Homeopathic treatment of knee osteoarthritis

Phase 3

Completed

Conditions: Osteoarthritis of knee, unspecified,

Registration Number: CTRI/2018/04/013395

Lead Sponsor: National Institute of Homoeopathy Ministry of AYUSH Govt of India

Brief Summary: Osteoarthritis (OA) is a heterogeÂneous group ofdegenerative joint disease of multi-factorial origin, characterized bydefective integrity and progressive loss of articular carÂtilage, sub-chondralbone remodelÂling, joint space narrowing and bone spur formation, as well assynovial inflammation. Pain and functional impairment are the keydomains of the burden of suffering experienced by people with OA that is ofprimary concern, and that burden can be sigÂnificant, and taken together theyofÂten exert a significant reduction in quality of life. Since the last decade, recommendations formanaging OA have focused persistently on relievÂing pain and stiffness andimproving physical function as important goals of therapy. However, conventional drug therapy for OAsuccessfully reÂlieves pain only, alongside producing adverse gastrointestinaland carÂdiovascular effects, especially with long-term use. Although clinical guidelines recommendparacetamol as first line analgesic drug for knee osteoarthritis, high qualityevidence (meta-analysis of RCTs comparing the efficacy and safety ofparacetamol with placebo) suggest Paracetamol as ineffective in the saidcondition, provides minimal short term benefit, but nearly four times morelikely to have abnormal results on liver function tests compared to placebo. Nonpharmacologic modalities strongly recommendedfor the management of knee OA were aerobic, aquatic, and/or resistanceexercises as well as weight loss for overweight patients. Thus controversies regarding efficacy of themainstay pharmacological agent and inadequacy of outcomes, people frequentlyrefer to CAM therapies and homeopathy. However, effectiveness of homeopathictreatment strategies, especially classic/individualized and specific mothertinctures has remained under-researched. A systematic review of clinical trials of osteoarthritis identified8 controlled trials published during 1980-2013 using â€˜complex homoeopathyâ€™ and â€˜combinationformulaeâ€™. Overall results of the review showed homoeopathic complexes having aclear advantage in the treatment of osteoarthritis; however, the eviÂdence was notconvincing enough to arrive at a definite conclusion because of methodologicalinconsistencies and insufficient trial reporting. Though mother tinctures are frequently used as adjunctive to treat OA in homeopathy, their effectiveness has not been explored till date. In this prospective, open, randomized, two parallel arms,pragmatic, clinical trial, 128 patients suffering from diagnosed OA knee will be randomized to either individualized homeopathy plus mother tincture arm (verum; IH + MT; n=64) or individualized homeopathy alone (control; IH; n=64). Outcomes will be measured in terms of Knee injury and Osteoarthritis Outcome Score(KOOS), and five individual KOOS subscale scores â€“ pain, othersymptoms, ADL, sport/recreation, and QOL, measured at baseline, after 3 months and 6 months, and frequency of add-on Paracetamol and/or NSAIDs (oral/topical)during study period of 6 months. Comparative analysis will be carried out in the end to detect group differences, if any. Results will be published in scientific journals.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 128

Inclusion Criteria

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

Severe degeneration of knee joint with marked joint narrowing, varus, or valgus deformity of knee (>12Â°), 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.
Undergoing homeopathic treatment for any chronic disease within last 6 months.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bengali version of the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire	At baseline, after 3 months, and after 6 months

Secondary Outcome Measures

Name	Time	Method
Five individual KOOS subscale scores â€“ pain, other symptoms, activity of daily living (ADL), sport or recreation, and knee-related quality of life (QOL)	At baseline, after 3 months, and after 6 months
Frequency of add-on Paracetamol and/or NSAIDs (oral/topical) use	6 months

Trial Locations

Locations (1): National Institute of Homoeopathy, Govt. of India
🇮🇳
Kolkata, WEST BENGAL, India
National Institute of Homoeopathy, Govt. of India
🇮🇳Kolkata, WEST BENGAL, India
Abhijit Chattopadhyay
Principal investigator
7003547446
drac.nih@gmail.com