Role of Vedanasthapana Mahakashay (Decoction), Kati Basti &Yoga Modalities in the Management of Acute Lumbosacral sprain/strain /kati shool

Phase 2

Completed

• Conditions: Patients with typical clinical features pertaining to Acute Lumbosacral sprain/strain

• Registration Number: CTRI/2018/02/012161
• Lead Sponsor: National Institute of Ayurveda

Brief Summary

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 group**Cold therapy for a short period (up to 48 h) and *VedanaSthapana Mahakashay* (Decoction) 30 ml twice daily for next 1 week (acute/recovery phase)and*Kati 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 Group**Cold 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 propertiesof *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 applicationseemed 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-15
• Study Completion: 2019-01-19
• Last Update Posted: 2022-02-21

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Patients with typical clinical features pertaining to Acute Lumbosacral sprain/strain 2.Patients willing to undergo trial.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients with typical clinical features pertaining to Acute Lumbosacral sprain/strain	Patients with typical clinical features pertaining to Acute Lumbosacral sprain/strain | Age 20-60 year.
Age 20-60 year.	Patients with typical clinical features pertaining to Acute Lumbosacral sprain/strain | Age 20-60 year.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Institute of Ayurveda,jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

National Institute of Ayurveda,jaipur

🇮🇳Jaipur, RAJASTHAN, India

Dr Ashok Kumar

Principal investigator

9649180572

ashok_hp1976@yahoo.com