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Homeopathic treatment of knee osteoarthritis

Phase 3
Completed
Conditions
Health Condition 1: null- Knee osteoarthritisHealth Condition 2: M179- Osteoarthritis of knee, unspecified
Registration Number
CTRI/2018/04/013395
Lead Sponsor
ational Institute of Homoeopathy Ministry of AYUSH Govt of India
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
128
Inclusion Criteria

1. Age 40-70 years

2. Both sexes

3. Diagnosed knee osteoarthritis as per American College of Rheumatology (ACR) clinical or radiographic classification criteria (sensitivity 91%; specificity 86%):

a) Knee pain

b) At least 1 of 3: age more than 50 yrs, stiffness less than 30 min, and crepitus on knee motion

c) Osteophytes on x-ray knee (AP/lateral view)

4. Patients already undergoing regular oral or topical analgesics or NSAID therapy for painful episodes of osteoarthritis, provided the medications are stopped completely at least 2 weeks prior study entry

5. Providing written informed consent

6. Literate patients; ability to read English and/or Bengali

Exclusion Criteria

1. Severe degeneration of knee joint with marked joint narrowing, varus, or valgus deformity of knee ( >12°), evidenced by imaging or other evidences and requiring surgical intervention

2. Non-ambulant patients

3. Self-reported joint disorders other than osteoarthritis (e.g., inflammatory joint disease, specific arthropathy, severe axis deviations or instabilities, joint or skin infections, joint prostheses of the lower limbs)

4. Intra-articular injections within 2 wk before study entry

5. Transplanted knees

6. Recent significant knee surgery within last 6 months

7. Patients who are too sick for consultation

8. Unwilling to take part and not giving consent to join the study

9. Unable to read patient information sheet

10. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life

11. Pregnancy and lactation

12. Substance abuse and/or dependence

13. Self-reported immune-compromised state, and

14. Undergoing homeopathic treatment for any chronic disease within last 6 months

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Bengali version of the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaireTimepoint: At baseline, after 3 months, and after 6 months
Secondary Outcome Measures
NameTimeMethod
Five individual KOOS subscale scores â?? pain, other symptoms, activity of daily living (ADL), sport or recreation, and knee-related quality of life (QOL)Timepoint: At baseline, after 3 months, and after 6 months;Frequency of add-on Paracetamol and/or NSAIDs (oral/topical) useTimepoint: 6 months
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