A Clinical Study to evaluate the Safety and Efficacy of Ossigen Capsules (Herbal Formulation)in treating Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Health Condition 1: null- Knee Osteoarthritis

• Registration Number: CTRI/2014/08/004878
• Lead Sponsor: SG Phyto Pharma Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

• Male and Female (of and between 18 and 60 years of age) subjects suffering from Knee Osteoarthritis.

• Be informed of the nature of the study and will give written informed consent.

• Able to communicate well with the investigator, to understand and comply with the requirements of the study.

• Patients who are suffering from Osteoarthritis

Exclusion Criteria

• Individuals who usually use an ambulation aid to walk such as a cane, crutch, walker or wheel chair.

• Amputation of foot or previous major trauma to foot that would raise concerns about whether an insert might worsen foot pain. Persons with foot lesions such as sores or ulcers in which redistributing load in the foot might be dangerous, will be excluded.

• Past history of deep venous thrombosis.

• Pain emanating more from back or hip than from knee

• Low pain score on WOMAC (less than or equal to 24)

• Individuals who have received corticosteroid injections in the month prior to starting the trial. Individuals who had bilateral total knee replacements (TKR) or planning for TKR in next 6 months for affected knee.

• Known other causes of arthritis including rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), gout, psoriatic arthritis, pseudo gout.

• Individuals with BMI > 30 kg/m2

• Any disease or condition which might compromise the hematopoietic, renal, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.

• History of autoimmune disorders â?? lupus erythematosis (SLE) or immunodeficiency diseases, including HIV.

• Subjects using NSAIDS.

• Presence of clinically significant abnormal laboratory results during screening.

• Pregnancy or not using appropriate means of contraception

• Use of any recreational drugs or a history of drug addiction.

• Patient not willing to sign informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified