An open Label, non-randomised, clinical study to evaluate the efficacy and safety of homeopathic formulation of Spondin drops in patient with Cervical spondylosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Improvement in Signs and symptoms of Cervical Spondylosis
研究概览
简要总结
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), Day 20, Day 40 and Day 60.
100 subjects will be enrolled.
Subjects in study will receive active Investigational Product and advised to take 15 Drops in half cup of lukewarm water thrice a day after food Physical examination and Demographics will be recorded at the screening time.
Physical examination and monitoring will be continuing Day 20, Day 40 and Day 60.
Vitals will be recorded on all the visits.
X-Ray for (Cervical region) at the baseline and final visit
Visual Analog Scale (VAS) Score on all visits
(Intensity of pain will be graded from 0-9. Pain, Intensity and X-ray changes will be assessed in each case)
Adverse events will be monitored up to 60 days and will be recorded on Day 20, Day 40 and Day 60. A buffer period of ±3 days will be allowed for every visit and beyond which it will be considered as a protocol deviation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •The Inclusion criteria are as follows (“Yes†to all the following will allow the subjects to be included into study)
- •Age: Adult-Above 18 years to Below 60 years, both male and female
- •Willing to sign written inform consent
- •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
- •Confirmation of Cervical Spondylosis by X-ray- Cervical region.
排除标准
- •Name The exclusion criteria are as follows (“Yes†to any one of the following will allow PI to exclude the subject from enrolling into the study
- •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.
结局指标
主要结局
Improvement in Signs and symptoms of Cervical Spondylosis
时间窗: 60 days
Safety is assessed through the number of adverse events, the number and nature of abnormal laboratory results.
时间窗: 60 days
次要结局
- Symptomatic relief from clinical symptoms of Cervical Spondylosis(Mean Change in Visual Analog Scale (VAS) Chart score from baseline to end of treatment.)