To know the effect of Rumalaya cream in common muscular pai
- Conditions
- Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- CTRI/2021/11/038256
- Lead Sponsor
- Himalaya Wellness Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
5.Subjects willing to sign informed consent and follow with the schedule of the study.
6.Subjects who have not participated in similar kind of study in last 4 weeks.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Time required for the onset of relief. <br/ ><br>â?¢Time required for complete relief of pain. <br/ ><br>â?¢Time required for next/successive application <br/ ><br>Timepoint: maximum of 5 applications in 24 hours
- Secondary Outcome Measures
Name Time Method â?¢Percentage of subjects showing improvement in VAS on painas compared to baseline. <br/ ><br>â?¢Reduction in swelling, tenderness, muscle stiffness and mobility (Based on VAS scale) <br/ ><br>â?¢Incidence of any adverse events during study <br/ ><br>Timepoint: maximum of 24 hours