| CTRI Number |
CTRI/2025/12/098507 [Registered on: 05/12/2025] Trial Registered Prospectively |
| Last Modified On: |
04/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Ayurvedic management of Sciatica. |
|
Scientific Title of Study
|
A Randomized Open Labelled Comparative Clinical Study To Evaluate The Effect Of Modified Agnikarma (Viddhagnikarma) And TENS Therapy In The Management Of Gridhrasi W.S.R To Sciatica. |
| 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 Shanmugapriya T |
| Designation |
Shalyatantra post graduate scholar |
| Affiliation |
Taranath government ayurvedic medical college and hospital ballari |
| Address |
Department of PG studies in Shalyatantra,
Taranath Government Ayurvedic Medical college and hospital, Dr Rajkumar road, Ballary
Bellary
KARNATAKA
583101
India |
| Phone |
7010678836 |
| Fax |
|
| Email |
priyamarasu21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivalingappa J Arakeri |
| Designation |
Professor and Head of department |
| Affiliation |
Taranath government ayurvedic medical college and hospital |
| Address |
Department of PG studies in Shalyatantra,
Taranath Government Ayurvedic Medical college and hospital, Dr Rajkumar road, Ballary
Bellary
KARNATAKA
583101
India |
| Phone |
9845894052 |
| Fax |
|
| Email |
shivu.doc.29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shanmugapriya T |
| Designation |
Shalyatantra post graduate scholar |
| Affiliation |
Taranath government ayurvedic medical college and hospital |
| Address |
Department of PG studies in Shalyatantra,
Taranath Government Ayurvedic Medical college and hospital, Dr Rajkumar road, Ballary
Bellary
KARNATAKA
583101
India |
| Phone |
7010678836 |
| Fax |
|
| Email |
priyamarasu21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of PG studies in Shalyatantra, room no.2, Taranath Government Ayurveda Medical
college and hospital,Dr Rajkumar road, Ballary-583101 |
|
|
Primary Sponsor
|
| Name |
Taranath government ayurvedic medical college and hospital |
| Address |
Taranath government ayurvedic medical college and hospital
ballari,Dr Rajkumar road-583101 |
| Type of Sponsor |
Government 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 Shanmugapriya T |
Taranath government ayurvedic medical college and hospital ballari |
Department of PG studies in Shalyatantra, Room number 2, Taranath government ayurvedic medical college and hospital,
Dr rajkumar road,
ballari.
Bellary
KARNATAKA |
7010678836
priyamarasu21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Taranath Government Ayurvedic Medical College Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M538||Other specified dorsopathies. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Modified Agnikarma(Viddhagnikarma) | (Procedure Reference: Susruta samhita , Procedure details: MODIFIED AGNIKARMA (Viddhagnikarma)
Purvakarma:
Informed & written consent taken.
Patient was advised to take pichchila anna before procedure.
Pradhanakarma:
The Patient will be advised to lie down in prone position.
With gentle palpation along the course of sciatic nerve, most tender areas are elicited & marked.
The 26 Gauge sterile needles will be pricked at the depth of 1mm - 3mm at marked tender points with uniform distance of 1cm length & width.
Diathermy cautery will be gently touched to the needles.
Total 3 rounds of Agnikarma will be done.
Paschatkarma:
After that the needles will be removed followed by application of Madhu & Sarpi.
Likewise, 3 sittings will be done with the interval of 1 week.
)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Transcutaneous Electrical Nerve Stimulation (TENS therapy) | Purvakarma:
Informed and written consent taken.
Pradhanakarma:
Patient will be advised to lie down in prone position. With gentle palpation along the course of sciatic nerve, most tender areas are elicited.
Electrodes are placed with the frequency of 50Hz, continuous pulse width and intensity based on the patient tolerence capacity.Procedure will last for 15min.
Paschatkarma:
After that electrodes are removed, parts cleaned with saline soaked gauze. Procedure shoud be continued daily for 21 days.
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient who has signed informed consent form.
2.Pratyatma lakshanas of Gridhrasi like Ruk (Pain), Stambha (Stiffness),Gourava (Heaviness),Suptatha(Numbness)and (Sakthi Utksepa Nigrahana) positive SLR test. |
|
| ExclusionCriteria |
| Details |
1.Spinefracture, Caudaequina syndrome, Spina bifida, Sacro-iliac joint dislocation and Sacroiliitis.
2.Pregnancy and Lactative women.
3.Sciatica due to secondary causes such as Spinetumor and TB of spine.
4.Patients suffering from other systemic illness like uncontrolled DM, HTN and infection of spine by Herpes simplex virus.
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from subjective and objective parameters. |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Prevention of sciatica complications
Improve quality of life |
1 month |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/12/2025 |
| 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="0"
Days="21" |
|
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
|
Study entitled as A RANDOMIZED OPEN LABELLED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF MODIFIED AGNIKARMA (VIDDHAGNIKARMA) AND TENS THERAPY IN THE MANAGEMENT OF GRIDHRASI W.S.R TO SCIATICA is done in the Taranath government ayurvedic medical college and hospital Ballari in two groups and are compared for better outcome of results.
OBJECTIVES OF THE STUDY - To evaluate the effect of Modified Agnikarma (Viddhagnikarma) in the management of Gridhrasi w.s.r to Sciatica.
- To evaluate the effect of TENS therapy in the management of Gridhrasi w.s.r to Sciatica.
- To compare the effect of Modified Agnikarma (Viddhagnikarma) and TENS therapy in the management of Gridhrasi w.s.r to Sciatica.
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