Comparative clinical trial on the effect of bandage with saksheerasidha balataila against murivenna in acute ligament injuries of ankle joint- Grade I and II
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Tenderness : Reduction in tenderness assessed by grading.
Study Overview
Brief Summary
The trial will be conducted to assess the effect of Saksheerasidha balataila, mentioned in Yogamrutham for bandaging in Acute ligament injuries of ankle joint Grade I and II and compare it with Murivenna bandage .The study will be conducted in participants who are clinically diagnosed with acute ligament injuries of ankle joint Grade I and II attending the OP and IP, Department of Salyatantra ,Government Ayurveda College Tripunithura, in the age group 18 to 50 years, who satisfy the inclusion and exclusion critera. The study duration is 14 days. Primary outcomes are pain , tenderness ,swelling and ankle function. Pain and tenderness is assessed by grading, swelling is assessed by measuring the size of ankle joint and ankle function is assessed by increase in the range of movements using goniometer in degree. Assessment will be done on 0th day, 7th day and 14th day.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Both male and female participants in the age group of 18 years to 50 years will be enrolled.
- •Participants who are diagnosed with acute ligament injuries of ankle joint-Grade I and II by clinical examination
- •Participants with written informed consent.
Exclusion Criteria
- •Participants with less than 18 years and above 50 years of age will be excluded.
- •Participants with fractures, dislocation and open wounds in and around ankle and foot.
- •Associated with Achilles tendon rupture.
- •Known case of tuberculosis of ankle joint and uncontrolled diabetes.
Outcomes
Primary Outcomes
Tenderness : Reduction in tenderness assessed by grading.
Time Frame: Each subject will be managed with a treatment period for 14 days. | Assessement will be done on 0th,7th,14th days.
Pain : Reduction in pain assessed by grading.
Time Frame: Each subject will be managed with a treatment period for 14 days. | Assessement will be done on 0th,7th,14th days.
Swelling : Reduction in swelling by measuring size of ankle joint.
Time Frame: Each subject will be managed with a treatment period for 14 days. | Assessement will be done on 0th,7th,14th days.
Ankle function: Increase the range of movement by assessing in goninometer in degree.
Time Frame: Each subject will be managed with a treatment period for 14 days. | Assessement will be done on 0th,7th,14th days.
Secondary Outcomes
- No secondary outcome(Not applicable)