A Comparitive Clinical Study to evaluate the effect of Ghoshaphala Varti and Ghoshaphala Vati in Arshas with Special Reference to Internal Haemorrhoids.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To find out the effect of Ghoshaphala varti and Ghoshaphala vati in Internal Haemorrhoids by observing changes in normalcy of stool consistency
研究概览
简要总结
Arshas1
is a disease afflicting mankind for thousands of years. It presents in the form of mamsa ankuras
(fleshy masses) at the opening of gudamarga (anus) causing obstruction to the pathway. Arshas may be compared with hemorrhoids, which is dilation of hemorrhoidal
plexus of veins situated in the lower portion of the rectum and in the sub epithelial region anal canal3
.
Studies shows 4.4% of total world population is affected by hemorrhoids4
. Incidence rate is 47/1000
majorly in age group of 40-65 years. Males are more affected in comparison to females. The risk factors
are low fiber diet, mixed diet, poor hydration, chronic constipation or diarrhoea, straining during
defecation, low physical activity and obesity5
. Several surgical approaches have been introduced
including hemorrhoidectomy but post operative pain is invariable. In such conditions conservative
methods plays an essential role in preparing the patients for minimally invasive treatments. Bheshaja
chikitsa6
is mentioned as first line of treatment for uncomplicated, recent origin, minimally manifested
arshas . It has major role as it is safe and easy to apply. Bheshaja chikitsa is classified into bahya and
abhyantara . Medicines can be used Externally or internally in various forms. Among them, Varti is effective as stanika chikitsa which is administered per rectally where drugs is released constantly in
guda pradesha.Therefore, this study aims to evaluate the therapeutic effect of Ghoshaphala varti to address the
persistent demand for safer and more efficacious interventions in internal haemorrhoids of Grade I and Grade II.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 16.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with Arshas according to signs and symptoms explained in the classics, i.e., Vistamba (constipation) Srava (Bleeding per anum) toda (Pain) kandu (Pruiritis Ani) • Per rectal, Proctoscopic examination diagnosing Internal Hemorrhoids.
- •• Mucoid discharge per anum.
- •Subjects fulfilling diagnostic criteria who are willing to give informed consent and follow up the protocol of the study.
- •Patients of either gender.
排除标准
- •Patients suffering from systemic diseases like uncontrolled Diabetes mellitus, Tuberculosis, HIV, Hepatitis, bleeding disorders.
- •Patients who are on anticoagulant medications.
- •Pregnant women.
- •Patients having associated ano-rectal diseases like Polyp, Carcinoma rectum, Sentinel tag, Fissure-in-Ano, Fistula-in-Ano.
- •Patients having internal hemorrhoids complications like strangulated, thrombosed, infected internal hemorrhoids.
- •Patients below 16 years and above 70 years of age.
结局指标
主要结局
To find out the effect of Ghoshaphala varti and Ghoshaphala vati in Internal Haemorrhoids by observing changes in normalcy of stool consistency
时间窗: 30 days
and reduction in mucoid discharge,itching,bleeding per rectum
时间窗: 30 days
次要结局
- Haemorrhoids severity score(Bristol stool chart)
研究者
Dr Geetha N S
Sri Dharmasthala Manjunatheshwara College of Ayurveda Hospital and Research Centre, Kuthpady , Udupi