Health Condition 1: M179- Osteoarthritis of knee, unspecified
Conditions
Interventions
None listed
Sponsors
Emami Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult Participants, Male or female between 30-65 years of age 2.Participants with a score of 4 or more on the Visual Analogue Score (VAS) 3.Participants with Osteoarthritis Index(WOMAC) more than 0 4.Participants with symptoms consistent with generalized pain or OA for at least six months prior to screening. 5. Participants who are continuing any NSAIDS or other analgesic medication taken for any other condition including current generalized pain. 6.Participants with non-significant safety profile of blood (CBC, Liver and Kidney) 7.Participants with a documented history of musculoskeletal pain and inflammation, consistent with generalized pain and/or osteoarthritis, persisting for a duration of 6 months or more prior to screening The condition should be stable, not requiring hospitalization, and classified as chronic musculoskeletal pain. 8.Participants willing to give voluntary informed consent 4.Participants with symptoms consistent with generalized pain or OA for at least six months prior to screening. 5. Participants who are continuing any NSAIDS or other analgesic medication taken for any other condition including current generalized pain. 6.Participants with non-significant safety profile of blood (CBC, Liver and Kidney) 7.Participants with a documented history of musculoskeletal pain and inflammation, consistent with generalized pain and/or osteoarthritis, persisting for a duration of 6 months or more prior to screening The condition should be stable, not requiring hospitalization, and classified as chronic musculoskeletal pain. 8.Participants willing to give voluntary informed consent
Exclusion criteria
Exclusion criteria: 1.Participants with acute muscle spasms who need parenteral therapy, surgery or hospital admission for management. painful uncomplicated acute soft tissue injury of the upper or lower extremity, including acute injuries of ligaments, tendons, or muscles. Subjects with Grade 2 & 3 sprain or strain. 2.Participants having history of Blood and lymphatic system disorder, cardiac disorder apart from hypertension, congenital familial and genetic disorder, immune system disorder, neoplasms benign, malignant and unspecified disorder, psychiatric disorder, Renal, urinary disorder and autoimmune diseases an active infectious disease (HBV, HCV, HIV) which in the opinion of the investigator would influence the conduct and outcomes of the study. 3.Participants with any other type of arthritis other than osteoarthritis (eg rheumatoid arthritis, gouty arthritis, psoriatic arthritis, etc.) 4.Participants with uncontrolled hypertension (Diastolic bloodHJ pressure more than or equal to 110 mmHg and/or systolic blood pressure; more than or equal to 180 mmHg). 5.Use of any oral or topical analgesic, antipyretic, sedative, anti-inflammatory, muscle relaxants or any other oral or topical medications which in the opinion of the investigator would influence the conduct and outcomes of the study. 6.Prior use within 1 week of study any Ayurvedic, siddha, Unani or proprietary products for pain and inflammation. 7.Any kind of neuralgic pain, headache and/or chronic pain. 8.Previous adverse reaction or known allergy to herbal, NSAID, steroids or any other severe food allergies. 9.A known pregnancy or lactation 10.Previous history of gastro-intestinal hemorrhage or perforation, active or recurrent peptic ulceration or peptic bleeding or Scheduled elective surgery or other invasive procedures during the period of study participation. 11. Participants who are severe smokers and drinkers. 12.Received an investigational or product or participated in an investigational study within a period of 30 days prior to receiving study medication. 13.A current diagnosis or a history of relevant depressive episodes or of panic attacks, psychosis, bipolar or eating disorders. 14. History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the Investigator or Sponsor physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change from Baseline in Visual Analogue Scale (VAS) For Assessment of Generalized Pain to end of the treatment and Follow-up visit 2.Change from Baseline in The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): [scale of difficulty: 0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely] to end of the treatment and Follow-up visitTimepoint: Timeframe - Baseline, Day - 15, Day - 30, Day - 45 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in inflammatory Biomarker (ESR & CRP) to end of the treatment Monitoring and recording of all adverse events (AEs) and serious adverse events Assessment of long-term effects and recovery progress of osteoarthritis treatment Change from Baseline in Kellgren-Lawrence classification systemTimepoint: Time frame - Baseline, Day-15 Day-30, Day-45 | — |
Countries
India
Contacts
Public ContactYogendra Kumar Choudhary
Saveetha Medical College and Hospital SIMATS
Outcome results
None listed