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临床试验/CTRI/2023/04/051320
CTRI/2023/04/051320尚未招募2/3 期

A comparative study of healing effect of Panchatikta ghrita guggulu and Shigru Guggulu in fistula in ano with partial fistulotomy and Ksharsutra application - A randomised controlled trial

All India Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年4月17日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
80
试验地点
1
主要终点
Complete uneventful healing of the fistulotomy wound

研究概览

简要总结

Fistula in ano is a very difficult disease to tackle and cure. Ksharsutra therapy provides a ray of hope to the suffering humanity as it ensures minimal invasion and minimal recurrence rates. The healing after partial fistulotomy and ksharsutra application has been an issue on account of contamination in the wound. The wound healing can be augmented by using Panchtikta Ghrita Guggulu as an oral drug in these patients. The Shigru guggulu has been in use post operatively in these cases. Panchatikta ghrita guggulu is a potent drug for the use in various dermatosis and it can be studied in comparison to Shigru guggulu. The dose shall be same for both drugs and that is 500 mg twice a day for 30 days. The patients shall be selected from OPD and IPD of department of Shalya tantra, All India Institute of Ayurveda and the groups shall be allocated on random basis. Shigru Guggulu shall be the control. Statistical calculations shall be carried out in terms of mean (x), SD, SE, Z test and finally the results shall be incorporated in terms of probability (p)

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

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

入选标准

  • Patients of Primary Fistula in ano (Cryptoglandular infection) of either gender.

排除标准

  • 1 Secondary Fistula in ano 2 Age below 18 years and above 60 years 3 Severe anaemia 4 Anorectal carcinoma 5 Osteomyelitis 6 Inflammatory bowel disease 7 Pregnancy 8 Diabetes mellitus 9 Tubercular fistula in ano 10 Hypertension 11 HIV HBsAg and HCV positive patients 12 patients who are not willing to part of study.

结局指标

主要结局

Complete uneventful healing of the fistulotomy wound

时间窗: First week, first month, Second month, Third month

次要结局

  • good scar without any hypertrophy(three months)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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