An Open Label, Prospective, Multicentric, Non-Comparative, Single Arm Study to Evaluate the Efficacy, Safety and Tolerability of Ayurvedic Proprietary Medicine- Rasnalasoona in the Management of Cervical Spondylosis in Adult Subjects

Dhathri Ayurveda Private Limited0 个研究点目标入组 40 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Male and female subjects between the ages of 21 and 45 years (both ages inclusive).
•2.Subjects with clinically and radiologically confirmed diagnosis of cervical stenosis , cervical spondylosis or cervical radiculopathy within the last 6 months.
•3.Neck Disability Index: Screening Score of 20-35.
•4.Visual Analogue Scale: Screening Score of >=5.
•5.Subjects who have had one or more episodes of neck pain, neck stiffness attack on average per month for at least 3 months.
•6.Subjects displaying a minimum of three of the following symptoms as evaluated by the physician.
•i.Cervical pain aggravated by movement
•ii.Pain in occiput, shoulder blades or upper limbs.
•iii.Retro-orbital or temporal pain.
•iv.Cervical stiffness.
•v.Localised tenderness, pain or numbness of upper limbs.
•vi.Dizziness or vertigo attributed to cervical pain.

•1.Subjects with known or suspected allergies/hypersensitivities to herbal or Ayurvedic medicines.
•2.Subjects who are clinically diagnosed with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis.
•3.Subjects with known history or diagnosis of advanced cervical radiculopathy, bony spurs, cervical myelopathy, cervical malignancies, lesions.
•4.Subjects with known history of cervical/spinal surgery, trauma, fracture, tumors, infections, instability, deformity or whiplash within the last 2 years.
•5.Subjects with history of major neurological disorder such a stroke, myasthenia gravis, muscular dystrophy, myotonic dystrophy, sclerosis.
•6.Subjects with cardiac, hepatic and renal dysfunction.
•7.Subjects with diagnosis of diabetes mellitus or hypertension.
•8.Subjects with traumatic soft tissue injuries to the cervical region in the last 1 year.
•9.Subjects who are known to be asthmatic or immunocomprised.
•10.Subjects who are on regular DMARD, NSAID or other treatments for cervical pain for 1 month before screening.
•11. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
•12.Subjects who are known/reported to be pregnant, lactating, planning a pregnancy or unwilling to practice double barrier contraceptive method.
•13.Subjects who in the opinion of the investigator is deemed unfit to participate in the study.

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