Integrative Ayurveda Healing Relieves Minor Sports Injury Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Pain; Sports Injury
• Intervention / Treatment: Device: Placebo; Device: Ayurveda

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Mahesana, Gujarat, India
      • NMP Medical Research Institute
  • Hariyana
    • Satnali, Hariyana, India
      • Khatri educational trust
  • Rajasthan
    • Jaipur, Rajasthan, India
      • Gyansanjeevani

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Device: Placebo
Experimental: Ayurveda	Device: Ayurveda; Ayurveda combinations in the form of gel and patches were applied on acute pain site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Pain intensity (VAS)	baseline to 3, 7 and 14 days

Collaborators and Investigators

• Sponsor: Adwin Life Care
• Collaborators: NMP Medical Research Institute
• Investigators: Principal Investigator: Archanaben Nachiket, MA, NMP Medical Research Institute; Study Director: Neha Sharma, PhD, NMP Medical Research Institute

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: March 1, 2015
• First Submitted That Met QC Criteria: March 4, 2015
• First Posted (Estimate): March 5, 2015

Study Record Updates

• Last Update Posted (Estimate): March 5, 2015
• Last Update Submitted That Met QC Criteria: March 4, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Acute pain; Ayurveda; Sports Injury
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Acute Pain; Athletic Injuries
• Other Study ID Numbers: Adwin021