| CTRI Number |
CTRI/2020/02/023433 [Registered on: 19/02/2020] Trial Registered Prospectively |
| Last Modified On: |
17/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of Sciatica disease by the principles of Ayurveda |
|
Scientific Title of Study
|
A comparative clinical evaluation of Siravedha and Agnikarma in the management of Gridhrasi(Sciatica) |
| Trial Acronym |
SMBA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pragna Baria |
| Designation |
Research scholar |
| Affiliation |
IPGT and RA GAU Jamnagar |
| Address |
Department of shalya Tantra IPGT and RA Gujarat Ayurveda University Jamnagar
Gujarat 361008
India
Opposite B devision police station GAU Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9686351392 |
| Fax |
|
| Email |
drpragnabaria15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anup B Thakar |
| Designation |
Professor/ Director |
| Affiliation |
IPGT and RA GAU Jamnagar |
| Address |
Director office IPGT and RA India 361008
5th floor academic building IPGT and RA GAU Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anup B Thakar |
| Designation |
Professor/ Director |
| Affiliation |
IPGT and RA GAU Jamnagar |
| Address |
Director office IPGT and RA India 361008
5th floor academic building IPGT and RA GAU Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute for Post graduate teaching and research in Ayurveda Jamnagar Gujarat 361008 |
|
|
Primary Sponsor
|
| Name |
Institute for post graduate teaching and research in Ayurveda |
| Address |
Gujarat ayurveda University Jamnagar Gujarat 361008 |
| 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 |
| Pragna Baria |
PG Hospital IPGT and RA |
OPD no 1 Shalya tantra department
Jamnagar
GUJARAT |
9686351392
drpragnabaria15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M543||Sciatica, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A Agnikarma procedure |
Minimum 15 Patients with clinical diagnosis of Gridhrasi will be treated with Agnikarma procedure |
| Comparator Agent |
Group B Siravedha procedure |
Minimum 15 patients with clinical diagnosis of Gridhrasi will be treated with siravedha procedure |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of Sciatica
Patients of Sciatica having SLR 30-70 degree
Positive Lasegue sign |
|
| ExclusionCriteria |
| Details |
Age less then 30 and more than 70 years
Uncontrolled diabetes mellitus and Hypertension
Uncontrolled TB of spine & hip joint
Malignancy
Avascular necrosis
Pregnancy
Anaemia
Heart disease
Fracture related to spine
Pitta dominant prakriti patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in signs and symptoms of Gridhrasi |
1 month from the day of the enrollment of patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improves quality of life of person |
After 2 months from the day of enrollment of patient
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
22/02/2020 |
| Date of Study Completion (India) |
25/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This research
started with the
aim and objective
to find the individual and comparative effect of both therapies i.e.
Agnikarma and Siravedha. In this study total 30 patients registered were
non-randomly divided in two groups.
15 patients in group A and 15 patients in Group B were registered. All 15
patients in group A and 15 Patients in Group B completed the treatment and follow up. In Group A, Agnikarma was done with Panchdhatu
Shalaka at Antrakandra Gulpha Sthana (Lumbo Sacral Spine as well as Ankle region). Total four sitting of procedure Agnikarma were done with a gap of 7 days interval. In Group B, Siravedha was done at 4 Angulas above or below Janu Sandhi
by scalpel vein set. Total
two sitting
of procedure
Siravedha were done with a gap of 15 days interval. Patients were observed
for relief in
sign and symptoms like radiating pain, Stambha, Suptata, Spandana, Gaurava etc.
at weekly interval
up to 4 weeks. The follow up was done up to one month after treatment in both groups.
Finally study concluded that both
para-surgical modalities have definite role in treating sciatica but Agnikarma
has shown better
result in
comparison of Siravedha in the management of Gridhrasi (Sciatica).
|