Clinical study to assess the efficacy & safety of celery extract capsules in the management of knee osteoarthritis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- 1.WOMAC A, B and C subscale scores for pain, stiffness and physical disability.
研究概览
简要总结
OA is a highly prevalent chronic joint disease that leads to significant pain, disability, and loss of function, particularly in the knees. Pharmacological treatments for OA primarily focus on symptom relief and often come with adverse effects, such as gastrointestinal and cardiovascular issues. There is a growing need for safer, more effective treatments that not only alleviate symptoms but also address the underlying pathophysiology of OA.
Celery seed extract has shown potential anti-inflammatory and analgesic properties, making it a promising candidate for OA management. However, there is limited clinical evidence supporting its efficacy and safety in treating knee OA. This pilot study aims to fill this gap by evaluating the effects of celery seed extract capsules on pain, stiffness, and mobility in participants with knee OA over a 90-day period.
The study’s design includes comprehensive assessments of both primary and secondary endpoints. These include changes in WOMAC scores, VAS pain scale, six-minute walk test, inflammatory biomarkers, and reliance on analgesics. Additionally, safety will be rigorously monitored through adverse event profiling and hematological and biochemical evaluations.
The results could offer a new, natural therapeutic option for OA patients, potentially improving their quality of life while minimizing the risks associated with conventional treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adults aged 40 to 65 years (both inclusive), of both sexes, with a Body Mass Index (BMI) not more than 30.00 kg/m²; 2.Confirmed diagnosis of knee osteoarthritis as per clinical ACR (American College of Rheumatology) criteria – Clinical OA of the knee is defined as knee pain and at least three out of six of the following criteria: age more than 50 years old, morning stiffness less than 30 minutes, crepitus on knee motion, bony tenderness, bony enlargement, no palpable warmth; 3.Participants with a minimum pain visual analog scale (VAS) score more than 4 on walking in one or both knees during the 24 hrs.
- •preceding recruitment; 4.Participant ambulant and requiring treatment with an anti inflammatory drug and not receiving regular anti inflammatory or analgesic drugs or not satisfied with drugs being taken and seek a change; 5.Participants taking analgesics ready for the washout period of at least 3 days (or longer depending on the pharmacokinetic of drug) before starting the study intervention; 6.Participants willing to come for regular follow up visits; 7.Participants can walk and give both verbal and written information regarding the study.
排除标准
- •1.Known history of hypersensitivity to herbal extracts or dietary supplements; 2.Pregnant women, lactating women, and women of child bearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy test; 3.Non degenerative joint diseases or other joint degenerative diseases (musculoskeletal disorders) which will interfere with the evaluation of OA (Rheumatoid arthritis, active gout, recent joint trauma (target joint), or joint infection); 4.Participants incapacitated or bound to wheelchair or bed and unable to carry out self-care activities; 5.Treatment with intra-articular injection of corticosteroids into the knee within 3 months preceding study; 6.Ongoing treatment with anticoagulants, hydantoin, lithium, steroids, methotrexate, and colchicine; 7.Evidence of several renal, hepatic, or hematopoietic disease or severe cardiac insufficiency as revealed by laboratory investigations; 8.Participant with congestive heart failure; 9.Ayurvedic formulation or any form of CAM (Complimentary Alternative Medicine) therapy in the preceding 2 months; 10.Administration of intra-articular steroids in the past 3 months or hyaluronic acid in the last 9 months; 11.Indication of surgery for OA knee; 12.Arthroscopy of either knee in the past year; 13.Any condition that in the opinion of the investigator does not justify the participant’s inclusion for the study.
结局指标
主要结局
1.WOMAC A, B and C subscale scores for pain, stiffness and physical disability.
时间窗: 1.At baseline, day 15, day 30, day 60, and day 90. | 2.At day 15, day 30, day 60, and day 90. 3.At baseline, day 15, day 30, day 60, and day 90. | 4.At screening, baseline, day 15, day 30, day 60, and day 90. 5.At baseline and day 90.
•WOMAC-A is assessed by a Likert scale on a range from 0 (none) to 4 (extreme), with higher scores indicating higher levels of pain,
时间窗: 1.At baseline, day 15, day 30, day 60, and day 90. | 2.At day 15, day 30, day 60, and day 90. 3.At baseline, day 15, day 30, day 60, and day 90. | 4.At screening, baseline, day 15, day 30, day 60, and day 90. 5.At baseline and day 90.
•WOMAC- B for levels of stiffness and
时间窗: 1.At baseline, day 15, day 30, day 60, and day 90. | 2.At day 15, day 30, day 60, and day 90. 3.At baseline, day 15, day 30, day 60, and day 90. | 4.At screening, baseline, day 15, day 30, day 60, and day 90. 5.At baseline and day 90.
•WOMAC-C for levels of physical disability
时间窗: 1.At baseline, day 15, day 30, day 60, and day 90. | 2.At day 15, day 30, day 60, and day 90. 3.At baseline, day 15, day 30, day 60, and day 90. | 4.At screening, baseline, day 15, day 30, day 60, and day 90. 5.At baseline and day 90.
2.Physicians Global Assessment for pain.
时间窗: 1.At baseline, day 15, day 30, day 60, and day 90. | 2.At day 15, day 30, day 60, and day 90. 3.At baseline, day 15, day 30, day 60, and day 90. | 4.At screening, baseline, day 15, day 30, day 60, and day 90. 5.At baseline and day 90.
3.Distance covered in six minute walk test.
时间窗: 1.At baseline, day 15, day 30, day 60, and day 90. | 2.At day 15, day 30, day 60, and day 90. 3.At baseline, day 15, day 30, day 60, and day 90. | 4.At screening, baseline, day 15, day 30, day 60, and day 90. 5.At baseline and day 90.
4.VAS pain scale score.
时间窗: 1.At baseline, day 15, day 30, day 60, and day 90. | 2.At day 15, day 30, day 60, and day 90. 3.At baseline, day 15, day 30, day 60, and day 90. | 4.At screening, baseline, day 15, day 30, day 60, and day 90. 5.At baseline and day 90.
5.Radiological examination - X-ray of knee (for participants as per investigators discretion.
时间窗: 1.At baseline, day 15, day 30, day 60, and day 90. | 2.At day 15, day 30, day 60, and day 90. 3.At baseline, day 15, day 30, day 60, and day 90. | 4.At screening, baseline, day 15, day 30, day 60, and day 90. 5.At baseline and day 90.
次要结局
- 1.Biomarkers such as serum PIIANP, Human Procollagen 2 C terminal Peptide, Cartilage Oligomeric Matrix Protein, C Telopeptide of type II collagen (CTX II), TNF Alpha, IL 1, IL 6, IL 7, hsCRP, MMPs (MMP 3) and urinary CTX II.(2.Requirement of analgesic as a rescue medication 3.Changes in gastrointestinal symptoms like heartburn, gastric discomfort, epigastric pain on 4 point Linkert scale 4.KOOS scoring for quality of life. 5.FACIT-F score.)
研究者
Dr Narendra Vaidya
Lokmanya Medical Research Centre and Hospital