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Integrative Ayurveda Healing Relieves Minor Sports Injury Pain

Primary Purpose

Acute Pain, Sports Injury

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Ayurveda
Placebo
Sponsored by
Adwin Life Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring Ayurveda, Acute pain, Sports Injury

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • NMP Medical Research Institute
  • Khatri educational trust
  • GyanSanjeevani

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ayurveda

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in Pain intensity (VAS)

Secondary Outcome Measures

Full Information

First Posted
March 1, 2015
Last Updated
March 4, 2015
Sponsor
Adwin Life Care
Collaborators
NMP Medical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02380989
Brief Title
Integrative Ayurveda Healing Relieves Minor Sports Injury Pain
Official Title
Integrative Ayurveda Healing Relieves Minor Sports Injury Pain:Results of a Multicenter Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adwin Life Care
Collaborators
NMP Medical Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain, Sports Injury
Keywords
Ayurveda, Acute pain, Sports Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
210 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ayurveda
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Ayurveda
Intervention Description
Ayurveda combinations in the form of gel and patches were applied on acute pain site.
Intervention Type
Device
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in Pain intensity (VAS)
Time Frame
baseline to 3, 7 and 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Archanaben Nachiket, MA
Organizational Affiliation
NMP Medical Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neha Sharma, PhD
Organizational Affiliation
NMP Medical Research Institute
Official's Role
Study Director
Facility Information:
Facility Name
NMP Medical Research Institute
City
Mahesana
State/Province
Gujarat
Country
India
Facility Name
Khatri educational trust
City
Satnali
State/Province
Hariyana
Country
India
Facility Name
GyanSanjeevani
City
Jaipur
State/Province
Rajasthan
Country
India

12. IPD Sharing Statement

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