Randomised Comparative Clinical Evaluation Of A Developed Nagaradi Choorna Patch And Herbal Patch In Pain Management Of Ankle Sprain
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- PARUL INSTITUTE OF AYURVED
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Pain Reduction, Swelling, and Range of Motion Assessed Using the Karlsson Peterson Scoring
Overview
Brief Summary
Ankle sprain is a common injury affecting 75% of the working population, with 1-2% of people requiring medical care daily. It occurs due to sports activities, accidents, sudden twisting, or walking on uneven ground, leading to pain, swelling, and restricted movement.
Despite various treatments like painkillers, anti-inflammatory drugs, and immobilization, there is no clear consensus on the best approach, often resulting in longer recovery times and higher medical costs.
This study explores Nagaradi Lepa, a herbal paste applied directly to the injured area, as a natural, targeted treatment to reduce dependency on oral medications and promote faster, safer recovery.
Hence the need and uniqueness of study
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Diagnose cases of first and second grade ankle sprain, radiologically absence of fracture or dislocation.
- •2.Both of the gender in the age group 18 to 50 years 3.Recent onset, less than two weeks.
- •Unilateral Ankle sprain.
Exclusion Criteria
- •1.Patients associated with third grade and radiologically fracture or dislocation.
- •2.Patients below 18years and above 50years of age.
- •3.Chronicity more than two weeks.
- •Bilateral Ankle sprain
- •Wound site
- •HIV:+ve, HBsAg:+ve, VDRL:+ve,.
Outcomes
Primary Outcomes
Pain Reduction, Swelling, and Range of Motion Assessed Using the Karlsson Peterson Scoring
Time Frame: From Commencement of Pain, Swelling, and Range of Motion on Day 1, Day 8, and Day 21
Secondary Outcomes
- The duration needed for the patient to achieve full functional recovery & return to daily activities AND Recorded to determine whether patients required supplementary pain relief(From Commencement of Pain, Swelling, & Range of Motion on Day 1, Day 8, & Day 21)
Investigators
Dr Sweta Mer
PARUL INSTITUTE OF AYURVED