跳至主要内容
临床试验/CTRI/2022/11/047041
CTRI/2022/11/047041已完成3 期

"Effect of Arogya Raksha Panchatantra (five lifestyle principles) on Heart rate variability, Health related quality of life, performance and self-efficacy in Young female adults with primary dysmenorrhea. A Randomizedcontrol trial, Version 1.0"

Sant Hirdaram Medical College of Natupropathy and Yogic Sciences1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2022年10月11日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
To study the effects of Arogya Raksha

研究概览

简要总结

Primary dysmenorrhea (PD) is one of the most prevalent gynecologic conditions, affecting approximately70% of adolescent and adult females.It is associated with various physical and psychological symptoms such as headache, lethargy, sleep disturbances, tender breasts, various body pains, disturbed appetite, nausea, vomiting, constipation, anxiety, depression, and irritability. Unlike secondary dysmenorrhea which is characterized by having some distinct pelvic pathology leading to pain, primary dysmenorrhea is associated with intrauterine secretion of prostaglandins F2α and E2 leading to uterine contractions and pain.PD is associated with lower quality of life and is one of the most common causes of poor school and work attendance and performance accounting for the loss of approximately 600 million work hours and over $2 billion annually. Conventional management of PD comprises NSAIDS and hormonal treatments which may not be viable treatments for all females because of contraindications and potential side effects, such as nausea, vomiting, GI bleeding, acne, and asthma especially when used for long.This necessitates a long-term and effective intervention which helps in the improvement of Quality-of-Life for women suffering from PD.Arogya rakshak Panchatantrs also called swastha rakshak Panchatantra are the five basic lifestyle principles of health preservation advocated by an Indian Naturopath Dr. V. Venkat Rao which are as follows .·    Eat twice a day ·    Drink at least 2 seers (8-10) glasses of water in a day·    Exercise daily for 1 hour·    Fasting once in a week ·    Prayers twice a day  Heart rate variability (HRV) is the variation in the duration between two adjacent heartbeats. Our mental attitude, emotions, stress, relaxation, and sleep influence the autonomic nervous system which comprises the sympathetic and parasympathetic nervous systems thereby influencing variability in heartbeats. Higher HRV is associated with attenuated resilience, self-regulatory capacity, emotional processing, performance, wellbeing, and lesser inflammation. The Time-domain and frequency-domain analysis of HRV is used widely as a biological marker of homeostatic status. Inflammation in our body is controlled by the autonomic nervous system. Excessive as well as poor inflammation is associated with a wide range of diseases. HRV assessment is a non-invasive technique that may help in the prognosis of inflammation levels in the body.Literature suggests that dysmenorrhea is associated with low heart rate variability. In such cases therapeutic interventions that target autonomic balance or improving HRV may be beneficial to patients suffering from PD. Evidence also  shows that dysmenorrhoea is highly associated with stress, sedentary and unhealthy lifestyles in medical students.Evidences also shows that lifestyle interventions like good nutrition, yoga, exercises, and heat therapies are effective in improving dysmenorrhea-related outcomes.12However sustainability and adherence to such interventions among young females are not well documented. Therefore, this study intends to understand the long-term effect of Arogya rakshak Panchatantra as a sustainable intervention in reducing inflammation, restoring homeostasis, and thereby enhancing the quality of life in dysmenorrheic college girls.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
16.00 Year(s) 至 25.00 Year(s)(—)
性别
Female

入选标准

  • Regular menstrual cycle with cycle duration between 25-40 days Vas score for pain >3 (at the time of screening) No medical history of any gynecological diseases Not taking any hormonal treatments Nullipara •Normal BMI (18-25) •Those willing to give informed consent.

排除标准

  • Participants with any known history of any systemic pathology Menorrhagia Habitual smoking, addiction Those taking OCPs or any hormonal medications BMI >25 and < 18.

结局指标

主要结局

To study the effects of Arogya Raksha

时间窗: Heart rate variability will be taken at baseline( 0 weeks ) , then 4 weeks, 8 weeks , 12 weeks and after 6 months

Panchatantra (basic five lifestyle principles)

时间窗: Heart rate variability will be taken at baseline( 0 weeks ) , then 4 weeks, 8 weeks , 12 weeks and after 6 months

on autonomic flexibility using Heart rate

时间窗: Heart rate variability will be taken at baseline( 0 weeks ) , then 4 weeks, 8 weeks , 12 weeks and after 6 months

variability (HRV).

时间窗: Heart rate variability will be taken at baseline( 0 weeks ) , then 4 weeks, 8 weeks , 12 weeks and after 6 months

次要结局

  • To study the long-term association between dysmenorrhea and HRV(To study the impact of Arogya Raksha Panchatantra on primary dysmenorrhoea symptoms using a retrospective symptom scale (RSS).)

研究者

发起方
Sant Hirdaram Medical College of Natupropathy and Yogic Sciences
申办方类型
Private medical college

研究点 (1)

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