跳至主要内容
临床试验/CTRI/2025/07/090997
CTRI/2025/07/090997尚未招募2/3 期

Development, Validation and Evaluation of comparative efficacy of Community Based Nurse Led Life Style Modification (LSM) Protocol versus conventional care on thyroid dysfunction and menstrual irregularities among adolescent’s girls

Datta Meghe Institute of Higher Education and Research2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年9月22日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
50
试验地点
2
主要终点
Early of improvement in menstrual cycle in adolescent girls

研究概览

简要总结

Menstrual irregularities are common problem among adolescent girls  in the reproductive age and pose a huge burden on gynecology OPD, accounting for approximately 20% of attendance. These causes significant social embarrassment, affects quality of life and productivity, imposes financial burden and also leads to surgical interventions like curettage. In India, thyroid disorders are among the most common endocrine diseases. According to the National Family Health Survey (2019-21) under the parameters of goiter or thyroid disorders the prevalence  is 2.7% for women out of which 0.7 %  is the 15-19 years adolescents age group. Thyroid hormones have important role in normal reproductive physiology both by directly effecting the ovaries and indirectly by interacting with sex hormone-binding globulin. Thyroid disorders are commoner in women than in men and leads to abnormal sexual development, menstrual disorders, infertility and premature menopause.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
15.00 Year(s) 至 19.00 Year(s)(—)
性别
Female

入选标准

  • Those adolescent girls between the ages of fifteen to nineteen Those who are willing to participate in the study Those who have mild and moderate levels of hypothyroidism Those who have hypothyroidism with anemia obesity PCOS.

排除标准

  • 1.Those who have severe levels of thyroid 2.Those who are married and pregnant or breastfeeding.
  • 3.Those taking dietary supplements like selenium or iodine.
  • 4.Those who are adolescent girls taking all of the drug classes of antidepressants, and steroids, suffering from Diabetes Mellitus, chronic and acute renal failure, and stroke, those who are suffering from asthma and sinus problems, and those who have a cold and cough.

结局指标

主要结局

Early of improvement in menstrual cycle in adolescent girls

时间窗: Assessment will be done at three month and six month

次要结局

  • Change in knowledge of health professional regarding Community Based Nurse Led Life Style Modification (LSM) Protocol

研究者

发起方
Datta Meghe Institute of Higher Education and Research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Manjusha Mahakarkar

Datta Meghe Institute of Higher Education and Research Deemed to be University

研究点 (2)

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