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

Phase 2

Completed

• Conditions: Overweight; Pregnancy; Mental Disorder
• Interventions: Drug: Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos; Drug: Homeopathy and Nutritional oriented diet

• Registration Number: NCT00942097
• Lead Sponsor: Edgard Costa de Vilhena

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2009-07-16
• Study First Submitted QC: 2009-07-17
• Study First Posted: 2009-07-20
• Study Start: 2009-08
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-08
• Last Update Posted: 2013-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 134

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutritional plus Placebo (homeopathy)	Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos	Nutritional oriented diet for pregnancy period add homeopathic preparation from inert substance.
Nutritional plus Placebo (homeopathy)	Homeopathy and Nutritional oriented diet	Nutritional oriented diet for pregnancy period add homeopathic preparation from inert substance.
Nutr and Homeop Sulph Puls Lyc Lackt Con Sep Nuxv Calcc Phos	Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos	Nutrition oriented diet for pregnancy period add active homeopathic medication (Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos)
Nutr and Homeop Sulph Puls Lyc Lackt Con Sep Nuxv Calcc Phos	Homeopathy and Nutritional oriented diet	Nutrition oriented diet for pregnancy period add active homeopathic medication (Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos)

Primary Outcome Measures

Name	Time	Method
Weight	9 months

Secondary Outcome Measures

Name	Time	Method
Collateral effects	9 months
Self perception health	9 months
Apgar score	9 month
Pregnancy period	9 months
Comorbidities	9 months
Newborn weight	9 months

Trial Locations

Locations (1)

Amparo Maternal Maternidade Social; 🇧🇷 São Paulo, Brazil