| CTRI Number |
CTRI/2026/01/102424 [Registered on: 29/01/2026] Trial Registered Prospectively |
| Last Modified On: |
28/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate effect of heat therapy using ghee vs panchaloha rod in the management of lumbar radiculopathy |
|
Scientific Title of Study
|
Comparative Analysis Of Agnikarma Using Ghrita And Panchaloha Shalaka In The Management Of Ghridrasi Lumbar 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 |
Dr Nikita Devaraddi |
| Designation |
Post Graduate Scholor |
| Affiliation |
Sdm College Of Ayurveda, And Research Centre, Kuthpady Udupi |
| Address |
Sdm College Of Ayurveda, And Research Centre, Kuthpady Udupi
Department Of Shalya Tantra
Opd 5
Udupi
KARNATAKA
574118
India |
| Phone |
9916045165 |
| Fax |
|
| Email |
reddynikita2222@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sahana Kamath |
| Designation |
Assistant Professor |
| Affiliation |
Sdm College Of Ayurveda And Research Centre Kuthpady Udupi |
| Address |
Sdm College Of Ayurveda And Research Centre Kuthpady Udupi
Department Of Shalyatantra
Opd 5
Udupi
KARNATAKA
574118
India |
| Phone |
9844838773 |
| Fax |
|
| Email |
kamathsahanak@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sahana Kamath |
| Designation |
Assistant Professor |
| Affiliation |
Sdm College Of Ayurveda And Research Centre Kuthpady Udupi |
| Address |
SDM College Of Ayurveda And Research Centre Kuthpady Udupi
Department Of Shalyatantra
Opd 5
Udupi
KARNATAKA
574118
India |
| Phone |
9844838773 |
| Fax |
|
| Email |
kamathsahanak@ymail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Nikita Devaraddi |
| Address |
Sri Dharmasthala Manjunatheshwar College Of Ayurveda Hospital And Research Centre |
| Type of Sponsor |
Private medical college |
|
|
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 Nikita Devaraddi |
Sdm College Of Ayurveda And Research Centre Kuthpady Udupi |
Opd 5
Department Of SHalyatantra
Udupi
KARNATAKA |
9916045165
reddynikita2222@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC SDM COLLEGE OF AYURVEDA kuthpady ,udupi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushruta Samhita, Procedure details: In Group B Comparator Group
Agnikarma Done With The Help Of Panchaloha Shalaka Procedure
Patient In A Supine Position The Affected Leg Is Selected For Agnikarma Part Painted With The Betadine Wiped Off Panchaloha Shalaka Is Heated Red Hot 2 Dots Are Kept On The Lateral Aspect Of Little Toe
)
| | 2 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushruta Samhita, Procedure details: Agnikarma Done On 20 Cases Using Ghrita
Procedure
Patient In A Supine Position The Affected Leg Is Selected For Agnikarma Part Painted With Betadine & Wiped Off With Gauze Ghrita Is Heated Approximately 50 Degree & With The Help Of Dropper 2 Drops are Dropped On The Little Toe Lateral Aspect Soon After That It is Wiped Off With Yastimadhu Ghrita)
|
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with pratyatma laxanas of ghridhrasi pain over the sphik, kati, prushta, uru, janu, jangha, extending upto the pada
2. Patients with SLR(straight leg raising test)positive between 30 and 70
3. Subjects presenting with the clinical features of lumbar radiculopathy
4. Subjects of the age group between 30 to 70 years
5. Subjects with the chronicity less than 5 years |
|
| ExclusionCriteria |
| Details |
Subjects with neoplastic, congenital and traumatic conditions of spine
2. Subjects with deep vein thrombosis, cellulitis, ulcer, thrombocytopenic purpura
3. Subjects with uncontrolled diabetic mellitus and hypertension
4. Pregnant woman. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.PAIN
2.NUMBNESS
3.STIFFNESS |
Observation Will Be Done On 1st Day After Procedure of 1st Sitting 8th Day After Procedure Of 2nd Sitting |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Analyse The Efficacy Of Agnikarma Using Ghrita And Panchaloha Shalaka In The Management Of Gridharasi |
8 DAYS |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
09/02/2026 |
| 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="1"
Months="2"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
In reference to lumbar radiculopathy treatment; medical science has only symptomatic management with analgesic like non-steroidal anti-inflammatory drugs and corticosteroids. Possible side effects of NSAIDs include: indigestion stomach ulcers headaches drowsiness dizziness allergic reactions. In some cases if nerve compression is more; surgical procedures like laminectomy, discectomy is indicated but these surgical procedures are expensive with their limitations.
In today’s era quick pain relief is of prime importance to resume normal activities. Hence Agnikarma is considered as instant healers of pain. Agnikarma has been proved to be effective in Ruja Pradhaan Vata vyadhis. Sushruta has mentioned Agnikarma as Para-surgical procedures in Ghridhrasi as superior to other treatment modalities. Acharya Sushruta has told Snighda Agnikarma in sira snayu asthi sandhi .Agnikarma is to be done on the little toe. Hence to evaluate the efficacy of ghrita and panchaloha shalaka in the management gridhrasi (Lumbar radiculopathy) |