Randomized, parallel arm, controlled clinical trial to evaluate the efficacy and safety of HFPM-01 in improving pain, stiffness and inflammation in patients suffering from knee osteoarthritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Proportion of subjects requiring analgesics as rescue medication
研究概览
简要总结
Osteoarthritis is the second most common rheumatologic problem and it is the most frequent joint disease with a prevalence of 22% to 39% in India. The present study is planned to validate clinical safety and efficacy of HFPM-01, in osteoarthritis. It is high-quality products with the amalgamation of highest quality standards followed with the traditional knowledge of the selection of ingredients. By virtue of the ingredients used and the product development with quality standards, it can prove efficacious in the management of symptoms of osteoarthritis as well as improving quality of life and offering gastroprotection.
A randomized, parallel arm, controlled clinicaltrial was conducted to evaluate the efficacy and safety of HFPM-01 in improvingpain, stiffness and inflammation in patients suffering from kneeosteoarthritis. Ninety patients of either sex in the age group of 40 to 70years with clinical and radiological evidence of osteoarthritis were selectedfor the trial. The patients were randomly divided into three groups. Group Apatients received HFPM-01 at a dose of 1 tablet thrice daily, and Group Breceived Glucosamine sulphate 500 mg trice a day and group 3 received NSAIDS asper requirement to manage symptoms. If needed the analgesics were offered tosubjects from test and glucosamine group as a rescue.
All symptoms along with severity and durationwere recorded prior to the drug treatment. Routine blood chemistry along withinflammatory marker CRP were done before and at the end of the treatment periodto assess any changes. Patients were followed up every 4 weeks for 3 months.
Symptomatic assessment was carried out at day7, day 15, Day 30, 60 and 90. It was evident from the fact that onset of relieffrom the pain and stiffness was started from 7th day as per subjectreported scale.
The pain, inflammation and stiffness wasassessed through WOMAC questionnaire, it was found from the data that there was33, 39.7 and 3.5% decrease in WOMAC score from baseline to day 90 in HFPM-01,Glucosamine and Placebo group respectively. There was significant decrease inWOMAC score after treatment with HFPM-01 and Glucosamine.
The % reduction in Visual Assessment Score forpain was 53.16, 55.22 % decrease in VAS score from baseline to day 90 inHFPM-01 and Glucosamine group respectively. In case of placebo group there was20% increase in VAS pain score. There was significant decrease in VAS scoreafter treatment with HFPM-01 and Glucosamine.
There was significantly improved quality oflife of subjects after treatment with HFPM-01 and Glucosamine.
The symptoms of arthritis like Morningstiffness, tiredness, tenderness, muscle spasm, swelling were reducedsignificantly after treatment of HFPM-01 and Glucosamine.
The joint flexibility and weight bearingcapacity was improved after treatment of HFPM-01 and Glucosamine.
Serum CRP levels were measured in all thegroups. Serum CRP levels were raised in subjects at baseline. In HFPM-01 treatedgroup, serum CRP levels were reduced by 30% at end of study when compared toplacebo. When compared to % reduction of serum CRP between HFPM-01 andglucosamine treated group
Subjects experiencing GI symptoms likeheartburn and constipation were relieved of these symptoms in HFPM-01 treatedgroup by the virtue of gastro protective action and effect of reduced intake ofNSAIDS required for management of pain for 3 months. The gastro protectiveactivity was better in HFPM-01 treated group than Glucosamine and placebotreated groups.
Total of 15% of population of HFPM-01 treatedgroup, 25% of Glucosamine and 40% in control group used NSAID as a rescuemedication during 90 days period. There was reduction in requirement of NSAIDin managing pain.
There was significant reduction in CRP levelsin HFPM-01 treated group compared to control group. This could explain theanti-inflammatory potential of HFPM-01.
90% of HFPM-01 treated group and 50% inglucosamine treated group were satisfied with the drug and showed significantimprovement in the symptoms and mobility. In control group only few patientsexpressed their satisfaction to relief in pain. No adverse events related tothe HFPM-01 use were reported by any of the patients.
HFPM-01 presented better management of pain relatedstress reported by subjects.
HFPM-01 improved joint comfort and mobility. Itsignificantly improved muscular energy and vitality thus overall quality oflife.
The investigational product HFPM-01 found to besafe and effective in management of osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex, 40 to 70 years of age Diagnosis of OA knees, based on typical history, clinical presentation, findings and fulfilling the ACR classification criteria for OA knees, (Patients presenting knee osteoarthritis together with pain at shoulder, back and muscle spasm will be preferred) A minimum pain VAS score > 8 on walking in one or both knees during the 24 hours preceding recruitment Patient with or without receiving regular anti-inflammatory or analgesic drugs, or are not satisfied with drugs being taken and seek a change Willing to come for regular follow up visits.
- •Written Informed Consent from the patient.
排除标准
- •Patients with congenital arthropathy, rheumatoid arthritis, active gout, other type of arthritis with/without inflammation e.g. septic, fibromyalgia or collagen vascular disease Patients with known history of coagulopathies Osteoarthritis of any other joint except knee Patients with history of major trauma or surgery in the knee joint Patients with uncontrolled diabetes and hypertension Body mass index (BMI) >40 kg/m
- •Patients with any severe cardiac, renal and hepatic disease Pregnant and lactating women Patients who participated in any clinical trial within 30 days before enrollment into the study.
结局指标
主要结局
Proportion of subjects requiring analgesics as rescue medication
时间窗: Baseline Visit (Day 0), Visit 1 (Day 30), Visit 2 (Day 60) Visit 3 (Day 90)
Gastrointestinal symptoms due to treatment like stomach pain, heartburn, vomiting, nausea, constipation/ diarrhea etc.
时间窗: Baseline Visit (Day 0), Visit 1 (Day 30), Visit 2 (Day 60) Visit 3 (Day 90)
Improvement in SF-36 Health Survey score
时间窗: Baseline Visit (Day 0), Visit 1 (Day 30), Visit 2 (Day 60) Visit 3 (Day 90)
Symptomatic relief including pain, inflammation, stiffness, swelling, joint flexibility, weight bearing capacity
时间窗: Baseline Visit (Day 0), Visit 1 (Day 30), Visit 2 (Day 60) Visit 3 (Day 90)
Levels of inflammatory mediators CRP and ESR in blood
时间窗: Baseline Visit (Day 0), Visit 1 (Day 30), Visit 2 (Day 60) Visit 3 (Day 90)
Performance of patient on pain VAS scale, WOMAC scale
时间窗: Baseline Visit (Day 0), Visit 1 (Day 30), Visit 2 (Day 60) Visit 3 (Day 90)
次要结局
- Tolerability of study drug by assessing adverse events, serious adverse events during the study period.(Pain status and improvement in symptoms for other than knee pain if any (Shoulder, back ache and muscle spasms))