Effect of Cold Hip Bath on Ovarian Morphology among Females with Polycystic Ovarian Syndrome: A Randomized Controlled Trial
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Ovarian Morphology
研究概览
简要总结
PCOS is a common gynecological disorder characterized by irregular menstruation and/or multiple cysts in one or more ovaries associated with high androgen levels in the body. COLD HIP BATH is one of the basic hydrotherapeutic modalities, part of naturopathy, proven to enhance parasympathetic activity and regulate autonomic balance, along with influencing the circadian rhythm regulation and restoring hormonal balance in various gynecological and obstetrical disorders, along with other naturopathic and yoga therapies. No study focused on the individual role of cold hip bath on PCOS well-being; hence, this study is a prospective randomized controlled trial evaluating the effect of cold hip bath on ovarian morphology as the primary outcome and menstrual frequency, hirsutism, BMI and WHR, psychological well-being, and quality of life as the secondary outcomes in 60 females with PCOS for 3 months, with 30 in the intervention group and 30 in the comparison group receiving risk reduction counselling.
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
- 15.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Females diagnosed with PCOS according to Rotterdam Criteria- any two of the three symptoms should be present a. Increased serum concentration of androgens-hyperandrogenemia or the presence of clinical signs related to androgen excess.
- •hyperandrogenism b. Oligoamenorrhoea or anovulation means more than 35 days or less than 8 periods in a year c. Ultrasonography features characteristics of polycystic ovaries- more than 20 ovarian follicles with a 2 to 9 mm diameter in either ovary, or an ovarian volume of more than 10 mL in either ovary or both.
- •Subjects willing to participate in research and ready to sign the informed consent.
- •Subjects willing to take cold hip bath.
排除标准
- •Women with thyroid disorders, hyperprolactinemia, and structural anomalies of the reproductive system.
- •Women who are not willing to consent to the study.
- •Women taking OCDs or on ICDs, insulin-sensitising medications, or any hormonal pills for the past 3 months.
- •Women adhering to a strict exercise, alternative medical treatments or dietary regimen for the past 3 months.
结局指标
主要结局
Ovarian Morphology
时间窗: Baseline and after 90 days excluding menstrual days
次要结局
- Menstrual Frequency(Baseline and after 90 days excluding menstrual days)
- Anthropometric measures BMI and WHR(Baseline and after 90 days excluding menstrual days)
- Hirsutism by The mFG, or modified Ferriman-Gallwey scoring system(Baseline and after 90 days excluding menstrual days)
- Depression Anxiety Stress Scale-21(Baseline & after 90 days excluding menstrual days)
- Polycystic Ovarian Symptom Quesionnaire-Self Administered(Baseline & after 90 days excluding menstrual days)
研究者
RAJESHWARI SWAMINATHAN
Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women