A clinical trial to study the efficacy of Aflapin, an ayurvedic agent in patients with osteoarthritis of knee.
- Conditions
- Health Condition 1: null- Osteoarthritis of Knee
- Registration Number
- CTRI/2011/07/001912
- Lead Sponsor
- aila Nutraceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
The subject is in the age range of 40 to 70 years
The subject can understand risks and benefits of the protocol
The subject has voluntarily given written informed consent to participate in this study
Willingnes to participate in 3 clinic visits and availability for the duration of the study 1 month
The subject is of normal health as determined by medical history and physical examination of the subjects performed within 7 days prior to the commencement of the study
Ability to walk
Radiographic evidence (X ray diagnosis) of OA during screening
Unilateral or bilateral OA of the knee for more than 3 months (ACR criteria)
VAS score during most painful knee movement between 40 to 70 after 5 day withdrawal of usual medicine
Lequesnes functional index score greater than 7 points after 5 day withdrawal of usual medicine
If female and:
Negative result in urine pregnancy test
Of childbearing potential is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s) such as condoms foams jellies diaphragm intrauterine device (IUD) or abstinence or
Is postmenopausal for at least 1 year or
Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy hysterectomy)
Underlying inflammatory arthropathy or RA positive to Systemic Lupus Erythematosis (SLE)
Hyperuricemia greater than 440 uM and or past history of gout
Expectation of surgery in the next 4 months
Recent injury in the area of affected by OA of the knee (past 4 months)
Severe OA VAS score greater than 70
Intra-articular corticosteroid injections within the last 3 months
Hypersensitive to NSAIDs
Abnormal Liver of Kidney function tests
Major abnormal findings on complete blood count
History of peptic ulceration and GI haemorrhage
Uncontrolled hypertension
History of congestive heart failure
Hyperkalemia
Hypersensitivity or allergy to spices and herbs
History of cancer as well as gastrointestinal renal hepatic cardiovascular haematological or neurological disorders
High alcohol intake more 2 standard drinks per day
Female subjects who are currently pregnant breastfeeding
History of psychiatric disorder that may impair the ability of subjects to provide written informed consent
Investigations with blood samples of the subject shows presence of disease markers of HIV 1 or 2 Hepatitis B or C viruses or syphilis infection
Use of other natural health products including glucosamine and chondroitin other than multi vitamins one month prior to study and during the study
Use of concomitant prohibited medications other than rescue medication
BMI less than 18 or greater than 30
Clinically abnormal ECG
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of Aflapin® in pain management and alleviating symptoms of OA using pain scores and orthopaedic examination and biomarkersTimepoint: Baseline Day 5 Day 30
- Secondary Outcome Measures
Name Time Method Onset of actionTimepoint: Baseline day 5 and day 30