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临床试验/NCT07586969
NCT07586969已完成不适用

Modulation of Hyperandrogenic Anovulation Through Fenugreek(Trigonella Foenum Graecum L.) Seeds Among Young Females

University of Lahore1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年9月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
FSH/LH Test

研究概览

简要总结

Hyperandrogenic anovulation is a common gynecological illness that impacts the ovaries, vagina and uterus. According to Statistics, in Pakistan 17.6% of individuals seeking treatment at infertility clinics were found to be affected by hyperandrogenic anovulation. Studies indicate that fenugreek seeds have the potential to improve insulin sensitivity, control hormone levels, namely the increased androgens linked to hyperandrogenic anovulation, and promote ovulation, a process commonly interrupted in individuals with hyperandrogenic anovulation. In order to create a therapy plan that is both affordable and easily accessible for women who suffer from hyperandrogenic anovulation, this study aims to determine the therapeutic efficacy of fenugreek seed powder in reducing symptoms related to the illness. Furthermore, it aims to increase knowledge on the extensive utilization of fenugreek seed powder as a natural treatment for hyperandrogenic anovulation.

详细描述

  • To collect data, written consent was obtained from the hospital and university administration.
  • After receiving signed informed consent, the data were collected.
  1. Screening: The participants who meet the study inclusion criteria were enrolled and FSH/LH, Insulin resistance or lipid profile samples were taken by the hospital lab assistant. The participants will be requested not to alter their routine physical activity.
  2. Allocation: Following screening, participants were divided evenly into three groups: experimental group (1, 2) and one control group. The participants received different dosage in different experimental groups of fenugreek seeds powder) c.Follow up: A systematic communication plan will be developed in order to follow up with participants on their daily consumption of the suggested fenugreek powder through telephonic conversations. For continuous assistance there was a WhatsApp group set up where members may ask issues and get help associated with hyperandrogenic anovulation. The follow up for patients were conducted every month; baseline and after 60 days. Appointments for follow-up exams were made in order to track developments, anthropometric measurements were calculated every follow up and modify the dosage as necessary. The baseline and post study test were compared to test the hypothesis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
15 Years 至 25 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Female have been BMI more than 25
  • Patients with irregular periods or hormonal imbalance
  • Patients with age 15 to 25 years of young females

排除标准

  • Pregnant & Lactating Women
  • Any history of allergic reaction to fenugreek seeds
  • Severe gastrointestinal disorders like crohn's disease
  • People with liver or kidney issue

研究组 & 干预措施

Control group

Active Comparator

• Control group (G0): Participants were only subjected to use Glucophage 500mg 30 minutes before breakfast prescribed by doctor.

干预措施: Control (Drug)

结局指标

主要结局

FSH/LH Test

时间窗: 2 months

Ratio of Follicle Stimulating Hormone (FSH) to Luteinizing Hormone (LH)

次要结局

未报告次要终点

研究者

发起方
University of Lahore
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maria Aslam

Clinical Head University Institute of Diet and Nutritional Sciences

University of Lahore

研究点 (1)

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