CTRI/2021/11/038256
Not yet recruiting
Phase 3
An Open-label, Single-arm clinical study to evaluate the Efficacy and Safety of Rumalaya Cream in common Musculoskeletal conditions
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue
- Sponsor
- Himalaya Wellness Company
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Subjects of either gender aged \>\=18 \- \<\=65 years.
- •2\.Subjects presenting with pain due to common musculoskeletal conditions inclusive of any of the below:
- •a Joints pain,
- •b Neck pain inclusive of Cervical spondylosis
- •c Shoulder pain inclusive of Frozen Shoulder
- •d Low back pain inclusive of Lumbar spondylosis
- •e Muscular pain
- •f Muscular sprain.
- •3\.Subjects who are willing to refrain any topical applications during the study period.
- •4\.Subjects who are not on NSAIDs in the past 24 hours prior to screening.
Exclusion Criteria
- •1\.Subjects suffering from auto\-immune disorders, spastic disorders, genetic disorders and severe traumatic conditions.
- •2\.Any evidence or history of hypersensitivity to any of the components in the Rumalaya cream.
- •3\.Any known skin disorder or presence of open wounds.
- •4\.Subjects who are on opioid analgesics and steroid medication will be excluded.
- •5\.Clinical diagnosis of bruises, trauma, muscle damage.
- •6\.Subjects with raw wounds, sutures, fractures and hematoma.
- •7\.Pregnant or lactating women/women not willing to follow adequate standard contraceptive measures.
Outcomes
Primary Outcomes
Not specified
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