Comparative evaluation on efficacy of Habb-e-Rasuat vs Habb-e-Muqil in bawaseer ghaira (Internal Haemorrhoids) – An open label Randomized clinical trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction in mass and bleeding per rectum
研究概览
简要总结
As per Unani literature haemorrhoid is known as “Bawaseerâ€. Bawaseer is pleural of basoor which means warts or polyp like swelling. It is an excessive growth at the mouth of vessels present in anus which forms due to ghaleez khilt-e-sauda.11 According to Majoosi, Bawaseer is an excessive growth at mouth of vessels present in anus.12 Whereas Ibn Hubal Baghdadi described that the formation of Bawaseer indicates that the morbid viscid humour (ghaleez akhalat) is present in the body.
The basic principle of management of haemorrhoids is Izale-sabab (elimination of cause) that means avoid the food (diet) which forms khilt-e-sauda in body, Tanqiya-e-ma‘dda (evacuation of morbid matter) through venesection, cupping and laxatives. Other methods which can be used for the treatment of haemorrhoids include correction of liver, intestine, stomach and spleen because haemorrhoids can never form without Su-e-mizaj of these organs.In Unani system of medicine the drugs used in the treatment of haemorrhoids should have following properties like Habis-ud-dam (Haemostatic), Mullayin (Laxative), Muhallille Warm (Anti Inflamatory), Mujaffif (Desiccative), Mudammil (Healing property), and Musakkin-e-alam (Analgesic).
Based on the above principle above mentioned intervention is being evaluated for its efficacy in the management of internal haemorrhoids.
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
- •1.Diagnosed case of internal haemorrhoids grade I and II
- •Patients who have agreed to sign the informed consent form and follow up the protocol.
排除标准
- •1.External pile mass
- •Severe systemic illness including IBD, Liver cirrhosis, portal hypertension.
- •Pregnant and lactating women.
- •4.Haemorrhoids associated with other Anorectal diseases like rectal polyp, Fissure in Ano, Fistula in Ano, Carcinoma of Rectum and Anal canal, STD’s.
结局指标
主要结局
Reduction in mass and bleeding per rectum
时间窗: 28 days
次要结局
- Per rectal Mucus discharge(Perianal Itching)
