| CTRI Number |
CTRI/2017/09/009942 [Registered on: 28/09/2017] Trial Registered Prospectively |
| Last Modified On: |
21/09/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Study on Vatari Guggulu Internally and Pippalyadi Taila Enema Therapy in Management of Sciatica |
|
Scientific Title of Study
|
Clinical Evaluation of Combined Effectiveness of Vatari Guggulu and Pippalyadi Taila Matra Basti in Management of Gridhrasi (Sciatica) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sruthy Nair |
| Designation |
Post Graduate Scholar Dept Of Kayachikitsa |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
BM Road Thanniruhalla Hassan 573201 Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
08172256460 |
| Fax |
|
| Email |
sruthynairpadma94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Diwakar Papurao Joshi |
| Designation |
Associate Professor and Head, Dept Of Kayachikitsa |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
BM Road Thanniruhalla Hassan 573201 Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
08172256460 |
| Fax |
|
| Email |
joshidpayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Diwakar Papurao Joshi |
| Designation |
Associate Professor and Head, Dept Of Kayachikitsa |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
BM Road Thanniruhalla Hassan 573201 Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
08172256460 |
| Fax |
|
| Email |
joshidpayu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka India
08172256460
sdmcah@gmail.com |
|
|
Primary Sponsor
|
| Name |
ri Dharmasthala Manjunatheshwara College of Ayurveda and HospitalHassan |
| Address |
Post Graduate Scholar Dept Of Kayachikitsa Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka 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 Sruthy Nair |
Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital Hassan |
OPD 4, Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital Hassan BM Road Thanniruhalla Hassan 573201 Karnataka India
Hassan
KARNATAKA |
08172256460
sruthynairpadma94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road, Thanniruhalla Hassan 573201 Karnataka India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Gridhrasi (Sciatica), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NONE |
NONE |
| Intervention |
Vatari Guggulu (orally) and Pippalyadi Taila (through enema)
|
Vatari Guggului will be given 2 tablet (500 mg) thrice daily with lukewarm water after food for 16 days.
Pippalyadi Taila Basthi
Pippalyadi Taila will be given 70 ml once a day for 8 days through anal route |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
(a) DIAGNOSTIC CRITERIA
Patients with features of Gridhrasi (sciatica) like
1. Ruk on SphikPoorva, Kati, Prishta, Uru, Janu, Jangha and Pada Paryanta (Pain radiates from low back to the leg/s)
2. Toda (Pricking sensation)
3. Stambha (Stiffness)
4. Spandana (Fasciculation)
5. Positive Straight Leg Raising test
6. Positive Breggard’s sign
7. Laseague’s sign
8. Bowstring sign
9. Tenderness of nerves
10. Sensory changes
INCLUSION CRITERIA:
1. Unilateral leg pain extending below the knee (with or without strength,sensory or reflex changes) and a positive straight leg raising sign
2. Those who are fit for Basti treatment
3. Patients of intervertebral disc prolapsed,lumbar spondylosis,lumbo sacral strain
4. Those patients who are ready to sign informed consent form |
|
| ExclusionCriteria |
| Details |
1. Neoplastic and infective conditions of the spine
2. Uncontrolled Diabetes mellitus, Uncontrolled Hypertension, Neurological complications
4. Fractures of pelvis and femur
5. Pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective parameters:
Ruk (pain)
Stambha (stiffness)
Toda (pricking sensation)
Gauravata(Heaviness)
Gait
Objective Parameters:
Straight leg raising test
Visual analog scale for pain
Flip test
Laseague’s sign
Breggard’s sign
X-ray
|
16 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Toda (pricking sensation)
Gauravata(Heaviness) |
16 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
|
N/A |
|
Date of First Enrollment (India)
|
02/10/2017 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Current clinical study is clinical evaluation of combined
effectectiveness of vatari guggulu and pippalyadi taila matra basti
in the management of gridrasi (Sciatica).In the present study, an
open label single arm clinical trial at IPD basis will be done with
pre and post-test design for the included 30 patients.Here vatari
guggulu 500 mg thrice daily in the morning and night will be
administered after food with ushnodaka as anupana for the first 8
days.Along with this pippalyadi thaila anuvasana basti 70 ml will be
giving once in a day for 8 days The patient will be discharged with
vatari guggulu for the next 16 days..Hence the entire treatment will
be completed in 16 days.
The patient will
be assessed on the 1st day 8th day and 16th
day. Assessment would be done based on subjective and objective
parameters and would also be monitored for Adverse Drug Reactions or
Adverse Drug Effects or other concurrent illness.
|