A Randomised Controlled Clinical Trial To Evaluate Analgesic Effect Of Dashanga Ghrita In The Management Of Post Haemorrhoidectomy Pain.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessment will be made with the following parameters:
研究概览
简要总结
Postoperative 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 drawbacks. Dashanga ghrita has been used in Ayurvedic practice for analgesia -as per Sahasra yogam reference. It is known to relieve pain and can be used to supplement analgesia and also get rid of adverse effects of modern analgesic drugs.
There are very few Ayurvedic treatments available for post-haemorrhoidectomy pain management. Therefore, this study is planned to establish and to screen the effect of Dashanga Ghrita as an Ayurvedic treatment modality for post-haemorrhoidectomy pain.
This study is a randomized, interventional, parallel-group trial, comparing the analgesic effect of Dashanga Ghrita & plain ghrita;20ml intra-rectally for 07 days from 1st post-operative day in 30 patients 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 the abovementioned gradation format.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Operated participants of haemorrhoidectomy after initiation of Pain / after 24 hours of surgery if rescue drug administered.
- •Age group between 18 to 60 yrs., irrespective of gender, religion and socioeconomic status.
排除标准
- •Participants suffering from other systemic and metabolic diseases like Diabetes mellitus, tuberculosis, HIV, HbsAg, anaemia, chronic renal failure etc.
- •Pregnant Lady & Lactating mother.
- •Participants not willing for intra rectal application of the drug.
结局指标
主要结局
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.
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.
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
- impact on complete pain subsided(every 7th day)
研究者
Dr Sachin Dineshbhai Kar
G.J. Patel Institute Of Ayurvedic Studies And Research.