An Observational, Randomized, open labelled, parallel group, two arm, study to evaluate safety and efficacy of Tab Nucart VG when compared with Glucosamine tablet in treatment of osteoarthritis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Mean change from baseline to subsequent visits and EOT visit in the WOMAC pain score.
研究概览
简要总结
The study is designed as a multicenter, open label, observational study. Subjects will be assigned to receive either Nucart – VG Tab or Glucosamine tablet. Parameters of WOMAC pain score, VAS scale and Quality of Life questionnaires will be assessed. Safety parameters like haematology and biochemistry will be assessed. AE/SAE will be recorded during the conduct of trial.investigator will evaluate whether the patient meets all the inclusion criteria and does not meet any of the exclusion criteria, to participate in the study. After signing informed consent form to determine the eligibility, investigator will investigate about the disease history, present signs and symptoms and treatment taken in past. Demographics (Age, Gender, height, weight (screening only)) and vital signs (Pulse Rate, Respiratory Rate, temperature, BP (At all visits)) will be recorded, X-ray and will be performed at screening. Local Laboratory Investigations: Blood sample (20.0 ml) will be collected at Screening for Hematology (Complete Blood count) and Biochemistry (RA Factor, SGPT, SGOT, serum Bilirubin). Urine Pregnancy test – All females who did not reach menopause will undergo a pregnancy test in local lab. After satisfying the eligibility criteria, investigator will perform detailed physical and systemic examinations and will give Patient a test request form for laboratory investigations i.e. X-Ray, CBC, UPT, SGPT and SGOT test. Based on these investigations, investigator will decide whether the patient is eligible to participate in the study. Study Duration is 90 days. Subject will consume either 1 tablet each twice daily after meals (1 tab of Boswellia serrata + 1 tab of Glucosamine sulphate) orally for 3 months or Glucosamine Tablet [750mg]1 tablet twice daily after meals for 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 45.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing to provide written informed consent and comply with study instructions for its duration.
- •Healthy male or non-pregnant female aged 45 to 65 years with a clinical symptom of Osteoarthritis.
- •Unilateral or bilateral osteoarthritis for more than 3 months
- •Symptoms for at least 6 months prior to screening.
- •Pain for 15 days of the preceding month (periarticular pain due to OA and not due to other conditions such as RA, bursitis, tendonitis, etc.).
- •Had an X-ray of the target joints taken no more than 1 year before baseline, showing evidence of OA with Kellgren-Lawrence grade 1-3 disease.
- •Females of child-bearing potential should have a negative serum pregnancy test prior to beginning therapy and agree to use adequate birth control during the study (acceptable methods include hormonal contraception maintained for a period of 3 months prior to the study and persisting through the study period, intrauterine device, barrier or abstinence).
排除标准
- •Recent injury in the area affected by osteoarthritis of the knee (past 4 months) and expectation of surgery in the next 4 months
- •History of secondary OA, rheumatoid arthritis, chronic inflammatory disease (e.g.,colitis) or fibromyalgia, underlying inflammatory arthropathy or severe rheumatoid arthritis
- •Hypersensitivity to non-steroidal anti-inflammatory drugs, abnormal liver or kidney function tests, history of peptic ulceration and upper Gastrointestinal hemorrhage, congestive heart failure, hypertension, hyperkalemia.
- •History of gastrointestinal bleeding or peptic ulcer disease.
- •Intra-articular corticosteroid injections within the preceding 3 months
- •Hyperuricemia (>440 μmol/l) and/or past history of gout
- •Major abnormal findings on complete blood count, history of coagulopathies, hematological or neurological disorders
- •Pregnant, breastfeeding, or planning to become pregnant during the studyObesity (body mass index > 30 kg/m2)
- •X-ray showing evidence of OA with Kellgren-Lawrence grade 4 disease.
- •Any other acute or chronic illness that in the opinion of the investigator could compromise the integrity of study data or place the patient at risk by participating in the study.
结局指标
主要结局
Mean change from baseline to subsequent visits and EOT visit in the WOMAC pain score.
时间窗: Mean change from Day 0 to subsequent visits and Day 90 visit in the WOMAC pain score. | ï‚· An improvement in pain and physical functions by using standard tools (Visual analog scale for pain, Western Ontario & McMaster Universities Osteoarthritis Index) at day 0 and day 90. | Quality of life questionnaire (EQ5D) at day 0 and day 90.
ï‚· An improvement in pain and physical functions by using standard tools (Visual analog scale for pain, Western Ontario & McMaster Universities Osteoarthritis Index)
时间窗: Mean change from Day 0 to subsequent visits and Day 90 visit in the WOMAC pain score. | ï‚· An improvement in pain and physical functions by using standard tools (Visual analog scale for pain, Western Ontario & McMaster Universities Osteoarthritis Index) at day 0 and day 90. | Quality of life questionnaire (EQ5D) at day 0 and day 90.
Quality of life questionnaire (EQ5D)
时间窗: Mean change from Day 0 to subsequent visits and Day 90 visit in the WOMAC pain score. | ï‚· An improvement in pain and physical functions by using standard tools (Visual analog scale for pain, Western Ontario & McMaster Universities Osteoarthritis Index) at day 0 and day 90. | Quality of life questionnaire (EQ5D) at day 0 and day 90.
次要结局
- All adverse events (AEs) will be reported at each visit to allow a comparison between treatment groups.(No of events occurring from screening to end of treatment)