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临床试验/CTRI/2024/12/078195
CTRI/2024/12/078195尚未招募1/2 期

Role Of Specific Yogic Practices Towards Management Of Primary Dysmenorrhea :A Randomized Control Clinical Trial

km Roopa Sharma1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年12月27日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
130
试验地点
1
主要终点
Significant change in pain intensity and duration, collect samples

研究概览

简要总结

Project Summary: Role of Specific Yogic Practices in Managing Primary DysmenorrheaThis project investigates the efficacy of a structured yoga intervention in alleviating pain and enhancing the quality of life (QOL) for women suffering from primary dysmenorrhea, a prevalent gynecological condition characterized by painful menstruation without underlying pathology. The study also examines the intervention’s effect on biochemical markers such as serum prostaglandin levels.

Study Objectives

  1. Primary Objective: To assess the impact of specific yogic practices on pain relief in primary dysmenorrhea.
  2. Secondary Objectives:
  • To evaluate improvements in QOL using standardized tools (WHOQOL-BREF).
  • To examine changes in menstrual symptoms and serum prostaglandin levels.

Methodology****Design: Randomized controlled clinical trial with 130 participants, split equally into intervention and control groups.Participants: Females aged 14–30 years with primary dysmenorrhea for at least three cycles, experiencing mild to moderate pain.**Interventions:**Trial Group: A tailored yoga protocol including specific asanas, pranayama, and mudras.Control Group: A standardized set of three asanas (Marjaryasana, Bhujangasana, Matsyasana).

  • Duration: 3 months with a 1-month follow-up.
  • Assessment Tools:
  • Visual Analog Scale (VAS) for pain.
  • WHOQOL-BREF for QOL evaluation.
  • Serum prostaglandin measurement using ELISA.

Expected Outcomes

  • Primary: Reduction in pain intensity and duration.
  • Secondary:
  • Decreased prostaglandin levels.
  • Improvement in associated symptoms (e.g., nausea, fatigue).
  • Enhanced QOL metrics.

SignificanceThe project addresses a critical gap in non-pharmacological interventions for managing menstrual pain. By exploring yoga’s therapeutic potential, it aims to offer a cost-effective, accessible, and holistic alternative to conventional treatments for primary dysmenorrhea.

Ethical Considerations

  • Approved by the Institutional Ethics Committee.
  • Informed consent from all participants.
  • Confidentiality maintained through anonymized data.

This study is expected to generate evidence supporting yoga as an effective complementary treatment for dysmenorrhea, contributing to the broader acceptance of traditional practices in modern medicine.

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

入选标准

  • 1.Individuals between the age group of 14 -30 years.
  • 2.Patients come with chief complaint of pain with irregular menses.
  • 3.Patients having scanty or average amount of menses along with associated symptoms: 4.Patients suffering from Dysmenorrhea for more than 3 consecutive cycles.
  • 5.Individuals willing to take part in the study.

排除标准

  • 1.Patients suffering from systemic chronic illness.
  • 2.Those diagnosed with Secondary Dysmenorrhea 3.Patients who marked severe pain in VAS scale.

结局指标

主要结局

Significant change in pain intensity and duration, collect samples

时间窗: 12 weeks

次要结局

  • 1.Significant change in Menstruation related symptoms(2.Serum Prostaglandin)

研究者

发起方
km Roopa Sharma
申办方类型
Other [UGC NET JRF (JUNIOUR RESEARCH FELLOWSHIP)]
责任方
Principal Investigator
主要研究者

Km Roopa Sharma

Amity University sector 125 , Noida

研究点 (1)

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