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临床试验/CTRI/2025/01/079496
CTRI/2025/01/079496尚未招募2/3 期

Effect of Unani formulations Oral & Topical in uterine fibroid A pre and post analytical study

National institute of Unani medicine1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2025年2月6日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
31
试验地点
1
主要终点
Reduction in uterine fibroid volume on USG pelvis

研究概览

简要总结

Fibroids also known as fibromyomas, myomas or leiomyomas are the most common benign uterine neoplasms, derived from smooth muscle cells and fibroblasts commonly encountered in reproductive age group women.(1,2)Approximately 30%–35% of women are diagnosed with fibroids on ultrasound, but > 70% of the women develop fibroid by the age of 50 years.(2,3)High prevalence of uterine fibroids (UFs) has led to the profound economical burden on the healthcare system and it contributes to at least one-third and up to half of all hysterectomies.(4,5) Prevalence of UFs from the year 2014 to 2016 was 37.65% in rural south India (Tamil Nadu).(6)Most UFs are usually asymptomatic, while symptomatic patients present with menstrual irregularity (menorrhagia followed by metrorrhagia or polymenorrhagia), abdominal pain, abdominal mass, urinary frequency, urgency and infertility. Symptoms usually depend on the number, size, and site of UFs.(3,5) The size of fibroid may range from tiny seedlings to as large as a melon.(6)UFs are associated with impaired fertility and adverse obstetric outcomes.(1)Treatment options for UFs in conventional medicine include analgesics, iron supplements, vitamin D3, COCs, SPRMs, gonadotropin-releasing hormone (GnRH) agonists and antagonist, drugs modulating the estrogen receptors and surgery (hysterectomy, myomectomy, uterine artery embolization (UAE), and focused ultrasound surgery (FUS), both ultrasound and magnetic resonance guided focused ultrasound surgery).(1,7)These treatment are expensive and are associated with lot of side effects and complications.(7) Moreover, such treatment provides temporary relief from symptoms making the hysterectomy as the definitive treatment and rendering the female infertile.(4,7,8) Thus, an alternate approach with cost effectiveness and fewer side effects is required.

In USM, the description of fibroid is mentioned under the heading of “sal’ah” meaning tumor, which usually consider as W**aram Balghami barid.(2,9) Based on the etiology of fibroid, various Unani drugs possessing the properties of anti inflammatory, anti-tumor, antioxidant and antiestrogenic effect are available which may be helpful not only to alleviate the symptoms of uterine fibroid but also to reduce its size.  Hence, present study is contemplated to evaluate the efficacy of oral intake of Munjiz Balgham comprising of Aslussoos,badiyan, badranjboya with Gulqand and local application of zimad of Tukhme- Katan, Hulba, Haloon, with Roughane Bedanjeer(10)in reducing the volume of uterine fibroid.

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 50.00 Year(s)(—)
性别
Female

入选标准

  • Study participants with In age group of 20-50 years with uterine fibroid & Volume of Uterine fibroid more than or equal to 2cm3 to 20cm3 found on USG pelvis HMB PBAC more than 100 Dysmenorrhea VAS more than 5.

排除标准

  • Study participants with Pregnancy Severe symptomatic uterine fibroid PBAC more than 500 and VAS more than 8 Associated Endometriosis Adenomyosis and rapid tumor growth.

结局指标

主要结局

Reduction in uterine fibroid volume on USG pelvis

时间窗: baseline and at 12 weeks

次要结局

  • Improvement in PBAC and VAS score(Improvement in Uterine Fibroid Symptom and Quality of Life Questionnaire (UFS-QOL))

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Qureshi Misbah Mohammed Husain

National institute of unani medicine

研究点 (1)

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