Health Condition 1: M959- Acquired deformity of musculoskeletal system, unspecified
Conditions
Interventions
None listed
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adults aged 18 to below 65 years. 2.Diagnosed with one of the following conditions with mild to moderate pain: Osteoarthritis Rheumatoid arthritis Gout Spondylosis Other chronic joint pain (e.g., Frozen Shoulder, Tennis Elbow) 3.Pain score between 1 to 6 on the Numerical Rating Scale (NRS). (Only the most painful site will be considered if multiple sites are involved.) 4.No use of other medicines or supplements for the condition 10 days before screening and during the study. 5.Women of childbearing age and men with such partners must use effective birth control during the study. 6.Men must not donate sperm from the start of the study until 90 days after it ends. 7.Not part of any other clinical study in the last 3 months. 8.Willing to sign informed consent and follow study procedure.
Exclusion criteria
Exclusion criteria: 1.Severe joint pain or recent injury causing immobility 2.Requires injections, surgery, or hospitalization 3.Severe back pain with disc or nerve issues such as sciatica 4.History of joint replacement or mobility-limiting hip or back pain 5.Use of steroids, DMARDs, or joint injections in the past six months 6.Physical disability affecting study assessments 7.History of gastrointestinal bleeding, ulcers, or perforation 8.Active gastrointestinal issues such as GERD or gastritis with GSRS score greater than one 9.Major health conditions such as heart, liver, neurological, or congenital disorders 10.Participants with HbA1c levels equal to or greater than eight percent, indicating uncontrolled diabetes, will be excluded from the study 11.Drug abuse or inability to follow study instructions 12.Pregnant or breastfeeding women 13.Allergy to study product ingredients 14.Any condition affecting study compliance as determined by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All Participants â?¢Change in 24-hour Average pain intensity (Baseline24hr-EOS24hr) through NRS. â?¢Participants with 50 percent or more improvement â?¢Pain at rest and motion â?¢Tenderness and swelling (not for spondylosis) â?¢Quality of life improvement â?¢Rescue medication usage Rheumatoid Arthritis â?¢Morning stiffness duration â?¢Grip strength â?¢Tender joint count Osteoarthritis â?¢Chair stand test â?¢Stair climb test â?¢Fast-paced walk test â?¢Range of motion (also for spondylosis) Timepoint: Day 0, Day 7, & Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy study: â?¢Assessment of GI (Gastrointestinal) tolerability â?¢Incidence of adverse events Timepoint: Efficacy study: Day 0, Day 7, Day 28 ;Extended Safety Study: â?¢GI (Gastrointestinal) tolerability throughout the study. â?¢Incidence of adverse events throughout the study.Timepoint: Extended Safety Study Day 0, Day 56 | — |
Countries
India
Contacts
Public ContactDr Soorya Narayan H
Himalaya Wellness Company
Outcome results
None listed