CTRI/2021/02/031215尚未招募2 期
A prospective open labelled non randomized phase II clinical trial of Mavilingapattai Kudineer in the management of Thandagavatham (Lumbar Spondylosis)
Government Siddha Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年2月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction of the symptoms of the pain in lumbar and lower limbs.
研究概览
简要总结
The study is a prospective open labelled phase II non-randomized clinical study to evaluate the therapeutic efficacy of Mavilingapattai Kudineer in the management of Thandagavatham (Lumbar Spondylosis). The trial drug will be administered orally at the dose of 30 ml after the food, twice a day for a period of 45 days in 60 patients. The trial period of 12 months will be carrying out in Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli, Tamilnadu.
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
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient presenting with pain and stiffness in the lumbar region, radiating pain to buttocks and lower limbs, pain aggravating on forward and backward bending.
- •Patient with positive Schober and Straight Leg Raising test.
- •Patient complaining of back pain functional scale score should be range from below 30.
排除标准
- •Age below 30 and above 60 years.
- •Tuberculosis of spine.
- •Systemic Lupus Erythematosus Chronic Kidney Disease Fracture of spine Congenital Spino vertebral deformities Mixed connective disease Pregnancy Lactating mother Chronic Liver Disease.
结局指标
主要结局
Reduction of the symptoms of the pain in lumbar and lower limbs.
时间窗: 45 days
Improvement of the range of movements in the Lumbar and lower limbs.
时间窗: 45 days
次要结局
- Evaluation of additional effects and siddha(parameters changes in Thandagavatham)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
2 期
A clinical study on Sundiyathi chooranam in the management of Swasa kasam(Bronchial Asthma)CTRI/2020/05/025413Government Siddha Medical College and hospitall60
终止
2 期
To Assess the Efficacy and Safety of RVT-1401 in the Treatment of Warm Autoimmune Hemolytic Anemia (ASCEND-WAIHA).Warm Autoimmune Hemolytic AnemiaNCT04253236Immunovant Sciences GmbH5
Unknown
2 期
Sintilimab to Prevent High-risk Oral Premalignant Lesions CancerizationOral Cavity CancerMouth NeoplasmPrecancerous ConditionsNCT04065737Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University29
招募中
2 期
A clinical study on PALATTIRIKKATI CURANAM in the management of Atitulam (Obesity)CTRI/2020/05/025001GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITA
已完成
2 期
A Phase II Study to Evaluate the Efficacy of TKI258 for the Treatment of Patients With FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial CancerSolid Tumors and Advanced Endometrial CancerEndometrial CancerSecond-line TreatmentVEGFNCT01379534Novartis Pharmaceuticals53