Homeopathic Treatment in Pregnant Women With Overweight and Mental Disorder: a Double Blinded Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Weight
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of homeopathic treatment in pregnant women with overweight and class I obesity with suspicion of a mental disorder.
详细描述
The weight gain during pregnancy has been reported as an important factor of being overweight after delivery and comorbidities. There are a lot of restrictions to treat pregnant women due to fetus development. Homeopathy presents itself as an integrative medicine that could treat with less collateral effects improving general health. The investigators are going to test the effects of homeopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women with less than 28 weeks,
- •BMI from 26 to 35 Kg/ m2,
- •SRQ-20 positive.
排除标准
- •Cardiopathies
- •Hypertension
- •Nephropathies
- •Psychiatric treatment
- •Drug users
- •Pulmonary Chronic Disease
- •Suicidal ideas
- •No eating (appetites)
- •Problems of BMI measurements (disabled people)
- •Concomitant homeopathic treatment
- •People who are looking for just 1 medical appointment
研究组 & 干预措施
Nutritional plus Placebo (homeopathy)
Nutritional oriented diet for pregnancy period add homeopathic preparation from inert substance.
干预措施: Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos (Drug)
Nutritional plus Placebo (homeopathy)
Nutritional oriented diet for pregnancy period add homeopathic preparation from inert substance.
干预措施: Homeopathy and Nutritional oriented diet (Drug)
Nutr and Homeop Sulph Puls Lyc Lackt Con Sep Nuxv Calcc Phos
Nutrition oriented diet for pregnancy period add active homeopathic medication (Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos)
干预措施: Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos (Drug)
Nutr and Homeop Sulph Puls Lyc Lackt Con Sep Nuxv Calcc Phos
Nutrition oriented diet for pregnancy period add active homeopathic medication (Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos)
干预措施: Homeopathy and Nutritional oriented diet (Drug)
结局指标
主要结局
Weight
时间窗: 9 months
次要结局
- Collateral effects(9 months)
- Self perception health(9 months)
- Apgar score(9 month)
- Pregnancy period(9 months)
- Comorbidities(9 months)
- Newborn weight(9 months)
研究者
Edgard Costa de Vilhena
MD, student PhD
University of Sao Paulo