Randomized Open Control Clinical Study to evaluate the healing effect of Syandan Tail in the management of Bhagandar with special reference to Fistula in Ano.
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain,Discharge,Granulation of the fistula tract,Local tenderness,Healing time
研究概览
简要总结
This Study is RANDOMIZED OPEN CONTROLLED CLINICAL STUDY TOEVALUATE HEALING EFFECT OF SYANDAN TAIL IN THE MANAGEMENT OF BHAGANDAR WITH SPECIALREFERENCE TO FISTULA IN ANO.
| Intervention: |
| Group |
Trial Group
Control Group
|Drug
Syandan Tail
Sucralfate,metronidazole with Lignocaine Hydrochloride
Cream
|Form
Tail
Cream
|Dose
Nadi Pooran (Instillation) as per size of tract
Nadi Pooran (Instillation) as per
size of tract
|Time of administration
2nd to 7th day of every week upto 30days/daily
2nd to 7th day of every
Week upto 30 days/daily
|Duration
30 days
30 days
|Internally
Triphala Guggul 500mg TID for 30 days.
Triphala Guggul 500mg TID for
30 days.
|Diet
Pathyakar Ahar Vihar
Pathyakar Ahar vihar
Follow up and assessments:
Infiltration will be done on a daily basis. But assessment will be done by 7 days intervals;
viz., on 0,7th14th and 21st and 30th day..
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
- •Patient having sign & symptom of bhagandar with special reference to fistula in ano.
- •All types of Fistula in ano will be taken.
- •Patient Undergoing ksharsutra treatment or done partial Fistulectomy with ksharsutra taken.
排除标准
- •known Cases of Hiv,Hepatitis B,Tuberculosis,Infections,any systemic disease.
- •Known cases of Fistula associaed with Fissure In ano,haemorrhoids,pregnancy,Malignacy.
- •Fistula Connected with other organs like urethra,vagina etc.
结局指标
主要结局
Pain,Discharge,Granulation of the fistula tract,Local tenderness,Healing time
时间窗: 30 days
次要结局
- Pain,Discharge,Granulation of the fistula tract,Local tenderness,Healing time(at every 7th day or last day of every week till 30 days.)