CTRI/2023/10/059140招募中4 期
A prospective, multicenter, interventional, phase IV clinical trial to evaluate the efficacy and safety of Pravek Rumakalp® tablets for the treatment of musculoskeletal pain and inflammation - NI
Pravek Kalp (P) Limite0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1.Subjects of either sex in the age range of 18 to 60 years (both
- •2. Subjects able and willing to give written informed consent form.
- •3. Subjects suffering from acute pain and inflammation associated
- •with prolapsed intervertebral disc, sprains and dislocations,
- •spondylosis (lumbar, cervical, ankylosing spondylosis), spinal
- •stenosis, periarthritis, frozen shoulder, prepatellar bursitis,
- •spondylolisthesis, Low-back pain, tendonitis, tenosynovitis,
排除标准
- •1. Subjects known, or thought to be hypersensitivity to study drugs
- •2. Subjects with concurrent use of corticosteroids
- •3. Subjects with medication or indication that might point to an
- •increased risk, associated with study participation or study drug
- •administration or may interfere with the interpretation of study
- •results and, in the judgment of the study personnel, would make
- •the subject in appropriate for inclusion
- •4. Subjects participated in other clinical trials from last three
- •months or during study participation
- •5. Subjects with history of epilepsy or at risk of seizures or taking
- •anti-epileptic drugs
- •6. Pregnant, lactating women or women of child bearing age who
- •are not using an acceptable method of birth control
- •7. Subjects with galactose or fructose intolerance
- •8. Subjects with severe renal impairment, including those receiving
- •9. Subjects with active liver disease, including those with primary
- •biliary cirrhosis and unexplained persistent liver function
- •abnormalities.
- •10. Subjects with pre-existing gall bladder disease
- •11. Subjects with active peptic ulcer disease
- •12. Pre or post-surgical cases
研究者
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