跳至主要内容
临床试验/CTRI/2025/05/087946
CTRI/2025/05/087946尚未招募2/3 期

Integral yoga protocol for managing Premenstrual syndrome: A Randomized controlled trial

University of Patanjali1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月7日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Primary outcomes:

研究概览

简要总结

In modern society, premenstrual syndrome (PMS) has emerged as a prevalent concern among women of reproductive age, often manifesting through emotional instability, fatigue, irritability, and physical discomfort. These symptoms significantly disrupt daily functioning, personal relationships, and professional responsibilities. While healthcare systems aim to promote holistic well-being for women, PMS continues to pose a barrier to optimal mental and physical health. The cumulative impact of PMS on emotional balance, work productivity, and social engagement highlights the urgent need for effective, non-pharmacological interventions. Yoga, widely acknowledged for its integrative benefits on the mind and body, has gained global attention as a therapeutic tool. In India, where yoga is officially supported by the Ministry of AYUSH, it is increasingly incorporated into health interventions for women’s wellness (Khemka et al., 2011). This study investigates the effectiveness of an Integral Yoga Protocol in managing PMS symptoms among women aged 18 to 40 through a randomized controlled trial. By integrating asanas, pranayama, and meditation, the protocol addresses the physical discomfort and emotional fluctuations associated with PMS, aiming to enhance hormonal balance, psychological resilience, and overall quality of life. This research highlights the potential of integral yoga as a holistic, accessible solution for improving women’s reproductive health and well-being.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • The study will include females between the ages of 18 and 40 who experience premenstrual syndrome (PMS).
  • Eligible participants must have a regular menstrual cycle, ensuring the consistency needed to accurately assess the impact of PMS.
  • Additionally, participants must be willing to provide informed consent and actively participate in the study.

排除标准

  • The study will exclude females of reproductive age who have chronic infectious diseases, mental health issues, or any addictive behaviors such as smoking, alcoholism, or drug addiction.
  • Additionally, individuals who have undergone recent surgery or are currently pregnant will not be eligible for participation.
  • Those who express a disinterest in yoga or are already engaged in regular yoga practice, along with those who consistently participate in other forms of exercise, will also be excluded from the study.

结局指标

主要结局

Primary outcomes:

时间窗: At baseline (T0) and at 3 months (T1)

The severity of symptoms of PMS including depression, anxiety and stress measured by DASS questionnaire, (2) fatigue measured by fatigue severity scale, (3) mood swings measured by the brief mood introspection scale, (4) quality of life or well-being measured by the premenstrual syndrome quality of life scale, including alterations in sleep patterns, cramps/pain (including headaches and abdominal, back, and lower back pain).

时间窗: At baseline (T0) and at 3 months (T1)

次要结局

未报告次要终点

研究者

申办方类型
Other [Private University]

研究点 (1)

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