| CTRI Number |
CTRI/2021/03/031737 [Registered on: 05/03/2021] Trial Registered Prospectively |
| Last Modified On: |
02/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Sciatica And Its Management Through Ayurveda |
|
Scientific Title of Study
|
A CLINICAL STUDY OF RAKTMOKSHANA AND VAJIGANDHADI TAILA MATRA BASTI IN GRIDHARSI W.S.R.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 SURABHI NEMIWAL |
| Designation |
MD Scholar |
| Affiliation |
DSRRAU,JODHPUR |
| Address |
P.G.Department of Panchakarma,University College of Ayurveda,University,Karwar,Nagaur Road,Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9610753503 |
| Fax |
|
| Email |
drsurbhinemiwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gyan Prakash Sharma |
| Designation |
Assistant Professor |
| Affiliation |
DSRRAU,JODHPUR |
| Address |
P.G.Department of Panchakarma,University College of Ayurveda,University,Karwar,Nagaur Road,Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9829798701 |
| Fax |
|
| Email |
atreyagyan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SURABHI NEMIWAL |
| Designation |
MD Scholar |
| Affiliation |
DSRRAU,JODHPUR |
| Address |
P.G.Department of Panchakarma,University College of Ayurveda,University,Karwar,Nagaur Road,Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9610753503 |
| Fax |
|
| Email |
drsurbhinemiwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Sarvepalli Radhakrishanan Rajasthan Ayurveda University,Jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr Sarvepalli Radhakrishanan Rajasthan Ayurveda UniversityJodhpur |
| Address |
Dr. Sarvepalli Radhakrishanan Rajasthan Ayurveda University,Karwar,Nagaur Road,Jodhpur,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 Gyan Prakash Sharma |
Dr.Sarvepalli Radhakrishanan Rajasthan Ayurveda University |
OPD No-6,P.G. Department Of Panchakarma,Dr. Sarvepalli Radhakrishanan Rajasthan Ayurveda University,Karwar,Nagaur Road,Jodhpur,
PIN-342307
Jodhpur
RAJASTHAN |
9829798701
atreyagyan@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:M543||Sciatica. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Vajigandhadi Matra Basti and Siravedhan |
GROUP A-Vajigandhadi Matra Basti for 15 days.
GROUP B-SIRAVEDHAN about 50 to 150 ml of blood is letted. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with uncomplicated sciatica.
2. Sciatica due to L4-L5-S1 lumber disc degenerative disease. |
|
| ExclusionCriteria |
| Details |
1.Patients with severe renal and cariac disease,Malignancy,Infectious condition of spine,severe anaemic,specific fever like dengue.
2.pregnant woman.
3.Patient who have lost the control on bowel and bladder.
4.Trauma.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in subjective and objective parameters |
15days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the comparative efficacy of the treatment in both the groups |
15 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 1 |
|
Date of First Enrollment (India)
|
12/03/2021 |
| 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
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sciatica is very painfull condition in which pain begins in lumber region and radiates along the postreolateral aspect of thigh and leg.In Ayurveda Siravedhan and Basti Karma which will be free from adverse affects and prevents recurance of the disease.This study is open labelled parallel group trial to prove the efficacy of Vajigandhadi Matra Basti and Rakhtmokashan in the management of Gridharsi w.s.r. sciatica. In one group,15 Patients will be administrered Vajigandhadi Matra Basti.In another group ,15 Patients will be administered with Siravedhan about 50 to 150 ml of blood is letted. |