Health Condition 1: M248- Other specific joint derangements,not elsewhere classified
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
Amazon Development Centre India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and Female subjectsâ?? in general good health. 2.Subjects in the age group 18-60 years (both the ages inclusive). 3.Subjects willing to give a written informed consent and agree to come for a regular follow up visit. 4.Subjects willing to abide by and comply with the study protocol. 5.Subjects who have not participated in a similar investigation in the past four weeks. 6.Healthy volunteers with no known allergy to any of the test ingredients as established by medical history
Exclusion criteria
Exclusion criteria: 1.Known history of hypersensitivity or intolerance to NSAIDs, aspirin, COX-2 inhibitors, and any other analgesic medicine. 2.Pregnant women, lactating women and women of child bearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy test 3.Non degenerative joint diseases or other joint degenerative diseases (musculoskeletal disorders) which will interfere with the evaluation of bone and joint health (Rheumatoid arthritis, active gout, recent joint trauma (target joint), or joint infection) 4.Subjects incapacitated or bound to wheel chair or bed and unable to carry out self-care activities 5.Treatment with intra-articular injection of corticosteroids into the knee within 3 months preceding study. 6.Ongoing treatment with anticoagulants, hydantoin, lithium, steroids, methotrexate and colchicine 7.Presence or history of active peptic ulcer in the preceding 6 months or bleeding ulcer at any time in the past. 8. Evidence of several renal, hepatic or hemopoiic disease or severe cardiac insufficiency as revealed by laboratory investigations. 9.Subjects with congestive heart failure 10.Subjects with hypertension 11.Clinically significant untreated hyperlipidaemia in context of a cardiovascular risk 12.History of having received any investigational drug or participated in any other clinical trial which ended in preceding month or currently ongoing. 13.Concurrent pain relieving medication such as antipyretics, analgesic, tranquilizers, hypnotics, excessive alcohol, NSAIDs, (Paracetamol & Tramadol are permitted in extreme pain) which would interfere with pain perception 14.Non-co-operative attitude of the volunteer 15.Any condition that in the opinion of the investigator does not justify the volunteerâ??s inclusion for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluating the sleep quality by standard questionnaire (Sleep Quality Index) â?¢ Evaluating the quality of activities of daily living by standard questionnaire (SF-6 questionnaire). â?¢ Evaluation of severity of the back pain (SF-MPQ-2). Timepoint: Day 0 to Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Evaluation of the product acceptance by the subjects for the regular use through a questionnaire. 2.Assessment for adverse events Timepoint: Day 0 to Day 28 | — |
Countries
India
Contacts
Public ContactMr Praveen ME
Radiant Research Services Pvt. Ltd
Outcome results
None listed