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CTRI Number  CTRI/2024/10/074671 [Registered on: 03/10/2024] Trial Registered Prospectively
Last Modified On: 01/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Patients who suffer from low back pain (also known as lumber spondylosis) were the subjects of a clinical investigation that investigated the effects of kativasti and yogic practices. 
Scientific Title of Study   A clinical Study of Kativasti and yogic Practices in Katishoola (Lumber spondylosis) 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KHAGENDRA KUSHWAH 
Designation  RESEARCH SCHOLAR 
Affiliation  Faculty of Ayurveda, IMS BHU 
Address  Dhanwantari bhavan, Department OF Panchkarma, Faculty of Ayurveda, IMS BHU

Varanasi
UTTAR PRADESH
221005
India 
Phone  8534005810  
Fax    
Email  Khagendrakushwaha@bhu.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Prof Jai Prakash Singh 
Designation  Professor 
Affiliation  Banaras Hindu University 
Address  Faculty of Ayurveda, Institute of Medical Science, Banaras Hindu University
Dhanwantri Bhawan,Deparment of Panchakarma, faculty of Ayurveda, Institute of Medical of Science, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India 
Phone  9415814351  
Fax    
Email  jp.singh1@bhu.ac.in  
 
Details of Contact Person
Public Query  
Name  Prof Jai Prakash Singh 
Designation  Professor 
Affiliation  Banaras Hindu University 
Address  Faculty of Ayurveda, Institute of Medical Science, Banaras Hindu University
Dhanwantri Bhawan,Deparment of Panchakarma, faculty of Ayurveda, Institute of Medical of Science, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India 
Phone  9415814351  
Fax    
Email  jp.singh1@bhu.ac.in  
 
Source of Monetary or Material Support  
OPD No. 16 C, Department of Panchakarma,Ayurveda Faculty, Sir Sundar Lal Hospital, IMS Banaras Hindu University.  
 
Primary Sponsor  
Name  Banaras Hindu university 
Address  Faculty of Ayurveda, Institute of Banaras Hindu university Varanasi Uttarpradesh  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jai Prakash Singh  Sir Sundarlal Hospital   OPD NO.16C Department of Panchkarma Ayurveda Faculty Banaras Hindu University
Varanasi
UTTAR PRADESH 		 9415814351

jp.singh1@bhu.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M470||Anterior spinal and vertebral artery compression syndromes. Ayurveda Condition: SANDHIGATAVATAH, (2) ICD-10 Condition: M478||Other spondylosis, (3) ICD-10 Condition: M472||Other spondylosis with radiculopathy,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Yoga Intervention30 minutes yoga package. i.e. shukshmavyayayma, aasana , panayama.
2Intervention ArmProcedure-kaTibastiH, कटिबस्तिः (Procedure Reference: Charak Samhita, Procedure details: In the Kativasti group, 60 persons suffering from Lumbar spondylosis will be given Kativasti for 45 minutes using sesame oil at a temperature of 42 to 48 degrees Celsius for 7 days every month for 3 months & will be followed up every month.)
(1) Medicine Name: Sesame oil, Reference: Charak Samhita, Route: Topical, Dosage Form: Taila, Dose: 150(ml), Frequency: od, Duration: 7 Days
Intervention  Kativasti   60 patients are in this group. and we take patients give Kativasti in a week on per month.  
Comparator Agent  yoga Techniques  60 patients in this group. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Male and female in the age group of 20 to 60 suffering from Lumbar Spondylosis will be included.
2. Persons suffering from pain arising from lumbar vertebrae will be included.
3. Based on Kellgren-Lawrence (KL) criteria, victims from KL 1 to KL 3 will be included. 
 
ExclusionCriteria 
Details  1. Women and men in the age group below and above 20 to 60. who are suffering from Lumbar Spondylosis will not be included.
2 Casualties related to the gluteal muscles will not be included.
3. Waist fracture victims will not be included.
4. Those with accidental cases will not be included.
5. Patients suffering from saffron will not be included.
6. Pregnant women will not be included.
7. People suffering from leprosy or epilepsy will not be included.
8. Those who are unable to speak or are mentally retarded will not be included.
9. Patients with KL 0 and KL 4 based on Kellgren-Larins (KL) criteria will not be included.
10. People suffering from other diseases along with Lumbar Spondylosis will not be included. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Effect of selected yoga exercises in Lumbar Spondylosis. with WOMAC LK3.1 to show a result as Lumbar Spondylosis will be cure.

2. Effect of lumbar spondylosis with sesame oil has also will be cure. 		 Effect of selected yoga exercises in Lumbar Spondylosis. each group provide 90 day packages.
2. Effect of lumbar spondylosis with sesame oil.
The WOMAC pain scale consists of five items: (1) walk- ing on flat ground; (2) going up or down stairs; (3) at night while in bed; (4) sitting or lying; and (5) standing upright. Total WOMAC pain scale scores can vary from 0 to 500 when VA3 scaling is applied and from 0 to 20 when LK3 scaling is implemented. 
 
Secondary Outcome  
Outcome  TimePoints 
Re-calculation of previous data on large Scale.  90days 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 3 
Date of First Enrollment (India)   14/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  14/10/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
If yoga exercises are done for the patients suffering from low back pain then this exercise removes the stiffness of their back bones and brings less flexibility in the back region which will give them relief from this disease.If the Kati Basti Panchkarma procedure is done for the patients suffering from low back pain, then its effect falls on the Kashmir village of the Kati region of the patients because the stiffness in the muscles is removed by this Kati Basti procedure and the Kashmir village becomes stronger due to this.
JRF, Research Scholar: And the bones in Kashmir village of Kati region which become weak due to the weathering process will become stronger, hence it will be beneficial
 
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