CTRI/2023/03/050372尚未招募2 期
Randomized controlled clinical trial to study efficacy of Yashtimadhu Krushntil Kalka Siddha Tail Matrabasti in the treatment of Parikartika (Acute Fissure in ano)
Dr. Jyoti Balaso Godase1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年3月20日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Complete healing of fissure
研究概览
简要总结
This study is prospective, randomized, open labelled, controlled clinical study of use of Yashtimadhu Krushntil Kalk Siddha Tail Matrabasti in the dose of 60ml per day for 7 days along with sits bath- lukewarm water twice a day after defecation with laxative- Gandharva Haritaki 3gm orally at bed time for 21 days with assessment and follow up on 0th, 8th, 14th and 22nd day in the treatment of Parikartika ( Acute Fissure in ano). This study is conducted as PG course at single center. The primary outcome is to study efficacy of Yashtimadhu Krushntil Kalk Siddha tail Matrabasti in the treatment of Parikartika (Acute Fissure in ano)
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients clinically diagnosed / confirmed by Inspections as having Parikartika (fissure in-ano) 2) Patient age group between 18-60 years.
- •Patients willing to give consent and able to participate in the study for 28 days.
- •Patients irrespective of gender, religion, their caste, marital status and economic class will be included.
排除标准
- •Patients who are contraindicated for basti (basti-anarha).
- •Patients having Parikartika (Fissure in-Ano) secondary to any other disease will be excluded.
- •Patients with uncontrolled systemic disease as like diabetes and Hypertension will be excluded.
- •Patients with infectious diseases like HIV and Hepatitis and syphilis will be excluded.
- •Patients with other co-existing anal pathologies like haemorrhoid, fistula in-ano, prolapsed rectum, rectal polyp, Ca rectum, will be excluded.
- •Patients having any other sever systemic disorders will be excluded.
结局指标
主要结局
Complete healing of fissure
时间窗: 22 days
次要结局
- 1. Complete healing of fissure 2.Decreased pain during defecation(3. Decreased PR bleeding)
研究者
研究点 (1)
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