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临床试验/CTRI/2022/10/046374
CTRI/2022/10/046374尚未招募2/3 期

A Clinical study to evaluate the efficacy of Mochras ksharsutra in the management of Arsha ( IInd & IIIrd degree internal haemorrhoids)

University Post Graduate Institute of Ayurved Studies and Research DSRRAU1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年1月11日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
1 Raktasrava (Bleeding per rectum)

研究概览

简要总结

(Ano-rectal region).Symptoms of Aabhyantara Arsha closely resemble to the clinical features of Internal Haemorrhoids. Arsha is being described by all the classical texts of Ayurveda. Acharya Sushrutaand Vagbhataeven placed this disorder in the “ASHTA MAHAGADAâ€,  (Eight grave diseases). It gives trouble to the person like as an enemy which was explained by Acharyas.

National Center for Health Statistics Johanson and Sonnenberg found that 10 million people in United States complained of Haemorrhoids, Prevalence rate of 4.4 %. In both sexes, a peak inprevalence was noted from age 45–65 yr, with a subsequent decrease after age 65 yr. The development of haemorrhoids before age 20 yr was unusual. A recent prospective study of screening colonoscopy patients revealed the presence of haemorrhoids in 38.9%, with 44.7% of those patients suffering from haemorrhoidal symptoms.

Acharya Sushruta has Arsha (Haemorrhoids) is one of the commonest ailments occurring in Guda Pradesha described four principle therapeutic measures in treating the Arsha. They are Aushadhi (Medicinal), Ksharkarma (Chemical cauterization), Agnikarma (Thermal cauterization) and Shastrakarma (Surgical excision). Sushruta speaks much more about Kshara Karma while going through the chapter for treatment of “Arshaâ€, it becomes quite evident that Kshara Karma has been considered as the most successful, simple and non-invasive para-surgical measure.

Here I am evaluating the efficacy and advantages of Mochras ksharsutra Ligation in  the Management of Arsha (2nd& 3rd degree internal Haemorrhoids).

•           Ayurveda is well known for the treatment of Arsha with Ksharsutra Ligation, due to yielding negligible rate of recurrence, cost effective, lesser pain, no bleeding, no infection, no anal incontinence and requiring minimal hospitalization during treatment with better recovery. Mochras i.e gum of salmalia Malabarica is easily available drug, can keep for longer period ,very safe to use and used to reduces the side effect of kshar karm i.e pain, Bleeding, Prolapse of the pile mass, burning sensation,,discharge ect. while snuhi sheer is difficult to available, can’t keep for longer period, unsafe and many side effects.

Hence to check the quality of MOCHRAS explained by Charak, Sushruta, Bhavprakash ect. Mochras ksharsutra is made for treatment of Arsha (haemorrhoids). Thus present study has been planned.

The aim of the present study is to develop more simplified and ideal therapy with addition of more healing effect and to reduce early & late post operative complication with less discomfort to the patient regarding Bleeding, pain, Prolapse of the pile mass, burning sensation, discharge ect. and Premature sloughing of pile mass. Mochras is safe and easily available drug .Hence  Mochras ksharasutra will be  prepared for ligation

研究设计

研究类型
Interventional
分配方式
Other
盲法
Open Label

入排标准

年龄范围
20.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1 Patient will be selected randomly, irrespective of sex, economical status and education.
  • 2 Patients attended with the classical signs and symptoms of Arsha ( IInd & IIIrd degree internal Haemorrhoids).
  • 3 Patients who will be ready to give written informed consent.

排除标准

  • 1 Patients with other systemic illness like uncontrolled Diabetes mellitus, malignancy etc.
  • 2 HBsAg and Retrovirus positive patients.
  • 3 Secondary internal haemorrhoids because of other systemic disorders.
  • 4 Internal hemorrhoids with other associated Ano-rectal diseases / Colon diseases.
  • 5 Infective and Neoplastic conditions of rectum/Anus.
  • 6 Rectal prolapse, Pelvic pathology and Pregnancy.

结局指标

主要结局

1 Raktasrava (Bleeding per rectum)

时间窗: 1 Raktasrava (Bleeding per rectum) | 2 Prolapse of the pile mass. | 3 Pain (Anal Discomfort) | 4 Mucoid Discharge. | 5 Rate of sloughing of pile mass.

2 Prolapse of the pile mass.

时间窗: 1 Raktasrava (Bleeding per rectum) | 2 Prolapse of the pile mass. | 3 Pain (Anal Discomfort) | 4 Mucoid Discharge. | 5 Rate of sloughing of pile mass.

3 Pain (Anal Discomfort)

时间窗: 1 Raktasrava (Bleeding per rectum) | 2 Prolapse of the pile mass. | 3 Pain (Anal Discomfort) | 4 Mucoid Discharge. | 5 Rate of sloughing of pile mass.

4 Mucoid Discharge.

时间窗: 1 Raktasrava (Bleeding per rectum) | 2 Prolapse of the pile mass. | 3 Pain (Anal Discomfort) | 4 Mucoid Discharge. | 5 Rate of sloughing of pile mass.

5 Rate of sloughing of pile mass.

时间窗: 1 Raktasrava (Bleeding per rectum) | 2 Prolapse of the pile mass. | 3 Pain (Anal Discomfort) | 4 Mucoid Discharge. | 5 Rate of sloughing of pile mass.

次要结局

  • 1 Recovery time.(2 Time to return to work.)

研究者

发起方
University Post Graduate Institute of Ayurved Studies and Research DSRRAU
申办方类型
Research institution and hospital

研究点 (1)

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