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临床试验/CTRI/2025/04/085404
CTRI/2025/04/085404尚未招募2 期

Effect of Varahaadi Vasa Yoni Pichu Dharana in Pelvic Organ Prolapse

Anjaly Biju1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2025年5月3日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
26
试验地点
1
主要终点
To assess the change of anterior, posterior and middle compartment pelvic organ

研究概览

简要总结

Pelvic organ prolapse (POP) is a bulge or protrusion of pelvic organs and their associated vaginal segments into or through vagina. It is a common condition leading to genital tract dysfunction and diminishes the quality of life with a prevalence of 3% to 50%. Prolapse occurs due to the weakness of supporting structures and suspension mechanism of uterus and vaginal wall. POP is multifactorial even though evident in women with a greater number of vaginal deliveries, instrumental delivery, medical conditions like chronic cough, constipation. Symptoms include feeling of something coming down per vagina, dragging pain in pelvis, dyspareunia, urinary symptoms and bowel symptoms like incomplete evacuation. Both nonsurgical and surgical management can be selected appropriately depending on the extent of descend. Displacement or prolapse of genital organs are explained by Acharyas as Andini,Phalini, Prasramsini,Mahayoni yonivyapat.Vatika yonivyapat chikitsa along with sthanika chikitsa is beneficial in yonivyapat.Yonipichu dharana one among the sthanika procedure can be effectively utilised for the management of pelvic organ prolapse. The study aims to determine the effect of Varahaadi vasa yoni pichu dharana in POP mentioned in the Kuchumaratantrabhashyam. This is an interventional pre and post study with sample size 26. Subjects aged 40 – 75 years attending Prasutitantra and Streeroga OPD and IPD of Government Ayurveda college, Tripunithura diagnosed with Pelvic Organ Prolapse following inclusion and exclusion criteria will be taken for study. Data collection will be done by clinical observation through case proforma and relevant investigations will be done and staging will be done according to POP Q scale. Yonipichu made of Varahaadi vasa will be kept in vaginal canal till the urge of micturition. Treatment procedure will be done alternatively for 15 days in a 1 month and follow-up after 1 month. Assessment will be done on 0th day,31st day and 61st day. Change in Prolapse will be assessed using POP-Q scale, perineometer. Associated symptoms are assessed using VAS scale and Urinary Incontinence scale. Results will be statistically analysed and summarised to arrive the conclusion.

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
40.00 Year(s) 至 75.00 Year(s)(—)
性别
Female

入选标准

  • Patients presenting with POP including cystocele, rectocele, urethrocele, first degree, second degree and third degree uterine prolapse Participants who is willing and competent to give consent Participants willing to take medicines prepared from animal source swine,hen.

排除标准

  • Females with 4th degree uterine prolapse Decubitus ulcer Known case of Genital malignancy Infectious disorders of genital tract like HIV, Hepatitis B, Syphilis Congenital anomalies leading to prolapse G) Pelvic Inflammatory diseases H) Known case of food allergy(pig,hen).

结局指标

主要结局

To assess the change of anterior, posterior and middle compartment pelvic organ

时间窗: Alternatively for 15 days in a month

prolapse using POP-Q scale

时间窗: Alternatively for 15 days in a month

次要结局

  • Pelvic floor strength before and after treatment using perineometer(Low back ache assessed by visual analogue scale)

研究者

发起方
Anjaly Biju
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Anjaly Biju

Government Ayurveda College Tripunithura

研究点 (1)

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