跳至主要内容
临床试验/CTRI/2025/02/081183
CTRI/2025/02/081183已完成2 期

Clinical study to evaluate the effect of Nimbadibeeja varti in Haemorrhoids with special reference to Shushka Arshas

未提供1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年3月3日最近更新:

试验速览

阶段
2 期
状态
已完成
入组人数
32
试验地点
1
主要终点
To study the effect of medicine in the symptoms like

研究概览

简要总结

Haemorrhoids are dilated veins in the anal canal in the sub epithelial region formed by the radicles of superior, middle and inferior rectal veins. It is one of  the commonest ailment that afflict mankind. The incidence of this disease is found to be affecting 50% of population at a time and mostly after 50 years, especially men. Owing to unhealthy dietary pattern, low fibre diet , inhibition of natural urges and mental stress coupled with sedentary lifestyle increased the vulnerability to this disease. The common symptoms include mass per rectum, bleeding, itching etc.

Acharyas described different types of haemorrhoids (arsas) based on dosa predominance. One among such classification is Shushka ( non bleeding) and Ardra( bleeding) haemorrhoids. There are different types of internal and external treatment described in classical texts, one among them is varti prayoga. It can be easily administered by the patient himself. The study will be conducted in 32 subjects , irrespective of gender, within the age group of 20 to 70 years, satisfying inclusion and exclusion criteria, selected from the OPD and IPD of Shalyatantra, Pankajakasthuri Ayurveda Medical college and PG centre hospital, Kattakada, Thiruvanandapuram. Symptoms assessed based on assessment criteria.

The varti is prepared from the seeds of nimba, indravaruni and devathali added with jaggery. Varti weighing 3 grams 1 inch length, yavakrithi is prepared. This will be administered per rectally, once daily for 7 days  after  smearing with ghee. The assessment done on before treatment, 8th and 15th day. The data will be analysed using appropriate statistical tests.

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 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Clinically diagnosed cases of first, second and third degree Haemorrhoids.
  • 2.Non bleeding Haemorrhoids 3.Subjects willing to sign informed consent.

排除标准

  • Haemorrhoids associated with malignancy, ulcerative colitis, and rectal prolapse 2.Haemorrhoids that are bleeding, fourth degree, strangulated and thrombosed 3.Subjects diagnosed with systemic illness 4.Pregnanat ladies.

结局指标

主要结局

To study the effect of medicine in the symptoms like

时间窗: Subjective parameters will be assessed at baseline ,4th day, 8th day and 15th day.

1. Degree of protrusion of pile mass

时间窗: Subjective parameters will be assessed at baseline ,4th day, 8th day and 15th day.

2. pruritis ani

时间窗: Subjective parameters will be assessed at baseline ,4th day, 8th day and 15th day.

3. constipation

时间窗: Subjective parameters will be assessed at baseline ,4th day, 8th day and 15th day.

4.mucous discharge

时间窗: Subjective parameters will be assessed at baseline ,4th day, 8th day and 15th day.

次要结局

  • To asses the quality of life after the treatment(Subjective parameters will be assessed on 15th day as follow up)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Suresh Kumar C

Pankajakasthuri Ayurveda Medical college and PG centre Kattakada, Thiruvananthapuram

研究点 (1)

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