Single Centric Non-Randomized Open Clinical Trial Phase II in “Mulai Moolamâ€(Internal Haemorrhoids) with Siddha Medicine “Adathodai Girutham†among patients attending OPD at Government Siddha Medical College Hospital, Chennai.
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
- Primary Outcome will be mainly assessed by reduction in clinical symptoms and by comparing the PNR bleed scale and HSS scale before and after treatment.
研究概览
简要总结
The word ‘Haemorrhoids’ derived from Greek word ‘Haima’(bleed) and
‘Rhoos’(flowing) means bleeding. The word ‘Pile’ derived from Latin word ‘Pila’ means Ball.
Haemorrhoids arise from the congestion of the internal and / or external venous plexus around the anal canal. They are extremely common in adults.
Varicosities of the veins of the anal canal are known as haemorrhoids. It may be internal or external depending on the position of the varicosity. If it is above the Hilton’s Line it is called ’ Internal haemorrhoid’ and if it is below the Hilton’s Line it is called ’External haemorrhoid’. So internal haemorrhoid is covered by mucous membrane whereas the external haemorrhoid is covered with skin.
In India approximately 40,723,288 people are reported to have haemorrhoids. 1million new cases are reported annually, it is estimated that 50-85% 0f people around the world have haemorrhoids and in India 75% of the population is estimated. Current statistics suggest that almost half of people in their fifties have piles.
In classical siddha literature KANNUSAMI PARAMBARAI VAITHIYAM, the siddha medicine formulation ADATHODAI GIRUTHAM is indicated for the MOOLAM. It will be therapeutically effective and it also cost effective and reliable for a long duration treatment. So, the author decides to evaluate its efficacy in an open clinical trial.
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
- 20.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Age 20 to 60 years of both gender 1 degree and 2 degree Internal Haemorrhoids Constipation Pruritis Ani Bleeding per rectum Patients willing to give specimen of blood for the investigation.
排除标准
- •External Haemorrhoids 3 degree and 4 degree Internal Haemorrhoids Fissure in ano Fistula in ano Pregnant and Lactating women Rectal prolapse.
结局指标
主要结局
Primary Outcome will be mainly assessed by reduction in clinical symptoms and by comparing the PNR bleed scale and HSS scale before and after treatment.
时间窗: 3 Months
次要结局
- Secondary Outcome will be mainly assessed by reduction in clinical symptoms and by comparing the PNR bleed scale and HSS scale before and after treatment.(48 Days)
研究者
Bharath R
Government Siddha Medical College, Chennai.
