Homeopathic Medication and Nutritional Oriented Diet to Treat Overweight Pregnant Women With Mental Disorder

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Homeopathic Treatment in Pregnant Women With Overweight and Mental Disorder: a Double Blinded Controlled Clinical Trial

Conditions
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Overweight, Pregnancy, Mental Disorder

Intervention / Treatment
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* Drug: Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos
* Drug: Homeopathy and Nutritional oriented diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women with less than 28 weeks, BMI from 26 to 35 Kg/ m2, SRQ-20 positive. Exclusion Criteria: Diabetes 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Nutritional plus Placebo (homeopathy)<br>Nutritional oriented diet for pregnancy period add homeopathic preparation from inert substance. | Drug: Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos<br>* CH 12 preparation, 6 drops, twice a day, 4 days per week, until the end of pregnancy. One medication per appointment.<br>* Other names: Phosphorus;Drug: Homeopathy and Nutritional oriented diet<br>* Homeopathy 6 drops twice a day 4 days per week, active and placebo and Balanced nutritional oriented diet for both groups.<br>|
| Active Comparator: Nutr and Homeop Sulph Puls Lyc Lackt Con Sep Nuxv Calcc Phos<br>Nutrition oriented diet for pregnancy period add active homeopathic medication (Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos) | Drug: Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos<br>* CH 12 preparation, 6 drops, twice a day, 4 days per week, until the end of pregnancy. One medication per appointment.<br>* Other names: Phosphorus;Drug: Homeopathy and Nutritional oriented diet<br>* Homeopathy 6 drops twice a day 4 days per week, active and placebo and Balanced nutritional oriented diet for both groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comorbidities |  | 9 months | 
| Newborn weight |  | 9 months | 
| Pregnancy period |  | 9 months | 
| Collateral effects |  | 9 months | 
| Self perception health |  | 9 months | 
| Apgar score |  | 9 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Homeopathy, overweight, obesity, mental disorder, pregnancy, Overweight pregnant women with suspicious mental disorder