Health Condition 1: M199- Osteoarthritis, unspecified site
Conditions
Interventions
None listed
Sponsors
Rasraj Ayurvedic Pharmacy
Eligibility
Inclusion criteria
Inclusion criteria: -Participants between the age group of 18- 70 years of both sex have to be selected for the study. -Diagnosed with one of the following 1.Participants with rheumatoid arthritis 2.Participants with back pain of more than three months duration 3.Participants with joint pain due to osteoarthritis 4.Obese patients with arthritis having a body mass index of thirty kilogram per meter square or more -Participants must have a Visual Analogue Scale score between 4 and 8 on a 0 to 10 scale at screening or baseline -Participants must have a baseline Health Assessment Questionnaire Disability Index score between point 0.5 and 2.0 -Participants must be able and willing to provide written informed consent and comply with the study requirements
Exclusion criteria
Exclusion criteria: -Pregnant and lactating mothers -Participants with a history of knee or hip joint replacement surgery or any hip or back pain that interferes with ambulation -Participants with an expectation of undergoing surgery during the study period -Participants with illnesses that may interfere with the investigatorâ??s interpretation of study results -Participants with uncontrolled diabetes hypertension symptomatic congestive heart failure unstable angina pectoris or history of myocardial infarction -Participants who have participated in another clinical drug trial within three months prior to recruitment -Participants with current active alcohol or drug abuse or a history of alcohol or drug abuse within twenty four weeks prior to baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain intensity from baseline to end of study Day 60 as measured by the Visual Analogue Scale VAS where 0 indicates no pain and 10 indicates worst possible pain.Timepoint: Screening & Baseline (Day 0) Follow-up (Day 30 ± 3 days) End of Study(Day 60 ± 3 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in functional ability from baseline to Day 60 assessed using the Health Assessment Questionnaire Disability Index HAQ DITimepoint: Screening & Baseline (Day 0) Follow-up (Day 30 ± 3 days) End of Study(Day 60 ± 3 days) | — |
Countries
India
Contacts
Public ContactMs Mamatha B Gokavi
Samahitha Research Solutions
Outcome results
None listed