Integrative Ayurveda Healing Relieves Minor Sports Injury Pain
1 other identifier
interventional
210
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2014
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 1, 2015
CompletedFirst Posted
Study publicly available on registry
March 5, 2015
CompletedMarch 5, 2015
March 1, 2015
2 months
March 1, 2015
March 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Pain intensity (VAS)
baseline to 3, 7 and 14 days
Study Arms (2)
Ayurveda
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- inversion ankle injury;
- injury sustained during sporting activity
You may not qualify if:
- other lower limb injury;
- concurrent fracture with or without dislocation or with or without complete rupture;
- surgery for ankle injury.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Adwin Life Carelead
- NMP Medical Research Institutecollaborator
Study Sites (3)
NMP Medical Research Institute
Mahesāna, Gujarat, India
Khatri educational trust
Satnāli, Haryana, India
GyanSanjeevani
Jaipur, Rajasthan, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Archanaben Nachiket, MA
NMP Medical Research Institute
- STUDY DIRECTOR
Neha Sharma, PhD
NMP Medical Research Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2015
First Posted
March 5, 2015
Study Start
September 1, 2014
Primary Completion
November 1, 2014
Study Completion
December 1, 2014
Last Updated
March 5, 2015
Record last verified: 2015-03