Acute PainPhase 2NCT02380989
Integrative Ayurveda Healing Relieves Minor Sports Injury Pain
A Phase 2 study testing Ayurveda in people with Acute Pain and Sports Injury, run by Adwin Life Care at 3 sites in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain, Sports Injury
- What is being tested?
- Ayurveda
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 3 sitesIndia
- Study dates
- Sep 2014to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- inversion ankle injury;
- injury sustained during sporting activity
Who cannot join
- other lower limb injury;
- concurrent fracture with or without dislocation or with or without complete rupture;
- surgery for ankle injury.
Trial locations and contacts
3 sites in 1 country.
India3 sites
GyanSanjeevani
Jaipur, Rajasthan
NMP Medical Research Institute
Mahesāna, Gujarat
Khatri educational trust
Satnāli, Haryana
About this study
Official title: 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.
- Conditions
- Acute Pain, Sports Injury
- Being tested
- Ayurveda, Placebo
- Keywords
- Ayurveda, Acute pain, Sports Injury
- Medical subject headings
- Acute Pain, Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AyurvedaDevice
Ayurveda combinations in the form of gel and patches were applied on acute pain site.
PlaceboDevice
| Study group | Role | What they receive |
|---|---|---|
| Ayurveda | Experimental | Not described Receives: Device: Ayurveda |
| Placebo | Placebo comparator | Not described Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain intensity (VAS)
Measured: baseline to 3, 7 and 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startSep 2014
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adwin Life Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NMP Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Archanaben Nachiket, MA, Principal investigator, NMP Medical Research InstituteNeha Sharma, PhD, Study director, NMP Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380989
- Sponsor's protocol ID
- Adwin021
- Status last verified
- Mar 2015
- First submitted
- 1 Mar 2015
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Ayurveda Healing Relieves Minor Sports Injury Pain:Results of a Multicenter Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02380989
- Acronym / sponsor ID
- Adwin021
- Conditions
- Acute Pain, Sports Injury
- Keywords
- Ayurveda, Acute pain, Sports Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Adwin Life CareIndustry (pharma, biotech, devices)
- Collaborators
- NMP Medical Research Institute
- Study start
- Sep 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ayurveda | Experimental | Device: Ayurveda |
| Placebo | Placebo comparator | Device: Placebo |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- inversion ankle injury;
- injury sustained during sporting activity
Key exclusion criteria (3 listed)
- other lower limb injury;
- concurrent fracture with or without dislocation or with or without complete rupture;
- surgery for ankle injury.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AyurvedaAyurveda combinations in the form of gel and patches were applied on acute pain site. | Device | Ayurveda |
| Placebo | Device | Placebo |
Primary outcome
Change in Pain intensity (VAS)
Time frame: baseline to 3, 7 and 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Archanaben Nachiket, MA principal investigator
NMP Medical Research Institute
Neha Sharma, PhD study director
NMP Medical Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ayurveda in people with Acute Pain and Sports Injury, run by Adwin Life Care at 3 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain intensity (VAS) (time frame: baseline to 3, 7 and 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015.