To evaluate safety & efficacy of Manyawin Capsule in patients with Cervical Spondylosis

Phase 4

Completed

• Conditions: Health Condition 1: M478- Other spondylosis

• Registration Number: CTRI/2023/07/055033
• Lead Sponsor: SKM Siddha and Ayurveda Company India Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-02-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

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.

Exclusion Criteria

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

year;

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;

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment-emergent adverse events (TEAEs) (serious/non-serious, expected/unexpected, related/non-related).Timepoint: Day 01, Day 60, Day 120, Day 180, Day 210.

Secondary Outcome Measures

Name	Time	Method
1) Change in Visual Analogue Scale (VAS) score for neck pain, neck stiffness, radiating pain towards shoulders /arms, tingling <br/ ><br>sensation of fingers, headache/vertigo <br/ ><br>2) Change in Neck Disability Index (NDI) Score <br/ ><br>3) Change in Short-form McGill Pain Questionnaire (SF-MPQ) <br/ ><br>4) Quality of life Questionnaire SF-36Timepoint: Day 1, Day 60, Day 120, Day 180, Day 210.