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临床试验/CTRI/2025/02/080031
CTRI/2025/02/080031尚未招募不适用

A Comparative clinical study to evaluate the add on Effectiveness of Methika Granules in Primary Dysmenorrhea

SDM College of Ayurveda and Hospital BM Road Thanniruhalla Hassan Karnataka India1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Reduction in pain

研究概览

简要总结

Acharya**Kashyapa explored the medicinal potential of Aahar (food) along with its prophylactic value in maintaining health. He stated that food is the best medicine, and no drug can match the benefits of food in a diseased state. Only wholesome food can keep a person healthy.1 Methika(Trigonella foenum graecum) is one of the oldest known medicinal plants2 which is commonly used as condiment in many food preperations3. It is not only used for enhancing the taste of food, but also provides some preventive health benefits. It has been associated with reduced severity of dysmenorrhea including menstrual pain, fatigue, nausea, headache and lack of energy.2 Phytoestrogens are plant-based compounds4 which aids in hormonal production5. Diosgenin and trigonellin are the primary chemical constituents of Methika considered as phytoestrogen causes variation in the release of estrogen and progesterone leading to regulated uterine contractions and controlled release of prostaglandins and thereby pain. This shows the Antispasmodic and Spasmolytic activity of Methika. The ability of Methika to prevent platelet aggregation causes liquefaction of menstrual blood clots avoids excessive muscular contractions which is another cause of dysmenorrhea.5

Primary dysmenorrhea is a condition which causes painful menstrual cramps without pelvic pathology.6In India the estimated prevalence of primary dysmenorrhea reported in 2023 is 85.28%7. In various studies adolescents with primary dysmenorrhea report that it affects their academic performance, social and sports activities8. In severe cases it results in absenteeism from work or School6 and is a common cause of reduced quality of life in women.9 The most common issue of menstrual problems on daily routine were reported by students and unmarried women, with prolonged resting hours followed by inability to study.8 In fact, it is estimated that each year due to dysmenorrhea, over 600 million working hours are lost. Such absences lessen the opportunities for successful educational, psychosocial and cognitive development during adolescent growth.8 Lifestyle plays an important role in maintenance of health9. Faulty lifestyle adoptions such as- stress, not being physically active, eating and sleeping at irregular intervals etc are all the factors contributing to increased prevalence of the condition.9 In present era, as dysmenorrhea is a burning problem and population of dysmenorrheal women is increasing day by day, there is a need to solve this problem. Methika being cost effective, readily available in households and its capacity to retain its properties in dry form, it will be formulated in the form of granules to make it as palatable, easy for consumption and its add-on effectiveness in management of primary dysmenorrhea will be assessed.

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
18.00 Year(s) 至 30.00 Year(s)(—)
性别
Female

入选标准

  • Subjects between the age group of 18-30years
  • Subjects having regular menstrual cycles
  • Subjects who are willing to give consent for the study.

排除标准

  • 1.Acyclic bleeding
  • Any pelvic pathology leading to dysmenorrhea
  • K/C/O Diabetes Mellitus.

结局指标

主要结局

Reduction in pain

时间窗: 1st, 2nd and 3rd day

ful periods and improving the lifestyle of individuals.

时间窗: 1st, 2nd and 3rd day

次要结局

  • Reduction in School and office absenteeism(1st, 2nd and 3rd day)

研究者

发起方
SDM College of Ayurveda and Hospital BM Road Thanniruhalla Hassan Karnataka India
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Hridya S

Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan College of Ayurveda Hassan

研究点 (1)

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