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
|
|
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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