To know the effect of Rumalaya cream in common muscular pain

An Open-label, Single-arm clinical study to evaluate the Efficacy and Safety of Rumalaya Cream in common Musculoskeletal conditions

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/11/038256

Enrollment

Registered

2021-11-25

Start date

Unknown

Completion date

Unknown

Last updated

2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M00-M99- Diseases of the musculoskeletal system and connective tissue

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects of either gender aged >=18 - 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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
â?¢Time required for the onset of relief. â?¢Time required for complete relief of pain. â?¢Time required for next/successive application Timepoint: maximum of 5 applications in 24 hours	—

Secondary

Measure	Time frame
â?¢Percentage of subjects showing improvement in VAS on painas compared to baseline. â?¢Reduction in swelling, tenderness, muscle stiffness and mobility (Based on VAS scale) â?¢Incidence of any adverse events during study Timepoint: maximum of 24 hours	—

Countries

India

Contacts

Public ContactDr Soorya Narayan H

Himalaya Wellness Company

dr.srikrishna@himalayawellness.com

Outcome results