Efficacy of a Multidisciplinary Intervention and Homeopahy for Overweight or Obesity in Mexican Adolescents: a Study Protocol for a Randomized Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline in mean total weight in kilograms (kg)
研究概览
简要总结
This study evaluates the efficacy of a multidisciplinary intervention (diet, exercise, motivational support and homeopathy or placebo) for overweight and obesity in Mexican adolescents. Half of study participants will receive the multidisciplinary intervention plus Calcarea carbonica ostrearum, a homeopathic medicine, while the other half will receive the same multidisciplinary intervention plus placebo.
详细描述
Overweight and obesity in children and adolescents are a major public health issue in Mexico. Whilst many factors (genetic, cultural, socioeconomic and environmental) contribute to develop obesity during childhood, a multidisciplinary intervention (nutritional, behavioral and exercise) is the best approach to improve weight loss. In Mexico, the use of homeopathy for obesity is widespread. Although there are some homeopathic medicines used for obese individuals, there is a lack of well-designed clinical trials to demonstrate its efficacy in weight loss. Calcarea carbonica ostrearum is a homeopathic mineral medicine. Previously, it has been demonstrated that Calcarea carbonica has an effect in reducing the percentage of fat in adolescents.
Therefore, a randomized, placebo-controlled, double-blind, parallel, superiority trial with a 3 month study duration, will be conducted to prove the efficacy and safety of Calcarea carbonica ostrearum in reducing weight, body mass index (BMI) and fat percentage, as well as, to prove its effect on the lipid profile, fasting serum glucose, glycosylated hemoglobin and insulin.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 12 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12 to 19 years old.
- •At least elementary school.
- •Overweight (BMI ≥ 85th but <95th percentile based on the Centers for Disease Control and Prevention growth chart) or obese (BMI ≥95th percentile).
- •Fasting serum glucose <126 mg/dl.
- •Glycosylated hemoglobin <6.5%.
- •With symptoms that match with Calcarea carbonica ostrearum.
- •Willingness to participate, and verbal and written consent.
排除标准
- •Pregnancy or breastfeeding.
- •Cases already undergoing treatment (homeopathic, nutritional or structured physical activity) for obesity within last three months.
- •Currently use of metformin, orlistat, insulin, other antidiabetic medication, contraceptive pills, medications with effects on lipid metabolism [thiazide and loop diuretics, β and α receptor blockers, antiepileptic drugs (carbamazepine, phenytoin, valproic acid, phenobarbital), antipsychotics (clozapine), protease inhibitors (amprenavir, indinavir, nelfinavir, ritonavir, saquinavir), tamoxifen, raloxifene, isotretinoin, acitretin, ciclosporin, azathioprine, sirolimus].
- •Any condition that prevents physical exercise.
- •Diabetes, hypertension, thyroid diseases, Down syndrome, mental retardation.
研究组 & 干预措施
Multidisciplinary intervention + homeopathic medication
Multidisciplinary intervention (diet, exercise program, motivational support) and Calcarea carbonica ostrearum 30c.
A single dose of Calcarea carbonica ostrearum 30C dissolved in a 30 ml bottle of 30% alcohol-distilled water. Patients will receive 8 drops PO three times per day prior agitation.
干预措施: Homeopathic Medication (Drug)
Multidisciplinary intervention + homeopathic medication
Multidisciplinary intervention (diet, exercise program, motivational support) and Calcarea carbonica ostrearum 30c.
A single dose of Calcarea carbonica ostrearum 30C dissolved in a 30 ml bottle of 30% alcohol-distilled water. Patients will receive 8 drops PO three times per day prior agitation.
干预措施: Multidisciplinary intervention (Exercise program, diet, motivational support) (Other)
Multidisciplinary intervention + homeopathic placebo
Multidisciplinary intervention (diet, exercise program, motivational support) and placebo.
Placebo will be prepared with 30% alcohol-distilled water only, in the same 30 ml bottle. Patients will receive 8 drops PO three times per day prior agitation.
干预措施: Multidisciplinary intervention (Exercise program, diet, motivational support) (Other)
Multidisciplinary intervention + homeopathic placebo
Multidisciplinary intervention (diet, exercise program, motivational support) and placebo.
Placebo will be prepared with 30% alcohol-distilled water only, in the same 30 ml bottle. Patients will receive 8 drops PO three times per day prior agitation.
干预措施: Homeopathic placebo (Drug)
结局指标
主要结局
Change from baseline in mean total weight in kilograms (kg)
时间窗: At baseline and week 4, 8 and 12.
Weight measured with the participants barefooted and lightly dressed, with a Tanita scale Fitscan BC-545 F segmental body composition monitor. The scale has an eight electrode body composition monitor that displays twenty readings; ten whole body and ten segmental (arms, legs and trunk area).
Change from baseline in percentage of body fat
时间窗: At baseline and week 4, 8 and 12.
Body fat measured with Tanita scale Fitscan BC-545 F segmental body composition monitor. Values greater than 30% for females, and 25% for males, are considered high and of risk
次要结局
- Change from baseline in mean total lean body mass (kg).(At baseline and week 4, 8 and 12.)
- Change from baseline waist-hip ratio.(At baseline and week 4, 8 and 12.)
- Change from baseline in mean total body mass index (BMI).(At baseline and week 4, 8 and 12.)
- Change from baseline in mean total fat mass index(At baseline and week 4, 8 and 12.)
- Change from baseline in mean total lean muscle mass (kg).(At baseline and week 4, 8 and 12.)
- Number and severity of all adverse events(After participants consent and enrolled in the study and 15 days after study completion.)
研究者
Emma del Carmen Macías-Cortés, MD, PhD
Head of homeopathy outpatient service
Hospital Juarez de Mexico