Clinical Study to Evaluate the Efficacy and Safety of Ayurvedic Medicine Rasnalasoona for Cervical Spondylosis in Adults.
- Conditions
- Health Condition 1: M478- Other spondylosis
- Registration Number
- CTRI/2016/05/006954
- Lead Sponsor
- Dhathri Ayurveda Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 40
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Neck Disability Index: Reduction in screening scores by â?¥50% at end of study. <br/ ><br>2.Visual Analogue Scale: Improvement by â?¥4 scores at end of study. <br/ ><br>3.Radiology Assessments: Physicianâ??s Impression of Change Scale: Score of 2 or 1 at end of study. <br/ ><br>4.Quality of life Questionnaire: Improvement by â?¥10 scores at end of study. <br/ ><br>Timepoint: 1. Neck Disability Index: Visit 0 (Screening Assessment), Visit 2,3 and 4 (6 weeks) <br/ ><br>2. Visual Analogue Scale: Visit 0 (Screening Assessment), Visit 2,3and4 (6 weeks) <br/ ><br>3. Radiological Assessments: Visit 4 (End of Study) <br/ ><br>4. Quality of life Questionnaire: Visit 1(Enrollment), Visit 2,3, and 4 (6 weeks)
- Secondary Outcome Measures
Name Time Method 1.Neck Disability Index: Reduction in screening scores by 49-25% at end of study. <br/ ><br>2.Visual Analogue Scale: Improvement by 2 scores at end of study. <br/ ><br>3.Radiology Assessments: Physicianâ??s Impression of Change Scale: Score of 3 at end of study. <br/ ><br>4.Quality of life Questionnaire: Improvement by 5-9 scores at end of study. <br/ ><br>Timepoint: 1.Neck Disability Index: Visit 0 (Screening Assessment), Visit 2,3 and 4 (6 weeks) <br/ ><br>2.Visual Analogue Scale: Visit 0 (Screening Assessment), Visit 2,3and4 (6 weeks) <br/ ><br>3.Radiological Assessments: Visit 4 (End of Study) <br/ ><br>4.Quality of life Questionnaire: Visit 1(Enrollment), Visit 2,3, and 4 (6 weeks) <br/ ><br>