Individualized homoeopathic medicines in pain management of knee osteoarthritis in perimenopausal women with special emphasis on complete symptoms: A double-blind, randomized, placebo-controlled, phase IIb pilot trial

D N De Homeopathic Medical College and Hospital0 个研究点目标入组 60 人开始时间: 待定最近更新: 2023年8月21日

试验速览

暂无简介。

•1. Patients suffering from osteoarthritis of knee joints (ICD -10 code -M 17.9) since last 3 months.
•2. American College of Rheumatology 2019 diagnostic criteria of knee osteoarthritis using history, physical examination and radiographic findings – pain in the 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.
•3. Age between 40 and 55 years
•4. Female patients of perimenopausal age
•5. Patient having complete symptom, i.e., location, sensation, modality and/or concomitant(s).
•6. Literate patients; ability to read English and/or Bengali
•7. Providing written informed consent to participate.

•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. Patients with habits of tobacco chewing and/or smoking, alcoholism and/or any other form (s) of substance abuse and/or dependence.
•12. Self-reported immune-compromised state, and
•13. Already undergoing homeopathic treatment for chronic disease within last 6 months.

发起方

D N De Homeopathic Medical College and Hospital