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临床试验/CTRI/2024/07/071074
CTRI/2024/07/071074尚未招募3 期

A Comparative Clinical Study to Evaluate the Efficacy of Ashtakatvarataila with Gokshuraditaila Matrabasti and Dashamulakashaya as Shamanoushadhi in Gridhrasi vis- a -vis Sciatica

Dr Sangeetha N1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Assessing the efficacy between Ashtakatvara and Gokshuradi Taila matrabasti and Dashamulakashaya orally in relieving symptoms of sciatica like Radiating pain,stiffness

研究概览

简要总结

Gridhrasi is *ruja pradhana vataja nanatmaja vyadhi.*The cardinal signs and symptoms of Gridhrasi  are pain in chronological order from sphik, kati, prushta, uru, janu, jangha and pada stambha and muhurspandanaand sakthikshepa nigraha  Tandra gourava and arochaka are the symptoms present in kaphanubandha gridhrasi .

 The signs and symptoms of Gridhrasi is compared to Sciatica. It is defined as radiating pain along the course of sciatic nerve and is felt in the back,buttocks,posterior thigh,legs and foot. The lifetime incidence is reported between 10%to 40%,annual incidence of 1-5% and peak incidence occurs in in patient in their fourth decade. Occupational predisposition has been shown in machine operators, truck drivers and the workers who are subjected to physically awkward positions pertaining to their jobs.

Management of sciatica in contemporary science involves oral NSAID’S, muscle relaxants, oral cortico- steroids, lumbar traction, intravertebral steroid injection and surgery.

Management of pain is the first choice in sciatica for which NSAID’s are widely used. Long term  usage of NSAID’s leads to gastric pain, mucosal erosion/ulceration and blood loss are produced to varying extents. Procedures like intravertebral steroid injection and surgery are not economical to majority of the population.

Hence an approach which is effective, simple and affordable is required.

In Ayurvedic classics management of Gridhrasi includes basti karma, siravyadha,agnikarmaBasti is considered to be Hita Chikitsa in diseases caused due to vata,pitta,kapha,rakta, samsarga and sannipata doshas

Ashtakatvara and Gokshuradi taila are  having specific indication for Gridhrasi .

Dashamula Kashaya is having Tridoshagna, vedanastapaka and shothagna properties.

Hence in the present study, matra basti with Ashtakatvara taila  and Gokshuradi tailafollowed by Dashamula Kashayaorally is taken for comparative evaluation of the possible effect on Gridhrasi .

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

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

入选标准

  • Subjects with signs and symptoms of Gridhrasi vis-Ã -vis Sciatica between the age group of 20-60 irrespective of gender, religion, socio-economic status, occupation will be selected for the study.
  • Both freshly detected and treated cases of Gridhrasi vis-Ã -vis Sciatica (with the flush out period of seven days) will be taken for the study.
  • Fresh cases include freshly detected and untreated cases of Gridhrasi vis-a-vis Sciatica will be included.
  • Treated cases include already diagnosed as Gridhrasi vis-Ã -vis Sciatica, who had voluntarily discontinued the treatment with the flush out period of 7 days.

排除标准

  • Subjects with history of recent fracture (less than 1 year) of lumbar spine will be excluded.
  • Subjects who are unfit for administration of Matra basti will be excluded.
  • Pregnant and lactating women will be excluded.
  • Subjects suffering from Diabetes mellitus (RBS above 250mg/dl), uncontrolled hypertension (above 160/100 mm Hg) and other systemic disorders which will interfere with the intervention will be excluded.
  • Neoplastic/Infective/congenital conditions of the lumbar spine will be excluded.

结局指标

主要结局

Assessing the efficacy between Ashtakatvara and Gokshuradi Taila matrabasti and Dashamulakashaya orally in relieving symptoms of sciatica like Radiating pain,stiffness

时间窗: at baseline,9th day(mid assessment), 39th day(post assessment)

次要结局

  • To evaluate the efficacy of Ashtakatvara and Gokshuradi Taila matra basti followed by Dashamula Kashaya orally in reliving symptoms of sciatica like radiating pain,stiffness(second assessment 9th day and third assessment 39th day)

研究者

发起方
Dr Sangeetha N
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

Dr Sangeetha N

Government Ayurveda Medical College ,Mysuru

研究点 (1)

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