Comparing the effects of two succussion against ten of pre-defined homoeopathic medicines in managing pain of knee osteoarthritis in adult: A double-blind, randomized, controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Knee injury Osteoarthritis outcome score- 12 (KOOS-12) Questionnaire
研究概览
简要总结
Osteoarthritis affected about 528 million people globally in 2019, an
increase of 113% from 1990. About 73% of people with osteoarthritis are
over 55, and 60% of them are female[1]. With a frequency of 365 million,
the knee is the most often impacted joint, followed by the hip and the
hand[1] . Being primarily related to ageing, the prevalence of OA will
steadily increase and is expected to be the single greatest cause of
disability in the general population by 2030[2]. . Under such
circumstances, we intend to undertake this research project. . A double
blind, randomized (1:1), trial will be conducted on 100 adults with Knee
OA at the OPD of D. N. De Homoepathic medical College and hospital.
To find the difference between two succussion and ten succussion of
homoeopathic medicine of centesimal potency. It has a evidence that
centesimal potency of homoeopathic medicine produce better result in
some previous study[3]. Assessment will be done by evaluating the, Knee
injury and osteoarthritis outcome score-12 (KOOS-12) [primary
outcome], Measure Yourself Medical Outcome Profile version2.0
(MYMOP-2) [secondary outcome] every month upto 3 months.
Comparative analysis will be carried out to detect group differences.
Introduction 595 million people around the world suffer from degenerative arthritis in
their knees, which accounts for 7.6 % of the global population. This
degenerative disease is caused by a breakdown of the cartilage in knee
joint, resulting in pain, stiffness and decreased mobility. Conventional
treatments for this condition include pain medication, physical therapy
and, in extreme cases, surgery, but these do not always provide lasting
relief and may carry potential side effects. While there is demand for
homeopathy in the management of knee pain of knee osteoarthritis but
the available evidences suggested no definitive results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age 50-70 years 2.Participants of either sex or transgender.
- •3.Diagnosed knee OA as per American College of Rheumatology clinical or radiographic classification criteria a.Knee pain b.Age above 50 c.Stiffness lasting less than 30 minutes d.Crepitus during knee motion 4.Participants who are familiar with the treatment or have past experience with it.
- •For example being prepared for "homoeopathic aggravation" and being informed of the available treatment choices for the illness conditions through the Patient Information Sheet 5.Physicians of d.n.de.homoeopatic medical college and hospital outpatient (OPD) they will prescribe individualised homoeopathic medicine in cases of osteoarthritis knee pain considering the totality of symptom and miasmatic analysis.
- •If the selected medicine is in the pre-defined project medicine list then only patient will be enrolled.
排除标准
- •1.Not providing with written informed consent of participation.
- •2.severe knee joint deterioration.
- •3.Non-ambulant patients.
- •4.Intra-articular injections within 2 weeks before study entry.
- •5.Transplanted knees.
- •6.Other than osteoarthritis, self-reported joint conditions include inflammatory joint illness, particular arthropathy, gout and or hyperuricaemia significant axis deviations or instabilities joint or skin infections and lower limb joint prosthesis.
- •7.Recent significant knee surgery within last 6 months.
- •8.Benign tumours and malignant tumours.
- •9.Patient suffering from active or chronic, systemic or local infection or disease.
- •10.Patients who are too sick for consultation.
- •11.Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life.
- •12.Pregnancy, puerperal women and lactating mother.
- •13.Self-reported immune-compromised state, AIDS, hepatitis etc.
- •15.Alcoholism, tobacco chewing, smoking, and or substance abuse and or dependence in any form (TAPS tool) 16.Simultaneous participation in any other clinical trial.
结局指标
主要结局
Knee injury Osteoarthritis outcome score- 12 (KOOS-12) Questionnaire
时间窗: Knee injury Osteoarthritis outcome score- 12 (KOOS-12) Questionnaire
次要结局
- Measure Yourself Medical Outcome Profile Version 2 (MYMOP-2)(At Baseline, monthly, up to 3 months)
研究者
JAGANNATH DAS
D. N. De Homoeopathic Medical College and Hospital