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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00942097
• Other study ID #: HAM-01082009
• Secondary ID: Homeopathy
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 16, 2009
• Last updated: May 8, 2013
• Start date: August 2009
• Est. completion date: December 2012

Study information

• Verified date: May 2013
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Mental Disorder
• Mental Disorders
• Overweight
• Pregnancy
• Psychotic Disorders

Intervention

Drug:
• Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos
CH 12 preparation, 6 drops, twice a day, 4 days per week, until the end of pregnancy. One medication per appointment.
• Homeopathy and Nutritional oriented diet
Homeopathy 6 drops twice a day 4 days per week, active and placebo and Balanced nutritional oriented diet for both groups.

Locations

Country	Name	City	State
Brazil	Amparo Maternal Maternidade Social	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Edgard Costa de Vilhena	Amparo Maternal Maternidade Social

Country where clinical trial is conducted

Brazil, 

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* Note: There are 67 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight		9 months	Yes
Secondary	Comorbidities		9 months	Yes
Secondary	Newborn weight		9 months	Yes
Secondary	Pregnancy period		9 months	Yes
Secondary	Collateral effects		9 months	Yes
Secondary	Self perception health		9 months	Yes
Secondary	Apgar score		9 month	Yes

External Links

•   Groupe International de Recherche sur l'infinitesimal
•   Homeopathé International
•   Homeopathy and fitoteraphy information
•   Homeopathy political informations in Brazil
•   Morpho logica Homeopatica Ruby