Health Condition 1: null- Osteoarthritis of Knee
Conditions
Interventions
Intervention1: Boswellia extract (Aflapin): Two 50 mg capsules per day for 30 days
Control Intervention1: Placebo: 2 capsules per day for 30 days
Sponsors
Laila Nutraceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Onset of actionTimepoint: Baseline day 5 and day 30 | — |
Countries
India
Contacts
Public ContactAlluri V Krishna Raju
Laila RnD Centre
Outcome results
None listed