CTRI/2025/02/080777进行中（未招募）不适用
A Randomized, double-blind, placebo-controlled study to evaluate the efficacy of herbal formulation in subjects with mild Osteoarthritis.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change from baseline to the end of the study period in
研究概览
简要总结
The purpose of the study is to evaluate the efficacy of LI51202F1 in subjects with mild osteoarthritis and the subjects will be adminstered with either test or placebo orally for 30 days after breakfast.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy male and female subjects aged between 40-70 years with body mass index (BMI) of 18.
- •29.9 kg/m
- •Subjects with Knee osteoarthritis grade II of Kellgren and Lawrence assessed based on X-ray.
- •One knee joint (or most painful knee joint among the two) with a VAS score of 40-70 mm.
- •Subjects with sedentary lifestyle, no regular athletic or sports activities.
- •Subject agrees to maintain diet tracker.
- •Results of screening should be within normal range or considered not clinically significant by the Principal Investigator.
- •Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera, or double-barrier and have a negative pregnancy test at the screening visit.
- •Ability to understand the risks/benefits of the protocol and willing to sign the written informed consent.
- •Subject agrees to avoid use of dietary supplements containing proteoglycans, hyaluronic acid, N-acetyl glucosamine, glucosamine, chondroitin sulfate, collagen peptides, Curcumin, Boswellia or any other constituents of the test supplement for the duration of the study.
- •Subject agrees to avoid use of medications for pain, including NSAIDS and any other oral or topical pain relief product with the exception of the rescue medication provided by the study site.
排除标准
- •Routine use of dietary supplements containing proteoglycans, hyaluronic acid, N-acetyl glucosamine, glucosamine, chondroitin sulfate, collagen peptides, Curcumin, Boswellia or any other constituents of the test supplement within 3 months prior to enrolment.
- •Subjects with any possible signs/ indications/ history of severe arthritis, joint disorders including dislocations and quadriceps tendons tear.
- •History of underlying inflammatory arthropathy or Gout or severe RA or OA.
- •Clinical history of bone or cartilage disorders including fracture and distortion within one year prior to enrolment.
- •Have taken any Intra-articular or Oral corticosteroids, glucosamine + chondroitin, within 3 months prior to screening visit (Visit 1) or intra-articular treatment/injections with hyaluronic acid within 6 months preceding the treatment period.
- •Subjects with a history of knee or hip joint replacement surgery, or any hip or back pain which interferes with ambulation.
- •Expectation of surgery during the study duration period.
- •Fasting blood glucose level greater than 125 mg/dl.
- •Female subjects, who are pregnant, breast feeding or planning to become pregnant.
- •Subject having known allergy or suspected hypersensitivity or sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or investigational product or any other herbal products.
- •Have taken acetaminophen/ paracetamol, ibuprofen, aspirin or other NSAIDS or any other pain reliever (OTC or prescription) or any natural health product, (excluding vitamins), within 7 days prior to the screening visit (Visit 1).
- •Subjects having used any immunosuppressive drugs in the last 6 months (including steroids or biologics) and those with history of immune system and autoimmune disorders.
- •Subjects who have any physical disability which could interfere with their ability to perform the functional performance measures included in this protocol.
- •Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •History of congestive heart failure or any vascular conditions.
- •Subjects with HIV Positive status.
- •Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies, hypothyroidism.
- •Subjects consuming alcohol (less than 2 drinks per week) and smoking greater than 5 cigarettes per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.).
- •Any other condition that, in the opinion of the investigator, would adversely affect the subject’s ability to complete the study or its measures.
- •Subjects who have participated or currently participating in another clinical trial within 30 days prior to screening.
结局指标
主要结局
Change from baseline to the end of the study period in
时间窗: Day 1 Baseline,Day 5,Day 15 and Day 30
WOMAC (pain)
时间窗: Day 1 Baseline,Day 5,Day 15 and Day 30
次要结局
- Change from baseline to the end of the study period in Visual Analogue Scale (VAS)(Day 1 Baseline, Day 5,Day 15 and Day 30)
- Change from baseline to the end of the study period in WOMAC (stiffness, physical function and Total score)(Day 1 Baseline, Day 5,Day 15 and Day 30)
- Change from baseline to the end of the study period in 30 sec Chair Stand Test (CST)(Day 1 Baseline, Day 5,Day 15 and Day 30)
- Change from baseline to the end of the study period in 6-minute walk test (SMWT)(Day 1 Baseline, Day 5,Day 15 and Day 30)
- Change from baseline to the end of the study period in Stair climb test (SCT)(Day 1 Baseline, Day 5,Day 15 and Day 30)
- Change from baseline to the end of the study period in Knee flexion/extension range of motion(Day 1 Baseline, Day 5,Day 15 and Day 30)
- Change from baseline to the end of the study period in Physician Global Assessment (PGA) and Subjective Global Assessment (SGA)(Day 5,Day 15 and Day 30)
- Change from baseline to the end of the study period in serum biomarkers hs CRP and TNF alpha(Day 1 Baseline and Day 30)
研究者
Dr Anand Kumar Upadhyay
Rambilas Panacea Hospital
研究点 (1)
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