| CTRI Number |
CTRI/2026/01/102447 [Registered on: 29/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [ Comparison of two parasurgical procedures] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Comparative study to assess the role of shringavacharana and agnikarma in relieving low back pain radiating to the legs in adults aged 30 to 70 years. |
|
Scientific Title of Study
|
A Comparative study to evaluate the effect of Shringavacharana with Agnikarma in Lumbo sacral Radiculopathy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ARYADAS K K |
| Designation |
PG SCHOLAR |
| Affiliation |
P.N.N.M . AYURVEDA COLLEGE AND HOSPITAL, CHERUTHURUTHY |
| Address |
DEPARTMENT OF SHALYATANTRA P.N.N.M. AYURVEDA MEDICAL COLLEGE AND HOSPITAL, CHERUTHURUTHY, SHORNUR
Thrissur
KERALA
679531
India
Thrissur
KERALA
679531
India |
| Phone |
8089437783 |
| Fax |
|
| Email |
aryadas9946453220@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHAJI K |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
P.N.N.M. AYURVEDA COLLEGE AND HOSPITAL, CHERUTHURUTHY HOSPITAL, CHERUTHURUTHY |
| Address |
DEPARTMENT OF SHALYATANTRA P.N.N.M. AYURVEDA MEDICAL COLLEGE AND HOSPITAL CHERUTHURUTHY
Thrissur
KERALA
679531
India
Thrissur
KERALA
679531
India |
| Phone |
9567889520 |
| Fax |
|
| Email |
shaji.k86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ARYADAS K K |
| Designation |
PG SCHOLAR |
| Affiliation |
P.N.N.M. AYURVEDA COLLEGE AND HOSPITAL, CHERUTHURUTHY |
| Address |
DEPARTMENT OF SHALYATANTRA
P.N.N.M. AYURVEDA MEDICAL COLLEGE AND HOSPITAL, CHERUTHURUTHY
Thrissur
KERALA
679531
India
Thrissur
KERALA
679531
India |
| Phone |
8089437783 |
| Fax |
|
| Email |
aryadas9946453220@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ARYADAS K K |
| Address |
P.N.N.M AYURVEDA MEDICAL COLLEGE AND HOSPITAL, CHERUTHURUTHY, SHORNUR, THRISSUR, KERALA, INDIA, 679531 |
| 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 SHAJI K |
PNNM AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF SHALYATANTRA PNNM AYURVEDA MEDICAL COLLEGE AND HOSPITAL CHERUTHURUTHY
SHORNUR
Thrissur
KERALA
679531
India
Thrissur
KERALA |
9567889520
shaji.k86@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE P.N.N.M. AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Shringavacharana | (Procedure Reference: Ashtanga Hridaya and Susrutha Samhitha, Procedure details: The area for the shringavacharana will be cleaned with antiseptic solution & draped.Shringa attached with suction apparatus will put in the place to mark the area. Suction will be released after 2 minutes. Around 15-20 cutaneous incisions will be made over the area.Shringa attached with suction apparatus will be placed over the area(25 to 30 mm/hg pressure will be maintained). After 3 to 5 minutes suction will be released. Blood will be collected in a kidney tray. The area will be cleaned, dressed & observed for hemostasis.)
| | 2 | Comparator Arm | Procedure | - | Agnikarma | (Procedure Reference: Ashtanga Hridaya and Susrutha Samhitha, Procedure details: The area for the Agnikarma will be cleaned with antiseptic solution & draped. Panchaloha shalaka will be kept over the stove & made red hot. The most tender points will be determined & marked. Agnikarma will be performed over the marked area. After 3 to 4 seconds a cotton smeared in murivenna will be placed over the area after the procedure.)
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age group of 30 to 70 years irrespective of gender
Diagnosed participants of lumbosacral radiculopathy
Spondylolisthesis
Spondylolysis
Scoliosis
Disc Herniation
Participants willing to give written informed consent
|
|
| ExclusionCriteria |
| Details |
History of spinal cord trauma
Spinal stenosis
Infection
Surgery
Contraindicated cases of raktamoksham and agnikarma
Bleeding disorders and Autoimmune neurologic disorders
Systemic and Psychiatric illness
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Immediate pain relief in diagnosed cases of lumbosacral radiculopathy |
At Base line, First day and Third day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
08/02/2026 |
| 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="27"
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
|
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Brief Summary
|
Lumbosacral radiculopathy is a commmon cause of radiating low back pain. This study aims to compare the immediate pain relieving effects of shringavacharana and agnikarma and to assess the difference in their efficacy in pain management.
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