| CTRI Number |
CTRI/2021/04/033221 [Registered on: 28/04/2021] Trial Registered Prospectively |
| Last Modified On: |
28/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Management of Sciatica through Ayurveda |
|
Scientific Title of Study
|
A comparative Clinical Study on Efficacy of Viddha Karma and Kati Pichu with Kubjaprasarani Taila in Management of Gridhrasi with special reference to Sciatica |
| Trial Acronym |
- |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC/ACA/2020/3-53 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
U M G D DE SILVA |
| Designation |
PG Scholor |
| Affiliation |
National Institute of Ayurveda. |
| Address |
Post Graduate Department of Panchakarma National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur
No 142 Govind Nagar West Amer road Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9119215448 |
| Fax |
911412635816 |
| Email |
gihani_silva@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Surendra Vedpathak |
| Designation |
Professor and Head of the Department |
| Affiliation |
National Institute of Ayurveda |
| Address |
Post Graduate Department of Panchakarma National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur
Post Graduate Department of Panchakarma National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7030309088 |
| Fax |
|
| Email |
drsurendravedpathak50@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Surendra Vedpathak |
| Designation |
Professor and Head of the Department |
| Affiliation |
National Institute of Ayurveda |
| Address |
Post Graduate Department of Panchakarma National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur
Post Graduate Department of Panchakarma National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7030309088 |
| Fax |
|
| Email |
drsurendravedpathak50@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute Of Ayrveda |
| Address |
Jorawar singh Gate Amer Road Jaipur |
| Type of Sponsor |
Other [ Ayurveda University] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Professor S M Vedpathak |
Head of the Department, Post Graduate Department of Panchakarma, National Institute of Ayurveda, Jorawar Singh gate, Amer Road, Jaipur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr U M G D De Silva |
National Institute of Ayurveda |
Jorawar singh Gate Amer Road Jaipur
Jaipur
RAJASTHAN |
9119215448
gihani_silva@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: Gridhrasi, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Kubjaprasarani Taila Kati Pichu |
External application of Kubjaprasarani Taila 250ml Once a daily for 14 days |
| Intervention |
Viddha Karma
|
Viddha Karma apply Day 1 Day 7 Day 14 |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients in the age group of 20 to 65 years of either sex.
2 Patients having sign and symptoms of Stambha(Stiffness), Ruk (Pain), Toda( Pricking sensation), Spandana(twitching) , starting from Sphikpurva –Kati-Janu-Jangha to Pada.( Radiatng pain,starting from the gluteal region towards the foot), (Heaviness) and Arochaka (anorexia)
3 Tenderness of the sciatic nerve course
4 Severe pain on squatting
5 Sensory change
6 Non-involvement of urinary bladder and rectum
7 Positive straight leg raising test |
|
| ExclusionCriteria |
| Details |
1 Age below 20 years and above 65 years
2 Chronicity more than ten years
3 Monoplegia, Paraplegia.
4 AVN of Hip joint, T.B. Hip/ Spine.
5 Pelvic pathology.
6 Traumatic lesion in Lumbo-sacral region.
7 Low Hb levels, Blood clotting disorders.
8 Patient receiving any kind of anticoagulants/ blood thinners |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce the Stambha(Stiffness), Ruk (Pain), Toda(Pricking sensation), Spandana(twitching) , starting from Sphikpurva –Kati-Janu-Jangha to Pada.( Radiatng pain,starting from the gluteal region towards the foot), (Heaviness) and Arochaka (anorexia) |
Reduce the Stambha(Stiffness), Ruk (Pain), Toda(Pricking sensation), Spandana(twitching) , starting from Sphikpurva –Kati-Janu-Jangha to Pada.( Radiatng pain,starting from the gluteal region towards the foot), (Heaviness) and Arochaka (anorexia) in 14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement of the straight leg raising and Oswestry Disability Index (ODI) |
14 days |
| 100 meters walking distance |
14 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
30/06/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, open label, parallel group, single centre comparative clinical study. This study will be conducted in the National Institute of Ayurveda, Jaipur, Rajasthan, India. The null hypothesis is there is no difference between the efficacy of Viddha Karma and Katipichu with Kubjaprasarani Taila in the management of Gridhrasi with special reference to Sciatica. The primary outcome measures reduction in Ruka (Pain), Toda (Pricking pain), Stamba ( Stiffness), Spandana (Twitching), Gaurawa (Heaviness) and Arochaka (Anoroxia). Secondary outcome is improvement of 100 meters test, straight leg raising test and Oswestry Disability Index (ODI). The Viddha Karma will be done on day 1, day 7 and day 14 and Kubjaprasarani Taila pichu will be done on 250ml once a daily for 14 days. |