EFFICACY OF INDIVIDUALIZED HOMOEOPATHIC MEDICINES IN 50-MILLESIMAL POTENCY IN PERI AND POST MENOPAUSAL WOMEN SUFFERING FROM OSTEOARTHRITIS OF KNEE WITH ITS MIASMATIC ANALYSIS: A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 167
- 试验地点
- 1
研究概览
简要总结
Osteoarthritis (OA) is a prevalent, progressively developing joint disorder that notably affects middle-aged and older individuals, substantially impacting their quality of life and ability to perform daily activities. Postmenopausal women are considered a high-risk group for OA due to physiological changes associated with menopause, including hormonal fluctuations, as well as other factors such as age-related joint degeneration and heightened pain sensitivity. This 3-months, double-blind, randomized (2:1), placebo-controlled trial of individualized homoeopathic medicines against placebos will be carried out at The Calcutta Homoeopathic Medical College & Hospital on 167 participants with Osteoarthritis(OA) of knee joint. Primary outcome is Knee injury and osteoarthritis outcome score (KOOS); secondary outcome is EQ-5D-5L questionnaire ; all to be measured at baseline, and every month, up to 3 months. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals.
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
- 40.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Female patients of peri and post-menopausal age suffering from osteoarthritis of knee joints (ICD-11 FA01.0 for primary, FA01.1 for post-traumatic, and FA01.2 for other secondary type) since last 3 months.
- •2.American College of Rheumatology 2019 diagnostic criteria of knee osteoarthritis using history, physical examination and radiographic findings pain in knee and one of the following-(a) age over 50 years, (b) morning stiffness less than 30 min, and (c) crepitus on active motion and osteophytes on x-ray.
排除标准
- •1.Severe degeneration of knee joint with mark joint narrowing, varus, or valgus deformity of knee; as evidenced by imaging or other evidences and requiring surgical intervention. 2.Self-reported joint disorders other than osteoarthritis (e.g., inflammatory joint disease, specific arthropathy, hyperuricemia and/or gout, severe axis deviations or instabilities, joint or skin infections, joint prostheses of the lower limbs). 3.Intra-articular injections within 2 weeks before study entry. 4.Transplanted knees. 5.Non ambulant patient. 6.Obese patient (body mass index 30.0 or more). 7.Recent significant knee surgery within last 6 months. 8.Vulnerable population.
- •unconscious, ambulatory, too seek for consultation, differently abled, terminally or critically ill patients, mentally incompetent people. 9.Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure. 10.Pregnant and puerperal women, lactating mothers. 11.Severe osteoporosis and already diagnosed case of osteoarthritis of knee joint.
研究者
Dr Ishrat Parween
The Calcutta Homoeopathic Medical College and Hospital