Analytical characterization of Harpagophytum procumbens mother tincture and its effectiveness in comparison with individualized homoeopathic medicine in the management of knee osteoarthritis: An open- label randomized controlled trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
研究概览
简要总结
Osteoarthritis (OA) is recognized as a complex condition involving changes in the underlying bone, chronic inflammation of the synovium, immune responses, and even neuroinflammation that contribute to pain and joint damage. This study aims to fill the existing research gap and contribute to the evidence base for Homoeopathic management of knee osteoarthritis Therefore, randomized controlled trial will be conducted at the OPD of NIH, Delhi to compare the effectiveness of individualized homoeopathic treatment with Harpagophytum procumbens in patients with knee osteoarthritis. Analytical characterization of Harphagophytum procumbens will be done followed by clinical study. Through randomisation two groups will be allotted, in which Group A, Harpagophytum procumbens mother tincture will be administered 20 drops twice per day for 3 months which is safe as per the published literature and in Group B, Individualised Homoeopathic medicine will be prescribed according to homoeopathic principle. All participants will be followed up at 2-week intervals for a minimum of 12 weeks. Outcome will be assessed at baseline and after 3 months of intervention. All the cases will be analyzed with WOMAC Index Score and Knee X-Ray after 3 months of intervention. At each visit, clinical progress will be documented, and adverse events (if any) or complications will be noted, and measure will be taken accordingly. Lastly MONARCH score will be evaluated at the end of treatment.
Duration of therapy will be of 3 months.
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
- 35.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •All religion and all socio-economic status
- •Diagnosis will be done by using American College of Rheumatology (ACR) criteria including Knee X-Ray
- •Grade I and II knee osteoarthritis as per Kellgren–Lawrence Grading Scale.
- •Participant who are willing to give written informed consent.
排除标准
- •Advanced and complicated cases of osteoarthritis requiring surgical intervention.
- •Participants with other complicated joint disorder (seronegative arthropathies, RA, Gout etc.) which interfere with the evaluation of OA.
- •Adults who had a history of heart attack or stroke, or other atherosclerotic disease.
- •Uncontrolled systemic diseases like HTN, DM, Hypothyroidism etc.
- •Pregnant and lactating women
- •Psychologically ill patients
- •Immunocompromised patients
- •Participants undergoing homoeopathic treatment for any other chronic disease for last 6 months.
- •Simultaneous participation in any other clinical trial.
研究者
Dr HARSHITA PAHWA
NATIONAL INSTITUTE OF HOMOEOPATHY
