Health Condition 1: null- In Patients with Arthritis
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Akums Drugs and Pharmaceuticals
Mudra Clincare
Eligibility
Inclusion criteria
Inclusion criteria: 1 Patients already diagnosed with arthritis (Rheumatoid arthritis or Osteoarthritis), at least 6 months before to screening. 2 Patients (male and female) having arthritis pain with VAS score up to 7 (mild to moderate pain). 3 Patients with Health Assessment Questionnaire Disability Index (HAQ-DI) score between 0-2 for each question. (See annexure III) 4 Patients who are able to and willing to provide written informed consent. 5 Co-operative and understanding skills. 6 Patients willing and assessed to be able to participate in all aspects of the core study, including administration of intramuscular injection in the gluteal region, completion of evaluations, and compliance with protocol requirements.
Exclusion criteria
Exclusion criteria: 1 Hypersensitivity to the drugs components or other drug from same class. 2 Patient unable to refrain from alcohol, psychoactive drugs, and sedatives including sleeping preparations (e.g. benzodiazepines) for the duration of their participation in the study 3 Patient with history of drug of abuse. 4 Patients at risk for respiratory depression, patients with increased intracranial pressure or head injury, suffering from severe headache 5 Patients recently faced any viral or bacterial infection. 6 Patients have received any biological disease modifying anti rheumatic drugs (eg. Methotrexate, Cyclosporine etc.) 7 Any psychiatric diseases (including major depression), epilepsy, blood disorders like porphyria. 8 Patients under treatment for chronic allergy. 9 Clinical evidence of immunosuppression. 10 Having participated in other clinical trial less than one year prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the change in the VAS scale scoreTimepoint: From baseline to 4 hours after the administration of drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants reporting adverse eventsTimepoint: After the administration of drug.;Number of participants reporting presence of other parameters such as hypotension, tachycardia, bronchospasm and urticariaTimepoint: At 2 minutes, 5 minutes, 10 minutes, 60 minutes, and 240 minutes after administration of the drug.;Number of participants reporting ThrombophlebitisTimepoint: After the administration of drug. | — |
Countries
India
Contacts
Public ContactDr Harshad Dabhade
Mudra Clincare
Outcome results
None listed