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CTRI Number  CTRI/2018/02/012161 [Registered on: 26/02/2018] Trial Registered Prospectively
Last Modified On: 21/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of Vedanasthapana Mahakashay (Decoction), Kati Basti &Yoga Modalities in the Management of Acute Lumbosacral sprain/strain /kati shool 
Scientific Title of Study   Role of Vedanasthapana Mahakashay (Decoction), Kati Basti &Yoga Modalities in the Management of Acute Lumbosacral sprain/strain 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashok Kumar 
Designation  Assistant Professor  
Affiliation  National Institute of Ayurveda Jaipur rajasthan 
Address  P.G. DEPARTMET OF SHALYA TANTRA National Institute of Ayurveda, Jaipur Rajasthan 302002
National Institute of Ayurveda,madho vilash Jaipur Rajasthan 302002
Jaipur
RAJASTHAN
302002
India 
Phone  9649180572  
Fax    
Email  ashok_hp1976@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Narinder Singh  
Designation  Assistant Professor 
Affiliation  National Institute of Ayurveda Jaipur rajasthan 
Address  P.G. DEPARTMET OF SHALYA TANTRA National Institute of Ayurveda, Jaipur Rajasthan 302002
National Institute of Ayurveda, Madho vilash Jorwar singh gate Jaipur Rajasthan 302002
Jaipur
RAJASTHAN
302002
India 
Phone  9549370912  
Fax    
Email  narinder.1973@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr LOKESH YADAV 
Designation  MS SCHOLAR 
Affiliation  National Institute of Ayurveda Jaipur rajasthan 
Address  P.G. DEPARTMET OF SHALYA TANTRA National Institute of Ayurveda, Jaipur Rajasthan 302002
vill kultajpur teh kishangrah bas post bas kripal nagar dist alwar rajasthan 301405
Alwar
RAJASTHAN
302002
India 
Phone  9461040988  
Fax    
Email  lokeshyadav92.ly@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Jaipur (Raj)-302002. 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  National Institute of Ayurveda, Jaipur (Raj)-302002.  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr Ashok Kumar  P.G. DEPARTMET OF SHALYA TANTRA National Institute of Ayurveda, Jaipur (Raj)-302002.  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashok Kumar  National Institute of Ayurveda,jaipur  National Institute of Ayurveda, joravar singh gate aamer road Jaipur (Raj)-302002
Jaipur
RAJASTHAN 
9649180572

ashok_hp1976@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients with typical clinical features pertaining to Acute Lumbosacral sprain/strain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1.VedanaSthapana Mahakashay (Decoction) 2.Dashmool taila   Cold therapy for a short period (up to 48 h) VedanaSthapana Mahakashay (Decoction) 30 ml twice daily for next 1 week (acute/recovery phase)Kati Basti 45 minutes for 5 days with Dashmool Taila Yoga modalities 15minutes daily for next for 7 days 
Comparator Agent  DiclofenacPottassium50mg therapeutic ultrasound   Cold therapy for a short period (up to 48 h) DiclofenacPottassium50mg twice daily for next 1 week (acute/recovery phase)therapeutic ultrasound of 5 minutes for 5 days proprioceptive neuromuscular facilitation (PNF)15 minutes daily for next for 7 daysproprioceptive neuromuscular facilitation (PNF)15 minutes daily for next for 7 days  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients with typical clinical features pertaining to Acute Lumbosacral sprain/strain
2.Patients willing to undergo trial 
 
ExclusionCriteria 
Details  i.Not willing to undergo trial.
ii.Patients reporting after initial 48 hours of Injury.
iii.Chronic Lumbosacral sprain/strain
iv.Suffering from specific variety of conditions like infective lesions,skeletal injuries fractures, spondylolisthesis/disc prolapsed with lumber canal stenosis or rediculopathies.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Patients with typical clinical features pertaining to Acute Lumbosacral sprain/strain
Age 20-60 year.
 
Patients with typical clinical features pertaining to Acute Lumbosacral sprain/strain
Age 20-60 year.
 
 
Secondary Outcome  
Outcome  TimePoints 
Study the efficacy of VedanaSthapana Mahakashay (Decoction), Kati Basti, (PNF)passive/active stretching& Yoga modalitiesin the management of Lumbosacral Sprain/strain on clinical parameters  Study the efficacy of VedanaSthapana Mahakashay (Decoction), Kati Basti, (PNF)passive/active stretching& Yoga modalities 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/06/2018 
Date of Study Completion (India) 19/01/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
TWO RESEARCH PAPERS PUBLICATION: 1. Role of vedanasthapana mahakashay (decoction), kati basti &yoga modalities in the management of acute lumbosacral sprain/strain. Wjpls/2386/5/2019 RESEARCH PAPERS UNDER PUBLICATION: 1.1. A Critical Review of Kati shoola w.s.r. to Acute Lumbosacral Sprain/Strain, journal of Ayurveda,N.I.A. Jaipur, D. No. NIA/JOA.  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Prospectiveunicentral randomized clinical study (Computer generated randomization will be followed)Total 30 patients will be selected on the basis of procedure and will be divided in two equal groups (15 patients in each group):Each group have three phase  1. Acute Phase(initial 48 hours) 2.Recovery Phase(5 days) 3.Maintenance Phase(7 days)

Trial groupCold therapy for a short period (up to 48 h) and VedanaSthapana Mahakashay (Decoction) 30 ml twice daily for next 1 week (acute/recovery phase)andKati Basti followed by soft-tissue sports massage daily for the duration of  45 minutes for  5 days with Dashmool Taila in the recovery phase and Yoga modalities  15minutes daily for next for 7 days. particularly focusing the abdominal, paraspinal, and hip muscles are advised.Control GroupCold therapy for a short period (up to 48 h)and DiclofenacPottassium50mg  twice daily for next 1 week (acute/recovery phase) and therapeutic ultrasound daily over affected region for the duration of 5 minutes for 5 days in the recovery phase and proprioceptive neuromuscular facilitation (PNF)15 minutes daily for next for 7 days.Suitable Grading will be designed for the assessment parameters. The observations will be analyzed on the basis of assessment parameters critically and clinically on day 1, completion of 1st week & 2nd week.

After completion of study:

Overall effect of interventions:

·         Overall relief of 85.17% was observed in Group B.

·         Overall relief of 80.77%, was observed in Group A.

·         Group B was found to be slightly more effective in comparison to group A. 

·         On inter group comparison the difference of the outcome on assessment parameters was found to be non-significant. so in other words it could be ascertained that both the protocols were found to be equally effective in terms of the outcome.

The better outcome in Group B could be attributed to the

 VedanaSthapana Mahakashay, having pharmaco-therapeutic properties of Vata Shamaka, Shoolahara, Vedana Sthapaka,  opposite to that of properties of vata so it may have acted as a potent vata pacifier in  normalizing  the vitiated vata.

Kati Basti with Dashmool taila as local application seemed to be acted as effective vata pacifier in managing the vitiated vata, musculature strengthening & flexibility.

 Yoga modalities probably increased blood circulation, leading to effective clearance of metabolites and enhanced delivery of nutrient to the affected tissues hence strengthening the muscles of the lower back relieving the lumbo-sacral sprain/ strain.

 

 

  

 

 
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