Clinical trial to test the efficacy and safety of topical application of IP in management of pain associated with muscles
Completed
- Conditions
- Acquired deformity of musculoskeletal system, unspecified,
- Registration Number
- CTRI/2019/11/021874
- Lead Sponsor
- Vasu Healthcare Pvt Ltd
- Brief Summary
This study is aprospective, open label, single-center 14 days Clinical Study to evaluate theefficacy and Safety of Test formulation (Polyherbal Pain ReliefOintment) in the management of Moderateto severe pain.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- 1.Subjects of both genders with age ≥ 18 years. 2. Subjects who are willing to give written Informed Consent and willing to follow study procedures. 3.Subjects agreeing not to use any treatment for pain apart from the IP. 4. Subjects with documented diagnosis of moderate to severe pain with any of the condition, i.e., a.Sprains b.Shoulder and neck stiffness c.Backache d.Miscellaneous Musculo.
- skeletal pain not classified above 5.Acute back pain, acute neck pain, acute musculoskeletal pain with no underlying pathology 6.Moderate to severe pain, as defined by an average 7-day pain score of greater than 4.0 on an 11-point numerical rating scale for pain intensity (NRS-PI). 7.All concurrent medications taken for any reason stable for 14 days.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change Visual Analog Scale (VAS) score at Baseline and on day 1, 2, 3 and 7. 7 days 2. Change in NPRS score at baseline and on Day 1, 2, 3 and 7. 7 days
- Secondary Outcome Measures
Name Time Method 1.Patient compliance questionnaire 2.Any AE or SAE
Trial Locations
- Locations (2)
KIMS
🇮🇳Khordha, ORISSA, India
Santosh Hospital
🇮🇳Bangalore, KARNATAKA, India
KIMS🇮🇳Khordha, ORISSA, IndiaDr Shubhransu PatroPrincipal investigator9861056729dr.shubhransu@gmail.com