Multicentric, randomized, double-blind, parallel-group, controlled trial to evaluate efficacy and safety of gel containing Plumbago zeylanica root for mild to moderate osteoarthritis of knee
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 入组人数
- 292
- 试验地点
- 3
- 主要终点
- Changes in WOMAC score- Pain, WOMAC score- Stiffness, WOMAC- Functional Total
研究概览
简要总结
Patients visiting the orthopedic OPD of 3 selected hospitals, aged 40-70 years with clinically diagnosed and radiologically confirmed mild to moderate (KL grade II & III) symptomatic cases of osteoarthritis of knee joints will be subjected to detailed screening. Consecutive patients fulfilling the inclusion/exclusion criteria will be enrolled for the study after obtaining written informed consent, and randomly assigned to one of two groups in a 1:1 ratio using computer-generated random sequences. The intervention group will receive topical application of 70% P. zeylanica root gel twice daily for 4 weeks whereas, the control group will have topical application of diclofenac 1% gel twice daily for 4 weeks. Participants will be followed up weekly at week 1 (± 2 days), 2 (± 2 days), 3 (± 2 days), and 4 (± 2 days) and evaluated for WOMAC score, pain assessment by VAS score, measurement of range of motion using gonioscopy, drug compliance, need for rescue medicine, adverse reaction. Quality of life assessment will be done using Osteoarthritis Knee and Hip Quality of Life (OAKHQOL) assessment at baseline, week 4 and week 12.
Hypothesis - The test drug (gel containing Plumbago zeylanica L. root) improves the OA condition, in terms of WOMAC and pain scores and the quality of life in OA patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator 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
- •Male and female patients with age between 40-70 years
- •Clinically diagnosed and radiologically confirmed mild to moderate (KL grade II & III) symptomatic cases of OA of knee joints
- •Onset of symptom duration greater than or equal to 6 months at the time of screening
- •A score of greater than or equal to 9 on the 20-point Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale at baseline
- •Greater than or equal to 5 score on 10-point visual analogue scale (VAS) for pain at baseline 6.
排除标准
- •Patients having severe (KL grade IV) and disabling arthritis in targeted or contralateral knee joint
- •Patients with radiologically abnormal knee alignment
- •Those who are suffering from skin related problem at local sites of drug application which may affect drug application
- •Patients with history of HIV, Peripheral vascular diseases
- •Those who are on treatment with immuno-suppressive drugs and biologicals
- •Patients with history of Chikungunya, Dengue, or other viral infections in the past six months
- •Pregnant and lactating women
- •Any condition which in the opinion of investigator will place the subject at risk or will influence the conduct of study or interpretation of results
- •Diagnosed cases of Rheumatoid arthritis (RA factor positive) and Gouty arthritis (Serum Uric acid greater than UNL)
- •Patient requiring any systemic analgesic for other conditions which can affect the outcome of study drug
- •Patient on systemic corticosteroid therapy
- •Known case of history of allergy with NSAIDs or test drug
- •Patients with BMI greater than or equal to 35 kg/m2.
结局指标
主要结局
Changes in WOMAC score- Pain, WOMAC score- Stiffness, WOMAC- Functional Total
时间窗: Baseline/Screening | Week 1 | Week 2 | Week 3 | Week 4 | Week 6 (post intervention) | Week 8 (post intervention) | Week 12 (post intervention)
次要结局
- Changes in range of motion (goniometry)(Baseline/Screening)
- Changes in Quality of life at the end of intervention and at the end of post intervention as compared to baseline using Osteoarthritis Knee and Hip Quality of Life (OAKHQoL) questionnaire(Baseline)
- To determine extent of use of rescue medicines in the both the group during the study(Week 1)
研究者
Dr Harsha Hegde
ICMR National Institute of Traditional Medicine Belagavi