CTRI/2024/05/066948Other (Terminated)3 期
A randomized, Single center, Single-blind, Parallel, Two-Arm, Comparative analysis of composite lifestyle intervention and conventional methods in managing obese PCOS related hormonal and metabolic parameters in subjects with PCOS.
DrSakthivel1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年5月21日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- Other (Terminated)
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The primary outcome of the study will recruit the 120 subjects to assess the PCOS hormonal parameters at 24 weeks
研究概览
简要总结
STUDY DRUG: Conventional Method: Any Oral PCOS drugs Interventional Method: Lifestyle Modification (Diet, Yoga, Exercise and Sleep) The innovator and/or inventional method may contain Diet (proper diet chart which is given by dietician), Yoga and exercise and sleep pattern In the conventional method, the participant will take any Oral PCOS drugs to treat their PCOS with regular food chart with regular activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
入选标准
- •ï‚·Age Range: Participants aged 20 to 40 years (inclusive).
- •Subject must meet age requirements at the time of signing the initial study specific informed consent.
- •In addition, the subject’s race and ethnicity should be documented.
- •ï‚·Gender: Females, Non-Pregnant or Non-lactating Female and Child bearing potential women ï‚·Women of Child bearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days prior to the randomization.
- •ï‚·Women of child barring potential are to be subjected to contraceptive techniques to refrain from pregnancy via oral, hormonal, or other contraceptive methods.
- •ï‚·Diagnosis of PCOS: Participants must have a confirmed diagnosis of PCOS based on established criteria (e.g., Rotterdam criteria).
- •Hypothyroid adequately replaced.
- •ï‚·Controlled Diabetic, Pre diabetes and non diabetic females are considered for the study (hbA1c≤8) ï‚·Body Mass Index (BMI):Each subject should have a Body mass index (BMI)value less than or equal to 35.0kg/m2 but greater than 23.0kg/m
- •All weight values are to be reported according to the scale’s precision (I.e. the nearest tenth or hundredth 72.3 kg or 72.25kg).
- •The subject’s height is to be reported in centimeters near to tenth.
- •Each subject’s BMI is to be calculated using the reported weight in kilograms and height in centimeters and it is should be reported to the nearest tenth (I.e. 26.3kg/m2) ï‚·Sleep routine: sleep cycle should be at least 5 to 8 hours/ day.
- •ï‚·Smoking status: The subject should be non-smokers, non-alcoholic or not using any smoking or alcohol or any tobacco related products for more than a year.
- •ï‚·Willingness to Participate: Individuals willing to follow the protocol requirements and comply with protocol restrictions.
- •ï‚·Consent: Participants should have adequate decision-making ability to make a choice about participating in this study and provide written informed consent to participate.
- •ï‚·All the candidates are to be examined by the chief medical practitioner and other parameters corresponding to the clinical diagnosis are evaluated.
- •ï‚·If warranted other tests or examinations can be done at the discrepancy of the investigator.
排除标准
- •ï‚·Age: Adult women in the age group of 20 to 40 who pregnant.
- •ï‚·Pregnancy and Lactation: ï‚·Participants who are currently pregnant or planning to become pregnant during the study period.
- •ï‚·Participants who are currently lactating.
- •ï‚·B- HCG positive within 15 days of start of study or prestudy medical examination are to be excluded Menopausal Status: Women in menopause.
结局指标
主要结局
The primary outcome of the study will recruit the 120 subjects to assess the PCOS hormonal parameters at 24 weeks
时间窗: This study was undertaken to explore the influence and thyroid function, insulin resistance, body weight, BMI, and lipid profile as secondary outcomes.
次要结局
- This study was undertaken to explore the influence & enhancement of thyroid function, insulin resistance, body weight, BMI, & lipid profile as secondary outcomes at 12 weeks(The assessment of improvements in inflammatory response, sleep patterns, subjective well-being scores, skin, & hair conditions (specifically hirsutism), & parameters associated with menstruation such as stomach pain, abdominal bloating, & period cramps were considered as secondary measures.)
研究者
Dr Sakthivel
Hormone Clinic
研究点 (1)
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