Health Condition 1: M478- Other spondylosis
Conditions
Interventions
Intervention1: Spondin Drops: All eligible subjects who meet the Inclusion and Exclusion Criteria will be enrolled into the study will have to visit the study site on screening, Day 0 (Baseline visit)
Sponsors
Bhargava Phytolab Limited
Milagro Clinical Research
Eligibility
Inclusion criteria
Inclusion criteria: The Inclusion criteria are as follows (â??Yesâ?? to all the following will allow the subjects to be included into study) 1. Age: Adult-Above 18 years to Below 60 years, both male and female 2. Willing to sign written inform consent 3. Patients recently diagnosed with Cervical spondylosis, the following signs and symptoms Pain in neck and Referred pain (occiput, between the shoulder blades, upper limbs) Pain in Back and Shoulder Tenderness Difficulty in neck movements Dizziness or vertigo 4. Confirmation of Cervical Spondylosis by X-ray- Cervical region
Exclusion criteria
Exclusion criteria: The exclusion criteria are as follows (â??Yesâ?? to any one of the following will allow PI to exclude the subject from enrolling into the study 1. Severe neurological conditions like severe neuropathy 2. Inflammatory diseases like Osteoarthritis, Rheumatoid Arthritis and Ankylosing spondylitis 3. Evidence of a specific pathologic condition herniated disc and any malignancy. 4. Past h/o Fracture 5. Past h/o Neck surgery 6. Inability to sign inform consent 7. Patients with k/h/o DM and HTN 8. H/o renal, hepatic or hematopoietic disorder or severe cardiac insufficiency 9. K/h/o hypersensitivity to herbal extracts or dietary supplements 10. Pregnant women, lactating women and women of childbearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Signs and symptoms of Cervical Spondylosis Safety is assessed through the number of adverse events, the number and nature of abnormal laboratory results. Timepoint: 60 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptomatic relief from clinical symptoms of Cervical Spondylosis Mean Change in Visual Analog Scale (VAS) Chart score from baseline to end of treatment. Timepoint: 60 days | — |
Countries
India
Contacts
Public ContactRajeshwari Sorte
Milagro Clinical Research
Outcome results
None listed