Efficacy of individualized homoeopathic medicines selected using polarity analysis in reducing the pain of knee osteoarthritis in adults: A double-blind, randomized, placebo-controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Modified Pain Detection (mPDQ) questionnaire
研究概览
简要总结
Osteoarthritis is a heterogeneous group of degenerative joint disease of multifactorial origin characterized by Joint space narrowing, bone spur formation, subchondral bone remodeling, deteriorating integrity and gradual loss of articular cartilage, and synovial inflammation. Knee OA is most common site for osteoarthritis accounting of approximately 20.4% of cases. Though the use of Homeopathic medicine is extensive globally and homeopathic practitioners frequently deal with this condition but efficiency of individualized homoeopathic medicines had shown conflicting results. So we intend to undertake the research to evaluate the efficacy and safety of individualized homeopathic medicines selecting upon using Polarity analysis by Heiner Frei. Thus this double-blind, randomized (2:1), placebo-controlled trial using IHMs based upon Polarity analysis along with concomitant care will be conducted upon 90 patients suffering from Knee OA in both out-patient department and in-patient departments of D. N. De Homoeopathic Medical College & Hospital. Primary outcome measure will be mPDQ , and KOOS, MYMOP-2, frequency of add-on paracetamol and/or NSAIDs (oral/topical), time to resolution of pain of knee will be used as secondary outcome measures. All outcomes will be measured up to 3 months. Group differences will be analyzed statistically. Results will be published in scientific journal.
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 (ICD 11- FA01) as per American College of Rheumatology (ACR) clinical/radiographic classification criteria a.
- •Knee pain b.
- •At least 1 of 3: age more than 50 yrs., stiffness less than 30 min, and crepitus on knee motion.
- •Osteophytes on knee x-ray
- •Patients already undergoing regular oral or topical analgesics or NSAID therapy for painful episodes of OA, provided the medications are stopped completely at least 2 weeks prior study entry.
- •At least 5 polar symptoms and 10 indicated remedies under a rubric.
- •e.g.- primed to expect ‘homoeopathic aggravation’ and available treatment options for the disease conditions, intimated through Patient Information Sheet.
排除标准
- •Not providing with written informed consent of participation.
- •Severe degeneration of knee joint with marked joint narrowing, varus, or valgus deformity of knee (more than 12°), evidenced by imaging or other evidences and requiring surgical intervention.
- •Non-ambulant patients.
- •Self-reported joint disorders other than osteoarthritis (e.g., inflammatory joint disease, specific arthropathy, hyperuricaemia and/or gout, severe axis deviations or instabilities, joint or skin infections, joint prostheses of the lower limbs)
- •Intra-articular injections within 2 weeks before study entry.
- •Transplanted knees.
- •Recent significant knee surgery within last 6 months.
- •Benign tumours and malignant tumours.
- •Patient suffering from active or chronic, systemic or local infection or disease.
- •Patients who are too sick for consultation.
- •Unwilling to take part and not giving consent to join the study
- •Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life.
- •Pregnancy, puerperal women and lactating mother.
- •Tobacco chewing and/or smoking, alcoholism and/or any form(s) of substance abuse and/or dependence (TAPS tool).
- •Self-reported immune-compromised state, AIDS, hepatitis etc.
- •Undergoing homoeopathic treatment for any chronic disease within last 6 months.
- •Simultaneous participation in any other clinical trial.
结局指标
主要结局
Modified Pain Detection (mPDQ) questionnaire
时间窗: Every month up to 3 months
次要结局
- Knee Injury and Osteoarthritis Outcome Score (KOOS)
- Measure Yourself Medical Outcome Profile (MYMOP-2)
- Time to resolution of pain of knee(Every week up to 3 months)
研究者
Dr Tuhina Parveen
D.N. De Homoeopathic Medical College and Hospital