Homeopathy for Overweight and Obesity in Mexican Adolescents

Hospital Juarez de Mexico

Status and phase: Unknown; Phase 2

Conditions: Overweight and Obesity

Treatments: Drug: Homeopathic placebo; Drug: Homeopathic Medication; Other: Multidisciplinary intervention (Exercise program, diet, motivational support)

Study type: Interventional

Funder types: Other

Identifiers

NCT03945396

HJM 0572/19-1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 12 to 19 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Multidisciplinary intervention + homeopathic medication

Experimental group

Description:

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.

Treatment:

Other: Multidisciplinary intervention (Exercise program, diet, motivational support)

Drug: Homeopathic Medication

Multidisciplinary intervention + homeopathic placebo

Active Comparator group

Description:

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.

Treatment:

Other: Multidisciplinary intervention (Exercise program, diet, motivational support)

Drug: Homeopathic placebo