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临床试验/CTRI/2017/03/008229
CTRI/2017/03/008229已完成不适用

A Comparative evaluation of anaesthetic & analgesic effect of Yashtimadhu ghrita & ghrita in the management of post haemorrhoidectomy pain.

Dr Hirenkumar B Mistry1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Subjective parameters: Pain

研究概览

简要总结

Post opertive pain is Nociceptive; anticipated unavoidable physiological pain which is caused due to tissue trauma. Drugs such as NSAIDs and opioids are used for post operative management but are associated with their own drawbacks. Yashtimadhu ghrita has been in use in Ayurvedic practice for analgesia - shashtra nipatjanya vedana. It is known to relieve pain and can be used to supplement anaesthesia and also get rid of adverse effect of modern analgesic drugs.

There are very few Ayurvedic treatments available for post haemorrhoidectomy pain management. Therefore, this study is planned for establishing and to screen the effect of Yashtimadhu Ghrita as Ayurvedic treatment modality for post haemorrhoidectomy pain.

This study is randomised, intervantional, parallel group trail, comparing the anesthetic and analgesic effect of Yashtimadhu ghrita & plain ghrita;20ml intra-rectally  for 15 days from 1st post operative day in 60 patient of post haemorrhoidectomy pain.

The primary outcome will be measured by subjective parameters pain intensity wise analyzed on VAS

The secondary outcome will be measured by pain duration after defecation analyzed on gradation mention as above format.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

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

入选标准

  • •Operated patients of haemorrhoidectomy complaining of Pain. Age group.
  • •between 16-60 yrs, irrespective of sex, religion and socio-economic status.

排除标准

  • •Age<16 yrs & age > 60 yrs.
  • •Patients suffering from other systemic and metabolic diseases like Diabetes mellitus, tuberculosis, HIV, HbsAg, anaemia, chronic renal failure etc.
  • •Patients not willing for local application intra rectally (Intra-anal) of Yashtimadhu Ghrita.

结局指标

主要结局

Subjective parameters: Pain

时间窗: Assessment of pain will be done after post operative anesthesia withrawal every 2 hrs upto 8hrs and before treatment & after treatment upto 7 days from 1st post operative day. | Follow up will be taken 0-7thday, 14th & 21st day.

Assessment will be made with the following parameters:

时间窗: Assessment of pain will be done after post operative anesthesia withrawal every 2 hrs upto 8hrs and before treatment & after treatment upto 7 days from 1st post operative day. | Follow up will be taken 0-7thday, 14th & 21st day.

The characteristic feature of pain will be documented and analyzed based on VAS.

时间窗: Assessment of pain will be done after post operative anesthesia withrawal every 2 hrs upto 8hrs and before treatment & after treatment upto 7 days from 1st post operative day. | Follow up will be taken 0-7thday, 14th & 21st day.

Pain will be assessed by Intensity and duration-after defecation.

时间窗: Assessment of pain will be done after post operative anesthesia withrawal every 2 hrs upto 8hrs and before treatment & after treatment upto 7 days from 1st post operative day. | Follow up will be taken 0-7thday, 14th & 21st day.

次要结局

  • Criteria for Pain:(INTENSITY - VAS (VISUAL ANALOUGE SCALE))

研究者

发起方
Dr Hirenkumar B Mistry
申办方类型
Other [Parul Institute Of Ayurveda Limda Vadodara]

研究点 (1)

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