| CTRI Number |
CTRI/2023/02/049651 [Registered on: 13/02/2023] Trial Registered Prospectively |
| Last Modified On: |
02/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Agnikarma on Lumbar Spondylosis by Suwarna shalaka and Tamra shalaka in pain management |
|
Scientific Title of Study
|
Assessment of comparative efficacy of Agnikarma by Suwarnashalaka versus Tamrashalaka in pain management of Katigatvata (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 Sheetal Asutkar |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research Centre |
| Address |
Room no.13 Department of Shalya Tantra Mahathma Gandhi Ayurveda College and Institute Salod (H) Wardha Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9766811974 |
| Fax |
|
| Email |
sheetalasutkar16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sheetal Asutkar |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research Centre |
| Address |
Room no.13 Department of Shalya Tantra Mahathma Gandhi Ayurveda College and Institute Salod (H) Wardha Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9766811974 |
| Fax |
|
| Email |
sheetalasutkar16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sheetal Asutkar |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research Centre |
| Address |
Room no.13 Department of Shalya Tantra Mahathma Gandhi Ayurveda College and Institute Salod (H) Wardha Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9766811974 |
| Fax |
|
| Email |
sheetalasutkar16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurveda College and Hospital Salod Wardha 442001 Maharashtra |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurveda College and Hospital |
| Address |
Mahatma Gandhi Ayurveda College and Hospital Salod Wardha 442001 Maharashtra
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sheetal Asutkar |
Mahathma Gandhi Ayurveda College Hospital and Research Institute |
room no- 13, Department of Shalya Tantra, Mahathma Gandhi Ayurveda College Hospital and Research Institute Salod Wardha Maharashtra
Wardha
MAHARASHTRA |
9766811974
sheetalasutkar16@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 |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: VATAVYADHIH, |
|
|
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 Samhita Sutrasthan Sdhayay-12 Shloka-4, Procedure details: Patient will lie in prone position over minor OT table. The area of maximum tenderness areas in low back region will be marked by marker pen. Maximum 7-10 points will be marked. After this the part will be cleaned with Betadine. Suvarna shalaka will be heated to red hot over gas stove. Later Agnikarma will be performed with red hot shalaka in bindu akruti at marked points till samyaka dagdha lakshanas i.e. twaksankoch (wrinkling of skin at burn site), shabdapradurbhav (sound of tissue burn) and )
| | 2 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushrut Samhita Sutrasthan Sdhayay-12 Shloka-4, Procedure details: Patient will lie in prone position over minor OT table. The area of maximum tenderness areas in low back region will be marked by marker pen. Maximum 7-10 points will be marked. After this the part will be cleaned with Betadine. Tamra shalaka will be heated to red hot over gas stove. Later Agnikarma will be performed with red hot shalaka in bindu akruti at marked points till samyaka dagdha lakshanas i.e. twaksankoch (wrinkling of skin at burn site), shabdapradurbhav (sound of tissue burn) and tw)
|
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from Kati shool (low back pain).
Patients suffering from lumbar spondylosis.
Patients of either sex between 40 to 60 years.
Willing & able to participate and complete the study.
Selection will be irrespective of gender, religion and other socio-economic status.
|
|
| ExclusionCriteria |
| Details |
Patients suffering from Infective Pathology, Pott’s spine, Fracture, trauma, uncontrolled DM and Metastatic disease of spine. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduced pain, stiffness, tenderness and scar |
at baseline, 7 days, 14 days, and 21 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduced pain, stiffness, tenderness and scar |
30 days, 45 days, 60 days |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/02/2023 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study, Local application of Agnikarma by Suvarna or Tamra shalaka that will be heated to red
hot over gas stove and performed with red hot shalaka
in bindu akruti at marked points till samyaka dagdha lakshanas ,Immediately
after Agnikarma aloe vera pulp will be applied over the site of Agnikarma. The
patient will be advised to rest for half an hour and then sent home. He will be
advised to keep the area dry and clean. It will be given for 21 days. The observations will be made on 7th,
14th and 21st day i.e. on subsequent sittings regarding the changes with the
treatment. Changes in symptoms will be recorded in the proforma of case sheet
prepared for the study . Assessment will be done on the basis of reduced score of Criteria for Pain measurement by visual analogue
scale (VAS), Stiffness, Tenderness, Scar. |