An open labelled randomized study to compare the efficacy and safety of oral dose of Glucosamine HCl Tablet SR (Medreich) with Glucosamine HCl Tablet in patients with Osteoarthritis.

Medreich Steri Lab P Ltd0 个研究点目标入组 50 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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.

•?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.

发起方

Medreich Steri Lab P Ltd