A Randomized, Double Blinded, Placebo Controlled, Two Arm, Single- Centric, Clinical Trial to Assess the Safety and Efficacy of Axtragyl® in Subjects Experiencing Joint (Knee) Pain Compared to Placebo. - NI

GIELLEPI S.p.A0 个研究点目标入组 90 人开始时间: 待定最近更新: 2024年4月29日

试验速览

暂无简介。

•1.Physically active healthy subjects (both women and men) without any joint’s diseases including osteoarthritis as well as rheumatoid arthritis.
•2. Adult subjects (18 - 60 years old) experiencing joint (knee) pain (not associated with acute injury or long-standing disease).
•3. Subjects should not have knee pain at rest but mild to moderate knee joint pain after 6 min walk test at a moderate-to brisk pace.
•4. BMI <27.
•5. Subjects with normal ECG readings on screening.
•6. Subjects with normal creatine kinase.
•7. Patients ready to give written informed consent and willing to
•comply with the study protocol.

•1.Consuming any herbal supplement/drug, including both systemic and local ones, showing anti-inflammatory and/or analgesic action.
•2. Subjects with acute muscle spasms who need parenteral therapy, surgery or hospital admission for management.
•3. Subjects with uncomplicated acute soft tissue injury of the upper or lower extremity, including acute injuries of ligaments, tendons, or muscles.
•4. Subjects with known history or diagnosis of osteoarthritis and rheumatoid arthritis as well as other joint disease.
•5. Subjects with joint surgery during 3 months before screening.Subjects with uncontrolled hypertension (Diastolic blood pressure more than or equal to 110 mmHg and/or systolic blood pressure; more than or equal to 180 mmHg).
•7. Cancer and any other diseases interfering with study procedures or safety.
•8. Pregnant or lactating females or absence of effective contraceptive methods for females of childbearing potential.
•9. Presence of any severe medical or psychological condition or
•chronic condition/inflammation/infection that in the opinion of the investigator would compromise the patient’s safety or successful participation in the study.
•10. Participation in any other clinical study within 30 days of screening.

发起方

GIELLEPI S.p.A