OLNP-08 for the Treatment in Reducing Symptoms of Knee Osteoarthritis

Not yet recruiting

• Conditions: Symptoms ofKnee Osteoarthritis

• Registration Number: CTRI/2017/06/008874
• Lead Sponsor: Olene Life Sciences Private Limited

Brief Summary

Osteoarthritis is a common, chronic, progressive, skeletal, degenerative disorder, which commonly affects the knee joint. Osteoarthritis disables about 10% of people who are older than 60 years, compromises the quality of life of more than 20 million Americans, and costs the United States economy more than $60 billion per year.



OLNP-08 is a unique and novel formulation of natural active ingredient, which is found to possess significant anti-inflammatory and anti-oxidant activity. So this randomized, double blind, placebo control, parallel group study is designed to access the efficacy and safety of OLNP-08 capsule versus placebo for the treatment of Osteoarthritis. A total 50 subjects will be randomized with 1:1 allocation for test group (OLNP-08) and for control group (Placebo) for a period of approximately 60 days. During the study, subjects will visit the study site at screening visit (Day -7 to 0) randomization visit (Day 1), visit 2 (Day 7), visit 3 (Day 15), visit 5 (Day 30) and at final visit (Day 60).



The efficacy will be accessed on the basis of WOMAC score and VAS score. Safety parameters will be evaluated on basis of change in vitals, Laboratory parameters and adverse events.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2017-06-19
• Study Start: 2017-06-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 1. Male and female subjects 40 – 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 or 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 year 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. Drug naive subjects or subjects willing to refrain from using ibuprofen, aspirin or other NSAIDS (other than acetaminophen/paracetamol as rescue) or any other pain reliever including topical application(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

• Female subjects, who are pregnant, breast feeding or planning to become pregnant.
• 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 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, ngastrointestinal, 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 30days 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 in WOMAC score	Screening visit (Day 07 to 0), Randomization | visit (Day 1), Visit 2 (Day 7), Visit 3 (day 15), | Visit 4 (Day 30) and Visit 5 (Day 60)

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Visual Analog Scale	(VAS)
Change from baseline in WOMAC subscale	score (pain, stiffness and physical function)

Trial Locations

Locations (1)

Maharaja Agrasen Hospital; 🇮🇳 Delhi, DELHI, India

Maharaja Agrasen Hospital

🇮🇳Delhi, DELHI, India

Dr Alok Kalyani

Principal investigator

alokkalyani@gmail.com