| CTRI Number |
CTRI/2021/05/033368 [Registered on: 04/05/2021] Trial Registered Prospectively |
| Last Modified On: |
23/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Management of Sciatica through Ayurveda |
|
Scientific Title of Study
|
Clinical Study to Evaluate the Efficacy of Dashmooladi Kashaya in the 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 Pawan kumar Jhiginiya |
| Designation |
MD Scholar |
| Affiliation |
DSRRAU Jodhpur |
| Address |
PG Department of Kaya Chikitsa DSSRAU Campus (Rajasthan)
PG Department of Kaya Chikitsa DSSRAU Campus (Rajasthan)
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7877225989 |
| Fax |
|
| Email |
pkjhinganiya92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Brahmanand Sharma |
| Designation |
Associate proffesor |
| Affiliation |
DSRRAU Jodhpur |
| Address |
PG Department of Kaya Chikitsa DSSRAU Campus (Rajasthan)
PG Department of Kaya Chikitsa DSSRAU Campus (Rajasthan)
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7976964483 |
| Fax |
|
| Email |
bkmudgal9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pawan kumar Jhiginiya |
| Designation |
MD Scholar |
| Affiliation |
DSRRAU Jodhpur |
| Address |
PG Department of Kaya Chikitsa DSSRAU Campus (Rajasthan)
PG Department of Kaya Chikitsa DSSRAU Campus (Rajasthan)
Jodhpur
RAJASTHAN
342037
India |
| Phone |
7877225989 |
| Fax |
|
| Email |
pkjhinganiya92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr sarvepalli Radhakrishnan Rajasthan Ayurveda University Nagaur Road Karwar Jodhpur Rajasthan |
|
|
Primary Sponsor
|
| Name |
Dr sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur |
| Address |
Dr sarvepalli Radhakrishnan Rajasthan Ayurveda University Nagaur Road Karwar jodhpur Rajasthan PIN-342037 |
| 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 Brahmanand Sharma |
Dr sarvepalli Radhakrishnan Rajasthan Ayurveda University,University hospital of Ayurveda |
OPD NO 4 PG Department of Kaya Chikitsa DSRRAU Campus Karwar Nagaur Road
Jodhpur
RAJASTHAN |
7976964483
bkmudgal9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The institutional Ethics Committee DSRRAU Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G544||Lumbosacral root disorders, not elsewhere classified. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dashmooladi Kashaya |
Dashmooladi Kashaya in the dose of 20ml mixed with 10-15 ml of Erand tail twice a days with luke warm water for 45 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Well diagnosed & confirmed patient of Sciatica on the basis of Modern texts.
2. Patients with presence of Ruk, Toda, Stambha and Spandana in the Sphik, Kati, Uru, Janu, Jangha and Pada
3. Patient with tenderness along the course of Sciatic nerve.
4. S.L.R. test in affected leg as objective measure for diagnosis as well as for improvement of the treatment.
5. Popliteal Compression Test.
6. Foot Flexion Test.
7. Knee-Jerks and Ankle-Jerks.
|
|
| ExclusionCriteria |
| Details |
The patients suffering from following conditions will be excluded from the study.
1.Cancer of spine
2.Tumour of Cauda Equina and Lumbosacral Plexus
3.Uncontrolled Diabetes Mellitus
4.Cardiovascular Disease
5.Pregnancy
6.Tuberculosis of Vertebral Column
|
|
|
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 |
| Improvement in subjective and Objective parameter. |
45 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the efficacy of ttreatmrnt |
45 days |
|
|
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 2 |
|
Date of First Enrollment (India)
|
30/05/2021 |
| 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 single group randomized trial to find out the efficacy of Dashmooladi Kashaya in the management of Gridhrasi. In single group 40 well diagnosed and registered patients of Gridhrasi(Sciatica) will be given Dashmooladi Kashaya in the dose of 20ml mixed with 10-15 ml of Erand tail twice a day with luke warm water for 45 days. |