A clinical trial to study the efficacy novel herbal composition in Reducing Symptoms of Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Health Condition 1: null- Osteoarthritis of Knee

• Registration Number: CTRI/2014/01/004337
• Lead Sponsor: aila Nutraceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

•Ambulatory, male and female subjects 40 â?? 75 years of age with a Body Mass Index (BMI) of approximately 18 to 30 kg/m2

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

•Subjects with radio graphic evidence by Kellgren - Lawrence grade 1 to grade 2

•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

•VAS score during the most painful knee movement between 40-70 mm

•Subjects having mild-to-moderate pain not adequately or completely controlled with anti-inflammatory drugs

•Results of screening are within normal range or considered not clinically significant by the Principal Investigator

•Be willing to refrain from taking Ibuprofen, Aspirin or other NSAIDs (other than Acetaminophen / Paracetamol as rescue medication) or any other pain reliever (OTC or prescription) during the entire trial.

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

History of underlying inflammatory arthropathy or severe RA or OA (VAS score greater than 70)

Subjects scheduled for any surgery within 3 months of completing the study

Recent injury in the area affected by OA of the knee (past 4 months)

History of Gout

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 within 6 months preceding the treatment period.

History of congestive heart failure

Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies

History of Systemic Lupus Erythematous (SLE)

High alcohol intake (2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)

History of psychiatric disorder that may impair the ability of subjects to provide written informed consent

Participation in any other trials involving investigational or marketed products within 30days prior to the Screening Visit

Have taken Acetaminophen / Paracetamol, Ibuprofen, Aspirin or other NSAIDs or any other pain reliever (OTC or prescription) or any natural health product, (excluding vitamins), within 7 days prior to the Screening Visit(Visit 1)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Change from the baseline to the end of the trial period in WOMACTimepoint: Screening, Day 7,21 and 37

Secondary Outcome Measures

Name	Time	Method
Mean Change from the baseline to the end of the trial period in VAS & LFITimepoint: Screening, Day 7,21 and 37