A Clinical Study of Easyclimb G and Easyclimb H for the management of knee Osteoarthritis.

Not Applicable

Completed

Registration Number: CTRI/2018/04/013183

Lead Sponsor: Green Chem Herbal Extracts Formulations

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Ambulatory, male and female subjects in the age range of 35 â?? 70 years.

2.Patients with mild to moderate Knee Osteoarthritis, who are clinically detected and/or diagnosed through radiological evidence (Grade 0, I & II through Kellgren- Lawrence Scale) for Primary knee joint. (IF subject has gone for X-Ray Diagnosis prior 15 days to screening, that X-ray will be accepted as an evidence)

3.Stable primary hypertensive and newly diagnosed diabetic (type II) subjects with first line of medication or without any medication may be recruited (based on the investigatorâ??s decision).

4.Satisfactory medical assessment with no clinically significant or relevant abnormalities except for study related disease condition/s.

5.Be willing to refrain from taking ibuprofen, aspirin or other NSAIDS (other than paracetamol as rescue medication) or any other pain reliever (OTC or prescription) during the entire trial period

6.Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-child bearing potential must be amenorrheic for at least 1 year or had a hysterectomy or bilateral oophorectomy or tubectomy.

7.Subjects willing to sign the informed consent and comply with study procedure.

Exclusion Criteria

1.Subjects with any possible signs/ indications/ history of dislocations and quadriceps tendons tear.

2.Subjects with non-degenerative joint diseases or other joint diseases (e.g., Gout) which will interfere with the evaluation of OA.

3.Subjects with history of autoimmune disorders such as rheumatoid arthritis, systemic lupus erythematous, etc.

4.Subjects with history of knee or hip joint replacement surgery, or any hip or back pain which interferes with ambulation.

5.Subjects expecting any surgery during the study duration.

6.Subjects with history of known allergy to non-steroidal anti-inflammatory drugs (NSAIDs) or has a suspected hypersensitivity, allergy or sensitivity to herbal products.

7.Subjects who have consumed any corticosteroid, indomethacin, glucosamine and chondroitin, within 3 months prior to the Treatment Period or intra-articular treatment / injections with corticosteroid or hyaluronic acid within 6 months preceding the treatment period.

8.Subjects with the evidence or history of clinically significant condition/s of haematological, renal, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, malignancies or severe thyroid disorders (as per the judgment of the Investigator).

9.Subjects with high alcohol intake ( >2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.).

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

11.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.

12.Subjects who have any physical disability which could interfere with their ability to perform the functional performance measures included in this protocol.

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

14.Female subjects, who are pregnant, breast feeding or planning to become pregnant during the course of the study.

15.Subjects with HIV Positive status.