Health Condition 1: M628- Other specified disorders of muscle
Conditions
Interventions
None listed
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion criteria
Inclusion criteria: 1)Adult male and female participants aged between18-65 years. 2)Participants presenting with mild to moderate pain (Pain score 1-6 based on VAS (Appendix I)) due to known musculoskeletal conditions like Cervical and lumbar spondylosis, sciatica, carpal tunnel syndrome, tennis elbow, chronic joint pain, joint immobility, chronic muscle pain, Sprains, Strains, etc. Note: If participants have pain in multiple locations, only one location will be considered for the assessment by the investigator. 3)Participants who have not participated in any other similar clinical study in the last one month. 4)Participants willing to sign informed consent and follow the study procedure. 5)Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, throughout the duration of study participation. Note: A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: a)Has not undergone a hysterectomy or bilateral oophorectomy; or b)Has not attained menopause (Women not menstruating for at least 12 consecutive months).
Exclusion criteria
Exclusion criteria: 1)Participants with severe musculoskeletal conditions (bruises, trauma, muscle damage, raw wounds, fractures, hematoma etc.). 2)Participants who are on any regular pain killers or have used any oral or topical pain killers (NSAIDs, opioid analgesics, steroid medication, muscle relaxant, herbal etc.) in the past 24 hours prior to screening. 3)Participants who are not willing to refrain from using any other similar topical applications during the study period. 4) Any known generalized skin conditions, condition that prevents easy application of the test product (disorders, presence of open wounds etc.). 5)Participants with known clinically significant neurological, respiratory, cardiovascular, gastrointestinal, hepatic, congenital or any other chronic disorder that can interfere with the study conduct in the opinion of the Investigator. 6)Participants with known history or present condition of allergic response to any of the ingredients in the investigational product. 7)Pregnant as assessed by UPT & History of Amenorrhea and lactating women. 8)Known history of drug abuse/dependency that would limit ability to comprehend or follow instructions related to informed consent, treatment instructions, study procedures or follow-up guidelines. 9)Any other conditions (physical, psychological, social or uncontrolled dietary measures) that can interfere with the participant s compliance to the study in the opinion of the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Endpoints Time required for the onset of pain relief Time required for next/successive application (lasting pain relief) Reduction in pain, swelling, tenderness, redness, muscle stiffness and immobility based on Visual Analogue Scale (VAS). Product feedback questionnaireTimepoint: Day 1, Day 5 and Day 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Endpoints 1. General Physical and Vital Signs. 2. Local intolerance (Appendix-II) 3. Adverse event assessmentTimepoint: Day 1, Day 5 and Day 14. | — |
Countries
India
Contacts
Public ContactDr Soorya Narayan H
Himalaya Wellness Company
Outcome results
None listed