Health Condition 1: null- Musculoskeletal Pains
Conditions
Interventions
Intervention1: NHPL/OZ-01 Ayurvedic Formulation: 50 ml liquid orally once daily
Duration of study: 30 days
Control Intervention1: N/A: N/A
Sponsors
NuZen Herbal Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects of either sex 2. Age above 18 years 3. Willing to give written consent 4. Subjects suffering from Musculoskeletal pains: Myalgia, Neck pain, limb pain, low back pains, Joint Pains, Stiffness and Wide spread musculoskeletal pains. 5. Pain score of at least 4 cm on a 10-cm linear visual analogue scale
Exclusion criteria
Exclusion criteria: 1 Contraindications or Hypersensitivity to the active substances or to any of the excipients of the drug. 2 Subjects currently on any other NSAID therapy. 3 History or presence of any medical condition or disease according to the discretion of the Investigator. 4 History of significant renal or hepatic problems / abnormal functions. 5 History of significant asthma, urticaria or other allergic reactions 6 History of significant gastric and/or duodenal ulceration such as Mal-absorption syndrome. 7 History of diabetes, coronary artery disease and hypertension with or without complication 8 History of any chronic physical, hormonal, immune or psychiatric illness 9 Currently taking any herbal preparations 10 Individuals refusing to use appropriate non-hormonal birth control measures. 11 Subjects participating in any other trial. 12 Female subjects found positive in urine pregnancy test. 13 Lactating Mothers 14 Subjects not willing to comply with protocol requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?? At least 50% improvement on the VAS (Visual analogous score) pain from Baseline visit to after Visit 2 & Visit 3 of treatmentTimepoint: Screening,Baseline,Day 10,End of the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| â?? Safety will be assessed from the number of adverse events occurred and judging their causal relationship to the study drugTimepoint: Screening,Baseline,Day 10,End of the treatment | — |
Countries
India
Contacts
Public ContactMs Sujata A
NuZen Herbal Private Limited
Outcome results
None listed