Clinical trial to test the efficacy and safety of topical application of IP in management of pain associated with muscles

Not Applicable

Completed

• Conditions: Health Condition 1: M959- Acquired deformity of musculoskeletal system, unspecified

• Registration Number: CTRI/2019/11/021874
• Lead Sponsor: Vasu Healthcare Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2020-02-03
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 114

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. <br/ ><br>2. Change in NPRS score at baseline and on Day 1, 2, 3 and 7. <br/ ><br>Timepoint: 7 days <br/ ><br> <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.Patient compliance questionnaire <br/ ><br>2.Any AE or SAETimepoint: 7 Days