A clinical trial to compare effect of two tailas used for bandaging,saksheerasidha balataila and murivenna in patients with acute ligament injuries of ankle joint- Grade I and II

Phase 3

Recruiting

• Conditions: Sprain of ankle. Ayurveda Condition: UTPISHTA-SANDHIMUKTAM,

• Registration Number: CTRI/2022/07/043783
• Lead Sponsor: Government Ayurveda College Tripunithura

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-07
• Last Update Posted: 2022-09-19

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 50

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 3.
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tenderness : Reduction in tenderness assessed by grading.	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.	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.	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.	Each subject will be managed with a treatment period for 14 days. | Assessement will be done on 0th,7th,14th days.

Secondary Outcome Measures

Name	Time	Method
No secondary outcome	Not applicable

Trial Locations

Locations (1)

Government Ayurveda College Hospital Tripunithura; 🇮🇳 Ernakulam, KERALA, India

Government Ayurveda College Hospital Tripunithura

🇮🇳Ernakulam, KERALA, India

Renuka K Raman

Principal investigator

9605500682

renukaraman333@gmail.com