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临床试验/CTRI/2024/05/066898
CTRI/2024/05/066898尚未招募2 期

Effect of Hulba in reducing the size of Uterine Fibroid- A Pilot study

未提供1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年6月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
10
试验地点
1
主要终点
Reduction in size of uterine fibroid on USG pelvis

研究概览

简要总结

Fibroids also known as fibromyomas, myomas or leiomyomas are 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 profound economical burden on healthcare system and it contribute to at least one-third and up to half of all hysterectomies.(4,5) Prevalence of UFs from year 2014 to 2016 was 37.65% in rural south India (Tamil Nadu).(6)Most UFs are usually asymptomatic, while symptomatic patient presents with menstrual irregularity (menorrhagia followed by metrorrhagia or polymenorrhagia), abdominal pain, abdominal mass, urinary frequency, urgency and infertility. Symptoms usually depend on number, size and site of UFs.(3,5) The size of fibroid may range from size of a 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 provide 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 less side effects is required.

In USM, the description of fibroid is mentioned under the heading of “sal’ah” meaning tumor, which usually consider as Waram Balghami.(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, a pilot study is contemplated to evaluate the efficacy of Tukhme Hulba (Trigonella foenum-graecum L./fenugreek seeds) in reducing the size 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

  • Size of uterine fibroid ranging from 1-6cm documented on USG with or without symptoms.

排除标准

  • Pregnancy, Severe symptomatic uterine fibroid and associated endometriosis or adenomyosis.

结局指标

主要结局

Reduction in size of uterine fibroid on USG pelvis

时间窗: At baseline and after 3 months

次要结局

  • Reduction in symptoms(At baseline, 1 month, 2 months & 3 months)

研究者

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

Ismath Shameem

National Institute of Unani Medicine

研究点 (1)

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