A clinical study to evaluate efficacy and safety of Seven Different Topical Formulations in Subjects Suffering from Osteoarthritis of Knee(s)
- Conditions
- Osteoarthritis of Knee
- Registration Number
- CTRI/2012/05/002672
- Lead Sponsor
- Emami Limited
- Brief Summary
On screening visit, a written informed consent will be taken from subjects for their participation in the study. Subject will undergo investigations RA Test, Serum Uric Acid and X-Ray images (Anterioposterior view and Lateral view) of Index/selected knee. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
A wash out period of 3 days will be given. During washout period and the whole study period (viz. 28 days + 3 days), subject will be advised to refrain from NSAID’S or any other local or systemic analgesics except tab Paracetamol (up to 2 gm/day in case of severe joint pain).
On baseline visit (Day 0), subjects will be recruited in the study if he/she meets all the inclusion criteria. Subjects will then undergo general and systemic examinations. Subject’s baseline knee joint(s) pain will be assessed on Visual Analogue Scale (VAS), subjects joint pain subscore, stiffness subscore and physical function subscore will be assessed on WOMAC Index; the knee(s) will be evaluated for soft tissue swelling/synovitis (grade: 0= None, 1= Mild, 2=Moderate, 3=Severe.) All the subjects will be evaluated for their quality of life on SF -36 questionnaires.
After the baseline visit, subjects will be called at
1) R. A. Podar Medical (Ay) college Worli, Mumbai 18,
2) Dept. of Kayachikitsa, PDEA’s College of Ayurveda & Research Center, Sector 25, Pradhikaran, Nigadi, Pune 411044 and
3) Ayurved Research Department, Ayurved Seva Sangh, Ganeshwadi, Panchvati, Nashik – 422003 for 4 follow up visits on 7th day, 14th day, 21st day, and 28th day of the treatment.
At baseline visit and at every follow up visit except the last follow up visit. As per computer generated randomization list each subject will be provided either investigational product or comparator product to be used for 7 days duration. Additional medicine of 2 days will also be provided in case if follow up is delayed, maximum upto 2 days. Patients will be advised to apply sufficient quantity of given product on the affected knee(s) joint and massage gently twice daily for 4 weeks.
On every follow up visit, subjects will undergo general and systemic examinations. The Knee joint(s) pain will be assessed on Visual Analogue Scale (VAS); subject’s knee joint(s) pain subscore, stiffness subscore and physical function subscore will be assessed by WOMAC Index; the knee(s) will be evaluated for soft tissue swelling/synovitis. Patient’s global evaluation and Investigator’s global evaluation for overall improvement will be done on every follow up visit. On every follow up visit, all the subjects will be evaluated for their quality of life on SF -36 questionnaires. Also cooling, counter irritation and warmness effects will be evaluated at each follow up visit. Tolerability of the trial medicine will be assessed by the investigator and the subject at the end of the 28 days of the treatment. Drug compliance will also be assessed by the investigator on every visit starting from first follow up visit till the completion of the trial. All the subjects will closely be monitored for any possible adverse events/ adverse drug reactions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 210
•Symptoms of osteoarthritis in one or both knee joints for a minimum of six months and maximum for five years • History of knee pain due to osteoarthritis requiring the use of NSAIDs, Acetaminophen, or another analgesic agent on a regular basis (greater than or equal to three days per week) for at least six months before the screening visit •OA confirmed by radiographs and diagnosed according to ACR diagnostic Criteria (clinical and radiological) for the osteoarthritis of the knee(s) •Subjects may take tab paracetamol (Less than of equal to 2g per day) for breakthrough pain •Subjects not having knee joint deformity •Subjects signing written informed consent and ready to comply with the protocol requirements •Subjects with pain VAS reater than 40 mm on weight bearing activities.
- •Rheumatoid arthritis, gout, pseudo gout, inflammatory arthritis, Pagets disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease •History of surgery, including arthroscopy, or major trauma to the study joint in the previous six months before the screening visit •Subjects requiring knee arthroplasty within 6 months of screening or anticipating any need for a surgical procedure on the index joint during the study •Signs of clinically important active inflammation of the study knee joint including redness, warmth and/or a large, bulging effusion with the loss of normal contour at the screening and/or baseline visits •Use of any analgesics except the study medication or paracetamol; •Use of systemic corticosteroids within 2 months of screening, or intra-articular viscosupplementation within the past 3 months •Use of any other investigational drug within 1 month prior to randomization; •Subjects having diabetes mellitus, tuberculosis, HIV, Ischemic Heart Disease •Known other major medical or surgical disease; •Pregnancy & Lactation.
- •Known hypersensitivity to ingredients used in study drug.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1). Knee Joint Pain on VAS 28 days 2). WOMAC Index 28 days
- Secondary Outcome Measures
Name Time Method 1). Quality of life on SF -36 questionnaire 2). Global assessment for overall improvement by the subject himself/herself at the end of 28 days of study treatment.
Trial Locations
- Locations (3)
Ayurved Research Department, Ayurved Seva Sanghs Ayurved Mahavidyalaya,, Ganeshwadi, Nashik
🇮🇳Nashik, MAHARASHTRA, India
Department of Kayachikitsa, PDEA’s College of Ayurveda & Research Center, Nigadi, Pune
🇮🇳Pune, MAHARASHTRA, India
Department of Kayachikitsa, R.A. Podar Medical (Ay) College and M.A. Podar Hospital, Worli, Mumbai
🇮🇳Mumbai, MAHARASHTRA, India
Ayurved Research Department, Ayurved Seva Sanghs Ayurved Mahavidyalaya,, Ganeshwadi, Nashik🇮🇳Nashik, MAHARASHTRA, IndiaDr Shishir P PandePrincipal investigator9420830818shishir.nsk@gmail.com