| CTRI Number |
CTRI/2020/03/024268 [Registered on: 26/03/2020] Trial Registered Prospectively |
| Last Modified On: |
30/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Panchakarma procedures in the management of Lumber Spondylosis |
|
Scientific Title of Study
|
Comparative Efficacy Study of Baladiyapana Basti and Bala Taila Matra Basti in the Management of Katigraha w.s.r. to Lumbar Spondylosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kshipra Rajoria |
| Designation |
Lecturer at P.G. Department of Panchakarma National Institute of Ayurveda Jaipur |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Room no.6 Department of Panchakarma National Institute of Ayurveda Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9001454100 |
| Fax |
|
| Email |
kshiprarajoria@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kshipra Rajoria |
| Designation |
Lecturer at P.G. Department of Panchakarma National Institute of Ayurveda Jaipur |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Room no.6 Department of Panchakarma National Institute of Ayurveda Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9001454100 |
| Fax |
|
| Email |
kshiprarajoria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sachin Sharma |
| Designation |
M.D. Scholar |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Room no.6 Department of Panchakarma, National Institute of Ayurveda Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9805442774 |
| Fax |
|
| Email |
sachinsharma1745@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jorawar Singh Gate Amber Road Jaipur Rajasthan 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jorawar Singh Gate Amber Road Jaipur |
| Address |
National Institute of Ayurveda Jorawar Singh Gate Amber Road Jaipur 302002 Rajasthan |
| 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 |
| Sachin Sharma |
National Institute of Ayurveda Jaipur |
OPD and IPD of Department of Panchakarma National Institute of Ayurveda Jorawar Singh Gate Amber Road Jaipur 302002
Jaipur
RAJASTHAN |
9805442774
sachinsharma1745@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: M478||Other spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Baladiyapana Basti |
Baladiyapana Basti will be administered in a dose of 600 ml every day through Rectal route as per the Standard Operating Procedure (SOP) of Nirhu Basti administration of the P.G. Department of the Panchakarma for a treatment period of 16 day. The time of administration will be early Noon (empty stomach) . |
| Intervention |
Bala Taila Matra Basti |
Bala Taila Matra Basti will be administered in a dose of 60 ml every day through Rectal route as per the Standard Operating Procedure (SOP) of Anuvasna Basti of the P.G. Department of the Panchakarma for a treatment period of 16 days.The time of administration will be Late Noon(immediately after meal) |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from classical signs and symptoms of Katigraha w.s.r to Lumbar spondylosis.
2. Patients between 40 yrs to 60 yrs of age.
3. Male or female Patient willing and able to participate in the study for 16 days and follow up period of 15 days.
4. Patients able to provide informed consent.
5.Grade 2 and Grade 3 in X-ray findings through Lane Radiographic grading of lumbar disc degeneration on lateral views. |
|
| ExclusionCriteria |
| Details |
1.Patients suffering from any acute diseases, infectious diseases, metabolic diseases, chronic diseases (like rheumatoid Arthritis, DM, Gout, TB, SLE, Ankylosing spondylitis etc) and other disease that may interfere with the course of treatment.
2. Patients suffering from Stenosis of spinal canal, Myelopathy (MRI optional), Lumbar carcinoma, spinal tumour or malignant tumours in any part of the body.
3. All type of Lumbar surgery or implanted instrumentation or prosthesis.
4. Patient having chronicity more than 5 yrs.
5. Pregnant women and lactating women are excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The assessment of the clinical response by VAS (Visual Analogue Scale) and Oswestry disability index (ODI) scales |
One Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The assessment of the clinical response by Physical component scores (PCS) of SF-36 |
One Month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2020 |
| Date of Study Completion (India) |
08/06/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This trial will be done to compare clinical efficacy of Baladiyapana Basti and Bala Taila Matra Basti in the management of Katigraha with special reference to Lumbar Spondylosis. This is an interventional, randomized,open clinical trial. The sample size is 60 with 2 groups, each group having a sample size of 30 patients. In group A Baladiyapana Basti will be administered in a dose of 600 ml every day through Rectal route as per the Standard Operating Procedure (SOP) of Nirhu Basti administration of the P.G. Department of the Panchakarma for a treatment period of 16 day. The time of administration will be early Noon (empty stomach) .In group B Bala Taila Matra Basti will be administered in a dose of 60 ml every day through Rectal route as per the Standard Operating Procedure (SOP) of Anuvasna Basti of the P.G. Department of the Panchakarma for a treatment period of 16 days. The time of administration will be Late Noon (immediately after meal ~ Aadhrapani ).The assessment of the clinical response in the total number of patients will be made on - Primary outcome – VAS (Visual Analogue Scale) and Oswestry disability index (ODI) scale and Secondary outcome – Physical component scores (PCS) of SF-36.Primary assessment of the patients will be done at baseline. Regular assessment will be done on every visit till completion of trial i.e. on 16th day. Patient will be further followed up on fifteenth day after the completion of the trial. |