A Clinical Study to Evaluate the Safety and Efficacy of CurQlife 500 mg and CurQlife P 500 mg (Curcumin based formulation) in Reducing Symptoms of Knee Osteoarthritis.

Completed

Conditions: Unilateral or bilateral OA of the knee for greater than 3 months (ACR criteria)

Registration Number: CTRI/2013/12/004266

Lead Sponsor: Laila Pharmaceuticals Pvt Ltd

Brief Summary: The proposed study is to assessthe Efficacy and safety of novel formulation of curcumin I, curcumin II and IIIin Reducing Symptoms of Knee Osteoarthritis by decreasing joint pain andimprovement in joint function.

Several osteoarthritis trialshave been conducted to evaluate the safety and efficacy of curcumin inalleviating the symptoms of pain and inflammation associated withosteoarthritis and is demonstrated to be both safe and effective for long-termuse.

A total of 60 ambulatory male andfemale subjects with 40-75 years of age with a Body Mass Index (BMI) ofapproximately 18 to 30 kg/m2,having Unilateral or bilateral OA of the knee forgreater than 3 months (ACR criteria)will be screened and randomly assigned intoany of the three treatment arms in 1:1:1 ratio (CurQlife 500 mg, CurQlife P 500mg and Placebo).

Allsubjects randomized to Active group will be advised to take one capsule twice dailyThere will be a total of five visits in the study [ScreeningVisit/Randomization visit (Day -7 to Day 0) Visit 1 and Study Periods [Day 7,Day 15, Day 30,and Final visit [Day 60].

The study assessment is throughChange in WOMAC,VAS,LFI and Knee flexion from baseline to day 60.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

1.Ambulatory, Male and female subjects 40 â€“ 75 years of age with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2.
2.Unilateral or bilateral OA of the knee for greater than 3 months (ACR criteria) 3.Subjects with radio graphic evidence by Kellgren-Lawrence grade 2 to grade 3 4.Female subjects of childbearing potential must be using a medically acceptable form of birth control.
Female subjects of non childbearing potential must be amenorrheic for at least 1 years or had a hysterectomy and/or bilateral oophorectomy 5.VAS score during the most painful knee movement between 40-70 mm 6.Subjects having mild-to-moderate pain not adequately or completely controlled with anti-inflammatory drugs 7.Results of screening are within normal range or considered not clinically significant by the Principal Investigator 8.Be willing to refrain from using ibuprofen, aspirin or other NSAIDS (other than acetaminophen/paracetamol as rescue) or any other pain reliever (OTC or prescription) and Omega 3 fatty acids during the entire trial.
9.Willing to sign the informed consent and comply with study procedure.

Exclusion Criteria

1.Female subjects, who are pregnant, breast feeding or planning to become pregnant.
2.Subject has known allergy to non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin) or has a suspected hypersensitivity, allergy or other contraindication to any compound present in the study medication 3.History of underlying inflammatory arthropathy or severe RA or OA (VAS score greater than 70) 4.Subjects scheduled for any surgery within 3 months of completing the study 5.Recent injury in the area affected by OA of the knee (past 4 months) 6.History of Gout 7.History of congestive heart failure 8.Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies 9.History of Systemic Lupus Erythematosus (SLE) 10.High alcohol intake (>2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc) 11.History of psychiatric disorder that may impair the ability of subjects to provide written informed consent 12.Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit 13.Have taken any corticosteroid, indomethacin, glucosamine + chondroitin, within 3 months prior to the Treatment Period, Day 0 (Visit 1) or intra-articular treatment / injections with corticosteroid or hyaluronic acid or Omega-3 Fatty acids dietary supplements within 6 months preceding the treatment period.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Change from baseline to end of trial in WOMAC	Visit-1 to Visit-5

Secondary Outcome Measures

Name	Time	Method
Mean Change from baseline to end of trial in	VAS & LFI score and Primary knee flexion

Trial Locations

Locations (2): Bolineni Super Speciality Hospital
🇮🇳
Nellore, ANDHRA PRADESH, India
King George Hospital
🇮🇳
Visakhapatnam, ANDHRA PRADESH, India
Bolineni Super Speciality Hospital
🇮🇳Nellore, ANDHRA PRADESH, India
DrKBalakondaiah
Principal investigator
09440279700
bakolaxmi@rediffmail.com