain Management modality in low back pain |
|
Scientific Title of Study
|
Assessment of Comparative efficacy of Agnikarma by Panchdhatu, Tamra, Lauha, Rajat and Suwarna Shalaka in pain management of Katigatvata w.s.r to Lumbar Spondylosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradnya P Dakhole |
| Designation |
PhD Scholar |
| Affiliation |
Datta Meghe Institute of Higher Education And Research |
| Address |
Room no 13 Dept of Shalya Tantra Mahatma Gandhi Ayurved College Datta Meghe Institute of Higher Education and Research
Room no 13 Dept of Shalya Tantra Mahatma Gandhi Ayurved College Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
INDIA
Wardha
MAHARASHTRA
442001
India |
| Phone |
9860229082 |
| Fax |
|
| Email |
pradnyadakhole1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sheetal Asutkar |
| Designation |
Professor and Head of Dept Shalya Tantra |
| Affiliation |
Datta Meghe Institute of Higher Education And Research |
| Address |
Room no 13 Dept of Shalya Tantra Mahatma Gandhi Ayurved College Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9766811974 |
| Fax |
|
| Email |
sheetalasutkar16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sheetal Asutkar |
| Designation |
Professor and Head of Dept Shalya Tantra |
| Affiliation |
Datta Meghe Institute of Higher Education And Research |
| Address |
Room no 13 Dept of Shalya Tantra Mahatma Gandhi Ayurved College Datta Meghe Institute Of Higher Education and Research
Wardha
Maharashtra
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9766811974 |
| Fax |
|
| Email |
sheetalasutkar16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College hospital and Research Centre Wardha Maharashtra |
|
|
Primary Sponsor
|
| Name |
Dr Pradnya P Dakhole |
| Address |
Flat no 202 Raghav Residency New Manish Nagar Nagpur |
| Type of Sponsor |
Other [Self] |
|
|
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 Pradnya Dakhole |
Mahatma Gandhi Ayurved College Hospital & Research Institute Salod Wardha |
Room no 13 Department of Shalyatantra,Mahatma Gandhi Ayurveda College And Research Institute Salod Wardha
Wardha
MAHARASHTRA |
9860229082
pradnyadakhole1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M47||Spondylosis. Ayurveda Condition: Katigatvata, (2) ICD-10 Condition:M47||Spondylosis. Ayurveda Condition: Katigatvata, |
|
|
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: sushrut sutrasthan 12, Procedure details: the most painful spots are marked in lumbar region. panchdhatu shalaka is heated red hot and agnikarma done at marked points. after agnikarma the aloe vera is applied at the site of agnikarma. )
| | 2 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: sushrut sutrasthan 12, Procedure details: the most painful point in lumbar region is marked. the Tamra shalaka is heated red hot and agnikarma done on marked points.after this the aloe vera is applied on the spots.)
| | 3 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: sushrut sutrasthan 12, Procedure details: the most painful points are marked in lumbar region. lauha shalaka is heated red hot and agnikarma done at the marked points. aloe vera applied at the agnikarma site.)
| | 4 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: sushrut sutrasthan 12, Procedure details: the most painful points are marked in lumbar region. rajat shalaka is heated red hot and agnikarma done at the marked points. aloe vera applied at the agnikarma site.)
| | 5 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: sushrut sutrasthan 12, Procedure details: the most painful points in lumbar region are marked. suwarna shalaka is heated red hot and agnikarma done at marked points. aloe vera applied at agnikarma site)
|
|
|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient suffering from katishool ( low back pain), Lumbar spondylosis willing and able to participate and complete the study |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
pain
stiffness
tenderness
|
0th 7th 14th 21st day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| easy movements and able to do day to day chores |
follow up on 30th 45th 60th day |
|
|
Target Sample Size
|
Total Sample Size="330"
Sample Size from India="330"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
04/04/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a single blind randomized control trial comparing the efficacy of agnikarma by panchadhatu, tamra, lauha , rajat and suwarna shalaka in pain management of katigatvat weekly once for four weeks in 330 patients and the outcome will be measured on assessment scale after completion of treatment duration on 07th day , 15th day, 30th day. |