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临床试验/CTRI/2020/03/024166
CTRI/2020/03/024166尚未招募2 期

An open clinical evaluation on THANDAGAVADHAM (Lumbar Spondylosis) treated with VARMAM and AANAI THIPILI DHRAVAGAM (Internal) and KAYATHIRUMENI ENNAI (External)

Government siddha medical college chennai1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年3月24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
90
试验地点
1
主要终点
Reduction of pain is assessed by Visual Analogue Scale,Improvement in range of movements, stiffness is assessed by using Oswestry Disability Index. Comparing the clinical symptoms and physical examinations before and after treatment.

研究概览

简要总结

This is a phase II, non-randomized, comparative an open clinical evaluation of Varmam and Siddha trial drugs "Aanai thipili dhravagam" (internal) and "Kayathirumeni ennai" (external) for Thandagavadham (lumbarspondylosis). The

dosage of internal medication Aanai thipili dhravagam is 2 ml along with 30ml of water and will be administered twice a day after a meal. The time period of medication will be around 21 days and a sufficient amount of Kayathirumeni ennai will be given for 21days . The sample size for this study is 90 which will be categorized into 3 groups.  The first group will be given Varmam therapy, the second group will be given both internal and external medication and the final group will be given internal, external and varmam therapy. The trial drug Aanai thipili dhravagam contains some active herbs that possess anti-inflammatory, analgesic which will be helpful to reduce the symptoms of Lumbar spondylosis.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
25.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients having any one of the symptoms of lower back pain radiating to the lower extremities anteriorly, tenderness, numbness.
  • Limitation of lower back movements.
  • Patients who is willing to undergo necessary investigations.

排除标准

  • 未提供

结局指标

主要结局

Reduction of pain is assessed by Visual Analogue Scale,Improvement in range of movements, stiffness is assessed by using Oswestry Disability Index. Comparing the clinical symptoms and physical examinations before and after treatment.

时间窗: 21 days

次要结局

  • Assessed by comparing safety profile before and after treatment.(21 days)

研究者

发起方
Government siddha medical college chennai
申办方类型
Government medical college

研究点 (1)

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