跳至主要内容
临床试验/CTRI/2024/08/071761
CTRI/2024/08/071761尚未招募2/3 期

Efficacy of Panchatikta Ghruta Guggulu in the Management of Osteoarthritis in Postmenopausal Women -A Randomized controlled Trial

KLE Ayurveda Hospital and Medical Research Centre1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2024年8月30日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
104
试验地点
1
主要终点
Changes in Janu sandhi shoola (Knee osteoarthritic pain) i.e WOMAC28 (Western Ontario and Mc-Master University Osteoarthritis Index) and VAS29 Scale

研究概览

简要总结

Osteoarthritis is chronic degenerative disorder of multifactorial etiology characterized by the loss of articular cartilage. Menopause has a multitude of effects that affect knee OA, including hormonal shifts, loss of bone mineral density, muscle loss and tendon strength and this common musculoskeletal condition particularly afflicts women in menopause. India is expected to be the chronic disease capital with 60 million people with arthritis by 2025, and prevalence is about 22% to 39%, globally affecting 18% 0f woman over the age of 60.It appears that osteoarthritis in men and women may have different pathogenesis mechanism. Experimental and clinical studies strongly support a link between the increased state of proinflammatory cytokine activity and postmenopausal bone lossThere are studies showing that postmenopausal women have elevated serum levels of proinflammatory cytokines, especially IL-6 and TNF-α.alliative management for Knee Osteoarthritis include NSAIDs and Opioids as mainstays of pharmacotherapy, even Knee Replacement is another option in managing Osteoarthritis. Etoricoxib  seem to be the most effective oral NSAIDs for pain and function in patients with osteoarthritis.But still there are some limitations with adverse effects furthermore; there are no proven disease-modifying therapies for osteoarthritis. Thus, Preventive measures previously addressed need to be reaffirmed throughout the world so that we will effectively reduce the future burden and disability of OAWith this background here is an attempt made to find out the role of ayurveda formulation in management of  osteoarthritis in postmenopausal woman. So the herbomineral compound Panchatikta gruta Gugguluformulation explained in the classics for the treatment of sandhigata vata (osteoarthritis) has been selected for the present study.Hence, the current research has been planned to evaluate the efficacy of Panchatikta Ghruta Guggulu  in the management of osteoarthritis in post menopausal woman through assessing changes in pain, inflammation,  joint mobility, bone metabolism and  quality of life

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 60.00 Year(s)(—)
性别
Female

入选标准

  • 1.Subjects aged between
  • 60 years. 2.Patients with classical presentations of Sandhigata vata and rajonivrutta stri will be selected irrespective of their religion and occupation. 3.Subjects fulfilling the diagnostic criteria & diagnosed previously (As per American college of Rheumatology (ACR) classification criteria for OA of the Knee). 4.Affected knee joint.
  • Single or Both 5.Subject who submit a written informed consent. 6.One month after the completion of participation in any other clinical trial.

排除标准

  • 1.Severe arthritis1.(KL grade IV) 2.Patients with RA, Gout, Osteoporosis and other musculoskeletal system disorders 3.Known cases of secondary OA due to tuberculosis (TB), syphilis, aids and leprosy 4.Gross disability like bedridden and confined to wheel chair 5.Patients with other major systematic disorders which interfere with the treatment will be excluded like uncontrolled DM 6.Patients with .Significant knee injury within past 6 months; presence of a rash or open 6.wound over the knee.
  • 7.Use of NSAID’s, Analgesics, Intra articular steroid injections within the past period of 30 days 8.Patients with history of knee surgery or arthroscopy within the past year; knee replacement on study knee 9.Any other conditions which in the opinion of investigator will place the subject at risk or will influence the conduct of study or interpretation of results.

结局指标

主要结局

Changes in Janu sandhi shoola (Knee osteoarthritic pain) i.e WOMAC28 (Western Ontario and Mc-Master University Osteoarthritis Index) and VAS29 Scale

时间窗: baseline and at 30th ,60th days

次要结局

  • –Changes on walking speed(–Changes in Serum Calcium & alkaline phosphatase)

研究者

发起方
KLE Ayurveda Hospital and Medical Research Centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Uma Shetti

KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi

研究点 (1)

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