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临床试验/CTRI/2022/01/039573
CTRI/2022/01/039573已完成2/3 期

Evaluation of the change in Quality of Life of Cystocele Patients through Mutramarga Gata Uttarabasti with Shuddha Bala Taila- An Exploratory Study

All India Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年1月2日最近更新:
适应症

试验速览

阶段
2/3 期
状态
已完成
入组人数
20
试验地点
1
主要终点
1.Improvement in the Quality of Life of Cystocele patients through P-QOL Status.

研究概览

简要总结

**BACKGROUND:**Cystocele or prolapsed bladder is a common medical condition in which the urinary bladder herniates through the anterior vaginal wall and bulges in the vagina.It has a high impact on Quality of Life . It adversely affectsthe physiological as well as psychological health of the female and even interferes with their professional life.There are multiple underlying causes for the development of cystocele resulting in weakness of the muscles and the connective tissue surrounding the bladder and vagina or the pelvic floor support system. The main associated risk factors are obesity , increasing age, multiparity , heavylifting, pelvic muscle strain, chronically increased intra-abdominal pressure, collagen abnormality, family history of cystocele, and a history of pelvic surgery. The symptoms of cystocele include feeling of pelvic heaviness , a bulge in the vagina, 6 involuntary escape of urine in moments of stress on the pelvic floor such as hearty laughter, sneezing or coughing, frequency of urination, incomplete emptying of bladder, nocturnal awakening for the purpose of urination more than once or twice a night, urge incontinence and other symptoms of pelvic organ prolapse.

Conservative and surgical measures are available for its management in the contemporary science but they have their own drawbacks. The most commoncomplication of surgery is the recurrence of the prolapse and a need for further repair.Other complications include postoperative bleeding, hematoma, damage to the surrounding pelvic organs, infection of the operative site and dehiscence of the wound, infection of the urinary tract, pain during intercourse, urinary retention, and the formation of a vesicovaginal fistula.Conservative management has its own pitfalls. For example- vaginal pessaries can cause pain, erosion of the vagina, bleeding or infection. And, Kegels exercises have to be performed life-long and it is difficult to do these consistently due to busy schedule.

Due to the above-mentioned drawbacks, there is a clear need to explore and use Ayurvedic treatments given in Samhitas in order to minimize the complications and to provide a permanent cure. Ayurvedic classics have description of Mutramargagata Uttarbasti in Sushruta Samhita with Mutra dosha as well as Bastigata Roga as its indicationMutramargagata Uttarabasti is non-invasive, cost-effective, easily performed and can be done in OPD basis and is expected to give good results in a short time. Moreover, it has no complications or side effects. And Sneha is best for conditions in which Vata is deranged among which also, taila is best Vata shamaka. Moreover, in Shudhh Bala taila , taila is infused with Bala and ksheera and is therefore balya, brimhana and will work best for Apana Vayu Vaigunya.

OBJECTIVES OF THE RESEARCH PROJECT:

PRIMARY:

  1. To assess the effect of Mutramarga gata Uttara Basti with Shudhha Bala taila on the quality of life of Cystocele patients through P-QOL status

  2. To study the effect of Mutramarga gata Uttara Basti with Shudhha Bala taila on the signs and symptoms of Cystocele.

SECONDARY:

  1. To study the changes in the symptoms of cystocele through P-QOL, UDI form-6, IIQ-7, and POPDI-6 scales.

  2. Assessment of the effect on pelvic organ prolapse degree through Pelvic organ prolapse quantification system (POP-Q).

  3. To understand Cystocele and its possible correlation in Ayurveda

METHODOLOGY

TYPE OF STUDY DESIGN Single arm open label exploratory study

STUDY TYPE- Interventional

INTERVENTION: There will be a single group in which Uttara basti will be given through urethral route with Shuddha Bala taila(14) in a dose of 96 ml (1 Prasruta) (15) consecutively for 7 days and the effects would be assessed

FOLLOW-UP:

At Baseline on 0th Day before coming for the Panchakarma Procedure, After Uttara basti on 7th day , After 14 days follow up (rest) period on 22nd day

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

年龄范围
30.00 Year(s) 至 70.00 Year(s)(—)
性别
Female

入选标准

  • •1.Patients having clinical symptoms of cystocele 2.Patients diagnosed with grade I and grade II cystocele with or without urethrocele 3.Patients willing to participate in the study and willing to give written consent.

排除标准

  • •1.Patients with severe systemic disorders 2.Pregnant females 3.Patients having malignancy 4.Patients having third degree uterine prolapse (Procidentia) 5.Known cases of sexually transmitted diseases and acute UTI 6.Uttarabasti Anarha 7.Patients with urethral stricture.

结局指标

主要结局

1.Improvement in the Quality of Life of Cystocele patients through P-QOL Status.

时间窗: 0th Day, 7th Day, 22nd Day

2.Improvement in the clinical Symptoms of Cystocele.

时间窗: 0th Day, 7th Day, 22nd Day

次要结局

  • 1.Reduction in the scores of UDI- 6, IIQ-7, POPDI-6 scales.(2.Improvement in Pelvic Organ Prolapse Quantification grading scale.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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