A controlled clinical study to evaluate the efficacy of Jatyadighrita suppository in post operative pain management of Anorectal disorders
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 2.Baurning sensation
研究概览
简要总结
Ano rectal disorders are one of the common reasons for visits to both primary care physicians and gastroenterologists, these include fissure-in-ano, hemorrhoids and fistula-in-ano, which in advanced condition requires surgery.
In contemporary science diclofenac sodium suppositories which belong to NSAID group are used to relive the pain, but they have adverse effects like headache, drowsiness, rectal irritation, rectal bleeding and abdominal pain.
In Ayurveda, Matrabasti and Sneha vartis are used to relieve post operative pain. Matrabasti usually requires assistance and the level of comfort is comparatively less because of possibility of oozing out of administered taila.
Contemplating on this, here an attempt will be made for post operative pain management through Jatyadi Ghrita suppository.
Jatyadi ghrita is choosen for the present study, which will be modified into simple, cost effective, patients friendly in Suppository form. The results obtained from the clinical study will be compared with the results obtained from the the standard group which will be treated with Diclofenac suppositories.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing fissurectomy, hemorrhoidectomy, fistulotomy.
- •Patients between the age group of 20 to 60 years were included in the study.
排除标准
- •Fissure/hemorrhoid/fistula in ano with Inflammatory Bowel Disease and Crohns disease.
- •Patients suffering from systemic diseases like DM, Tuberculosis, Rheumatoid arthritis.
- •Positive cases for Human Immunodeficiency Virus (HIV), Venereal Disease Research Laboratory (VDRL) and hepatitis-B
- •The post operative cases with complications like severe bleeding, Wound sepsis.
结局指标
主要结局
2.Baurning sensation
时间窗: 0th before the day of surgery | Everyday after surgery for 5 days
1.Pain
时间窗: 0th before the day of surgery | Everyday after surgery for 5 days
次要结局
- 1.Sphincter tone(2.Tenderness)