Integrative Ayurveda Healing Relieves Minor Sports Injury Pain

NCT ID: NCT02380989

Last Updated: 2015-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Pain Sports Injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ayurveda

Group Type EXPERIMENTAL

Ayurveda

Intervention Type DEVICE

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ayurveda

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

Intervention Type DEVICE

Placebo

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

NMP Medical Research Institute

OTHER

Sponsor Role collaborator

Adwin Life Care

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Archanaben Nachiket, MA

Role: PRINCIPAL_INVESTIGATOR

NMP Medical Research Institute

Neha Sharma, PhD

Role: STUDY_DIRECTOR

NMP Medical Research Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

NMP Medical Research Institute

Mahesāna, Gujarat, India

Site Status

Khatri educational trust

Satnāli, Haryana, India

Site Status

GyanSanjeevani

Jaipur, Rajasthan, India

Site Status

Countries

Review the countries where the study has at least one active or historical site.

India

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Adwin021

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cold Water Immersion and Recovery
NCT02596542 COMPLETED NA