An Open Labelled Prospective Noncomparative Single Arm Clinical Study to Evaluate Safety & Efficacy of Manyawin Capsule in Patients with Cervical Spondylosis - NI

SKM Siddha and Ayurveda Company India Private Limited0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年8月19日

试验速览

暂无简介。

•1) Male/female patients aged = 18 years and = 65 years at the time of consent;
•2) Patients with clinically confirmed diagnosis of cervical spondylosis within the
•last 6 months;
•3) Patients who have had one or more episodes of neck pain, neck stiffness attack
•on average per month for more than 3 months;
•4) Patients with NDI score of 20-35 at the time of screening;
•5) Patients with VAS score of >5 at the time of screening;
•6) Patients displaying a minimum of three of the following symptoms as evaluated
•by the physician:
•a) Cervical pain aggravated by the movement;
•b) Pain in occiput (back of the head), shoulder blades or upper limbs;
•c) Retro-orbital or temporal pain;
•d) Cervical stiffness;
•e) Localized tenderness, pain or numbness of upper limbs
•f) Dizziness or vertigo attributed to cervical pain;
•7) Patients who are willing to give voluntary written informed consent.

•1) Patients with known or suspected allergies/hypersensitivities to herbal or
•ayurvedic medicines;
•2) Patients who are clinically diagnosed with osteoarthritis, rheumatoid arthritis
•and ankylosing spondylitis;
•3) Patients with known history or diagnosis of advanced cervical radiculopathy,
•bony spurs, cervical myelopathy, cervical malignancies and lesions;
•4) Patients with severe congenital malformation of cervical vertebra; known
•history of cervical injury, cervical surgery, and implanted instrumentation;
•5) Patients with history of major neurological disorder such as a stroke,
•myasthenia gravis, muscular dystrophy, myotonic dystrophy and sclerosis;
•6) Patients with traumatic soft tissue injury to the cervical region in the past 1
•7) Patients who are known to be asthmatic or immunocompromised;
•8) Patients who are on NSAIDs, DMARDs or any other treatments for cervical
•pain for 1 month before screening;
•9) Patients with terminally ill and any other condition, in the opinion of the
•investigator, which would affect the safety of the patient;
•10) Female patients who are breast-feeding/ pregnant, or intends to become
•pregnant during the study;

发起方

SKM Siddha and Ayurveda Company India Private Limited