None listed
Conditions
Interventions
Intervention1: Glucosamine Hydrochloride SR: 1500mg, od for 2 months
Control Intervention1: Glucosamine Hydrochloride Regular: 1500mg, od for 2 months
Sponsors
Medreich Steri Lab P Ltd
Eligibility
Inclusion criteria
Inclusion criteria: All patients proven to be normal after screening for biochemical investigations indicated in the enclose CRF ?Willingness to provide informed consent to participate in the study. ?Patients of either gender within the age limit 40 and above ?Proven diagnosis of OA confirmed clinically or radiographically. ?Renal & liver function parameters to be normal. ?Patients with at least 35 mm pain in the target joint for at least 15 days in a month on a Visual Analogue Scale. ?American Rheumatism Association functional class - I, II and III.
Exclusion criteria
Exclusion criteria: ? History / evidence of allergy or hypersensitivity to glucosamine or other related drugs ? Renal or liver impairment ? History of uncontrolled diabetes (GRBS>200mg/dl) / asthma/ uncontrolled Hypertension ? History or current gastro-intestinal diseases influencing drug absorption, except for appendectomy. ? History within 3 months of drug abuse (including benzodiazepines, opioids, cocaine, THC and amphetamine etc.) ? History of alcoholism (more than two years), moderate drinkers (more than three drinks per day) or having consumed alcohol within 48 hours prior to dosing [one drink is equal to one unit of alcohol (one glass wine, half pint beer, one measure of spirit)] ? High caffeine (more than 5 cups of coffee or tea/day) or tobacco (5 or more packets of gutka per day) consumption. ? Consumption of grapefruit juice and poppy containing foods within 48 hours prior to clinic visit. ? Participation in any clinical trial in the last three months. ? Evidence of active peptic ulcer within the last 6 months. ? Clinical evidence or known history of severe Cardiac, Pulmonary, Gastrointestinal, Renal, Hepatic or Neurological disorders. ? History of allergy to aspirin or NSAIDs. ? Likelihood of Orthopaedic surgery during the study. ? Patient with infectious arthritis or gout. ? Pregnant & lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improving quality of life [QOL] in subjects in relation to VAS and functional level score.Timepoint: Each 15 days for 2 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical improvement. Any serious adverse event / adverse drug reactionTimepoint: Each 15 days for 2 months. | — |
Countries
India
Contacts
Public ContactDr Chanda Kulkarni
St.John's medical College
Outcome results
None listed