Investigating The Efficacy Of Alternate Nostril Breathing (Nadi-Shodhan Paranayam) In Hormonal And Physiological Changes In Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- 1.FSH (Follicle Stimulating Hormone)
研究概览
简要总结
Scientific Title: Investigating the Efficacy of Alternate Nostril Breathing (Nadi-Shodhan Pranayama) in Hormonal and Physiological Changes in Postmenopausal Women: A 12-Week Randomized Controlled Trial
Public Title: Efficacy of Alternate Nostril Breathing (Nadi-Shodhan Pranayama) on Hormonal and Physiological Changes in Postmenopausal Women
Health Condition / Problem Studied: Menopausal and female climacteric states (ICD-10: N95.1)
Study Design: Prospective, randomized controlled trial with block randomization and allocation concealment (SNOSE). Statistician blinded.
Study Population: Postmenopausal women aged 45–70 years.
- Inclusion: Women 45–70 years, postmenopausal, consenting.
- Exclusion: Regular yoga practitioners, history of hormone therapy, uterine surgery, recent surgery (within 3 months), or physical disability.
Sample Size: 128 participants (64 intervention, 64 control).
Setting: Himalayan Institute of Hospital Trust, Swami Rama Himalayan University, Uttarakhand, India.
Intervention:
- Experimental group: 12-week structured yoga program (35 minutes/day, 5 days/week), including Nadi-Shodhan pranayama, selected yoga postures, diaphragmatic breathing, bhramari pranayama, relaxation, and guided meditation.
- Control group: Usual care.
Primary Outcomes:
- Serum Follicle Stimulating Hormone (FSH)
- Serum Luteinizing Hormone (LH)
Secondary Outcomes:
- Vasomotor symptoms (hot flushes, night sweats, palpitations)
- Blood pressure
- Body Mass Index (BMI)
- Menopausal Rating Scale / MENQOL questionnaire
Duration: 12 weeks of intervention with assessments at baseline and 12 weeks.
Analysis Plan: Data entry in Excel; descriptive statistics for categorical and continuous variables. Comparisons using chi-square test, Student’s t-test, paired t-test, and repeated measures ANOVA. Multivariate analysis with logistic regression; Kaplan-Meier and log-rank test for outcome comparisons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Only Post Menopause women will be included
- •Post Menopause women of age group between 45 to 70 Years
- •Who are willing to provide consent.
排除标准
- •Regular practitioner of Yoga
- •Women with physical disabilities
- •Who has had uterus operation
- •Had a history of Menopausal hormone therapy
- •Undergone any surgery in the past 3 months.
结局指标
主要结局
1.FSH (Follicle Stimulating Hormone)
时间窗: 1.Assessment - Baseline | 2. post intervention after 12 weeks
2.LH (Luteinizing Hormone)
时间窗: 1.Assessment - Baseline | 2. post intervention after 12 weeks
次要结局
- 1.Vasomotor Symptoms (Hot Flushes, Night Sweats, Palpitations),(2.Blood Pressure)
研究者
Anushka
Department Of Yoga Sciences Swami Rama Himalayan University