Integrative Ayurveda Healing Relieves Minor Sports Injury Pain

Acute Pain Clinical Trial

Official title:

Integrative Ayurveda Healing Relieves Minor Sports Injury Pain:Results of a Multicenter Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02380989
• Other study ID #: Adwin021
• Status: Completed
• Phase: Phase 2
• First received: March 1, 2015
• Last updated: March 4, 2015
• Start date: September 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Adwin Life Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Sports-related soft tissue injuries, such as sprains, strains, and contusions, are a common painful condition. Current treatment includes oral nonsteroidal anti-inflammatory drugs (NSAIDs), which have a high incidence of intolerable gastrointestinal side effects.

Ancient Indian healing system, Ayurveda addresses the need of sports medicine up to certain extent. In practice, there are different treatment modalities for injuries, uses of drugs & dietetics as well as practices of rehabilitation. Although, previous evidences support the efficacy of ayurveda practices with significant reduction in pain, joint tenderness, joint swelling, mobility restriction and early morning joint stiffness. But there is no treatment studies have been performed to evaluate the clinical outcome for specific sports injuries.

This study assessed the efficacy and safety of ayurveda gel and patches applied to the painful injury site for the treatment of acute minor sports injury pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• inversion ankle injury;

• injury sustained during sporting activity

Exclusion Criteria:

• other lower limb injury;

• concurrent fracture with or without dislocation or with or without complete rupture;

• surgery for ankle injury.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain
• Athletic Injuries
• Sports Injury

Intervention

Device:
• Ayurveda
Ayurveda combinations in the form of gel and patches were applied on acute pain site.
• Placebo

Locations

Country	Name	City	State
India	GyanSanjeevani	Jaipur	Rajasthan
India	NMP Medical Research Institute	Mahesana	Gujarat
India	Khatri educational trust	Satnali	Hariyana

Sponsors (2)

Lead Sponsor	Collaborator
Adwin Life Care	NMP Medical Research Institute

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain intensity (VAS)		baseline to 3, 7 and 14 days	No