| CTRI Number |
CTRI/2024/12/077950 [Registered on: 11/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Relief Of Sciatica: A Comparison Study Of Lumbar Traction With And Without Agnikarma |
|
Scientific Title of Study
|
Comparative Clinical Study Of Efficacy Of Lumbar Traction With Agnikarma And Lumbar Traction In Management Of Grudhrasi With Reference 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 Vikas Udaybhan Gupta |
| Designation |
M.S. Scholar Shalyatantra Samanya Departmen |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya |
| Address |
Department of Shalyatantra Samanya, Shree Saptashrungi Ayurved
Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik,
Maharashtra 422003
India
Nashik
MAHARASHTRA
422003
India |
| Phone |
8652013989 |
| Fax |
|
| Email |
gvikasg197@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Raut |
| Designation |
H.O.D. |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya |
| Address |
Department of Shalyatantra Samanya,Shree Saptashrungi Ayurved
Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik,
Maharashtra 422003 India
Nashik
MAHARASHTRA
422003
India |
| Phone |
9822979769 |
| Fax |
|
| Email |
dr.aparnaraut12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikas Udaybhan Gupta |
| Designation |
M.S. Scholar Shalyatantra Samanya Department |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya |
| Address |
Department of Shalyatantra Samanya, Shree Saptashrungi Ayurved
Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik,
Maharashtra 420003
India
Nashik
MAHARASHTRA
422003
India |
| Phone |
8652013989 |
| Fax |
|
| Email |
gvikasg197@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shalyatanta department,OPD no. 1,Shree Saptashrungi Ayurved Mahavidyalaya And Hospital , KamalNagar , Hirawadi , Panchwati,
Nashik Maharashtra 422003 |
|
|
Primary Sponsor
|
| Name |
Department of Shalyatantra Shree Saptashrungi Ayurved Mahavidyalaya And Hospital |
| Address |
Department of Shalyatantra Samanya, Shree Saptashrungi Ayurved
Mahavidyalaya And hospital ,Kamal nagar Hiravadi, Panchavati, Nashik,
Maharashtra 422003 India |
| 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 Vikas Gupta |
Shree Saptashrungi Ayurved Mahavidyalaya And Hospital |
Department Of Shalyatanta,OPD no. 1,Shree Saptashrungi
Ayurved Mahavidyalaya
And Hospital,
Kamal Nagar , Hirawadi
, Panchawati , Nashik
422003
Nashik
MAHARASHTRA
Nashik
MAHARASHTRA |
8652013989
gvikasg197@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree Saptashrungi Ayurved Mahavidyalaya And Hospital Nashik Panchavati Nashik Maharashtra 422003 |
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 | Intervention Arm | Procedure | - | Lumbar Traction With Agnikarma Pradhan Karma | (Procedure Reference: Lumbar Traction - Journal Of Orthopaedic & Sports Physical Therapy , Agnikarma -Charaka Samhita And Shushruta Shamhita , Procedure details: Lumbar Traction Continuos Skin Type Traction Of 10% Of Body Weight For 45 Minutes For 7 days,once a day,Agnikarma At Kati And 4 Angul Above Gulf Pradesha on 1st And 7th day,Once A day)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Lumbar Traction | Procedure Reference: Lumbar Traction - Journal Of Orthopaedic & Sports Physical.
Lumbar Traction Continuos Skin Type Traction Of 10% Of Body Weight For 45 Minutes For 7 days,once a day |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
A Patient With The Following Symptoms Of Grudhrasi -
Ruka
Toda
Stambha
Spandana
Saktikshepanigrah
Patient With Positive S.L.R. Test
|
|
| ExclusionCriteria |
| Details |
-Patient Under Age Of 25yr And Over Age Of 60yr .
-Patient With Evidence Of Carcinogenicity
-Recent History Of Trauma, Fracture, Impact To Lower Extremity And Spine.
-people with spinal cord infection ,tuberculosis,bone cancer.
-Diabetes,stoke,convulsion, uncontrolled HTN, Ischemic heart disease
-Pregnancy
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce The Sign And Symptoms Of Grudhrasi |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To provide relief & reduce recurrence of disability. |
14 days |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
Final Enrollment numbers achieved (Total)= "76"
Final Enrollment numbers achieved (India)="76" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/12/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
22/12/2024 |
| Date of Study Completion (Global) |
08/10/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
OBJECTIVES: 1)Primary objective- • To Compare the efficacy Of Lumbar Traction With Agnikarma And Lumbar Traction Alone In Management Of Grudhrasi. 2) secondary Objective- •To study the Agnikarma in detail as per ayurvedic concept. •To study the lumbar traction in detail as per modern concept. • To study the effect of lumbar traction and Agnikarma in Grudhrasi.
PARTICIPANT 38 number of patients of each group having age between 25yr to 60yr suffering with sign and symptoms of Grudhrasi and meeting inclusion and exclusion criteria will be randomised And selected for study from OPD AND IPD department of shalyatantra of Shree Saptashrungi Medical College and Hospital Nashik.
INTERVENTIONS- 38 Patient In group A selected for lumbar traction and Agnikarma 38 Patient in group B selected for Lumbar Traction
Primary Outcome : Reduce the sign and symptoms of Grudhrasi.
Secondary outcome: Provide long term relief and reduce recurrence of disability.
Treatment Duration : 7 Days Follow Up :1th , 7th , 14th Days
Data Analysis :The Wilcoxon Signed Rank Test and Mann-Whitney U Test were used to analyze intra-group and inter-group differences. Both treatments showed significant symptom relief, with Agnikarma with Lumbar traction performing better in terms of overall percentage relief. Data will be analysed using appropriate statistical methods to compare the effectiveness of the both intervension group.
Ethical Considerations : The study will be conducted in accordence with ethical guidelines and with informed consent from participents.
|