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临床试验/CTRI/2024/04/065320
CTRI/2024/04/065320尚未招募2/3 期

Assessment of efficacy of Bhagandar vinashan taila pooran in Bhagandar

Tazeen Choudhary1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年4月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
48
试验地点
1
主要终点
SUBJECTIVE

研究概览

简要总结

To assess the effect of bhagandarvinasha taila pooran in bhagandar wsrt fistula in ano for 21 days

Sample size 48

Subjective criteria

Pain (Absent/Present )

Tenderness(Absent/Present)

Itching (Absent/Present)

Objective criteria

1 Length of track

• Grade 0 – Absence of track

• Grade 1 – upto 1 cm of track.

• Grade 2 – upto 2 cm of track.

• Grade 3 – upto 3 cm of track.

2 Discharge

• Grade 0- No Discharge

• Grade 1- Serous Discharge

• Grade 2- Serosanguinous Discharge

• Grade 3- Sanguinous Discharge

• Grade 4- Purulent Discharge.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
1.00 Month(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patient suffering from Fistula in ano specially Of low level type Patient irrespective of age and sex have been included.

排除标准

  • Complex fistula in ano High level fistula in ano Multiple fistula in ano patient with HIV HBsAg positive Other systemic disorder Fistula developing secondary to disease like Ulcerative colitis crohns disease Tuberculosis malignancy uncontrolled DM etc.

结局指标

主要结局

SUBJECTIVE

时间窗: 21 days

Pain (Absent/Present )

时间窗: 21 days

Tenderness(Absent/Present)

时间窗: 21 days

Itching (Absent/Present)

时间窗: 21 days

OBJECTIVE

时间窗: 21 days

1-Length of track

时间窗: 21 days

Grade 0 – Absence of track

时间窗: 21 days

Grade 1 – upto 1 cm of track.

时间窗: 21 days

Grade 2 – upto 2 cm of track.

时间窗: 21 days

Grade 3 – upto 3 cm of track.

时间窗: 21 days

2-Discharge

时间窗: 21 days

Grade 0- No Discharge

时间窗: 21 days

Grade 1- Serous Discharge

时间窗: 21 days

Grade 2- Serosanguinous Discharge

时间窗: 21 days

Grade 3- Sanguinous Discharge

时间窗: 21 days

Grade 4- Purulent Discharge.

时间窗: 21 days

次要结局

  • To avoid use of antibiotics for long duration & long recovery time(To prevent infection)

研究者

发起方
Tazeen Choudhary
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Tazeen Choudhary

Dr G D Pol foundation Y M T Ayurvedic medical college and hospital

研究点 (1)

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