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

This study has been completed.
Sponsor:
Collaborator:
Amparo Maternal Maternidade Social (USaoPaulo)
Information provided by (Responsible Party):
Edgard Costa de Vilhena, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00942097
First received: July 16, 2009
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Overweight
Pregnancy
Mental Disorder
Drug: Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos
Drug: Homeopathy and Nutritional oriented diet
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Homeopathic Treatment in Pregnant Women With Overweight and Mental Disorder: a Double Blinded Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Weight [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Comorbidities [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Newborn weight [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Pregnancy period [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Collateral effects [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Self perception health [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Apgar score [ Time Frame: 9 month ] [ Designated as safety issue: Yes ]

Enrollment: 134
Study Start Date: August 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Nutritional plus Placebo (homeopathy)
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
CH 12 preparation, 6 drops, twice a day, 4 days per week, until the end of pregnancy. One medication per appointment.
Other Names:
  • Sulphur
  • Puls
  • Lyc
  • Lack-t
  • Conium-m
  • Nux-v
  • Calc-c
  • Sep
  • Phosphorus
Drug: 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.
Active Comparator: Nutr and Homeop Sulph Puls Lyc Lackt Con Sep Nuxv Calcc Phos
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
CH 12 preparation, 6 drops, twice a day, 4 days per week, until the end of pregnancy. One medication per appointment.
Other Names:
  • Sulphur
  • Puls
  • Lyc
  • Lack-t
  • Conium-m
  • Nux-v
  • Calc-c
  • Sep
  • Phosphorus
Drug: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00942097

Locations
Brazil
Amparo Maternal Maternidade Social
São Paulo, Brazil, 04062-023
Sponsors and Collaborators
Edgard Costa de Vilhena
Amparo Maternal Maternidade Social (USaoPaulo)
Investigators
Principal Investigator: Edgard C Vilhena, MD Medicine School - University of São Paulo
  More Information

Additional Information:
Publications:

Responsible Party: Edgard Costa de Vilhena, MD, student PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00942097     History of Changes
Other Study ID Numbers: HAM-01082009, Homeopathy
Study First Received: July 16, 2009
Last Updated: May 8, 2013
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by University of Sao Paulo:
Homeopathy
overweight
obesity
mental disorder
pregnancy
Overweight pregnant women with suspicious mental disorder

Additional relevant MeSH terms:
Disease
Mental Disorders
Overweight
Psychotic Disorders
Body Weight
Pathologic Processes
Schizophrenia and Disorders with Psychotic Features
Signs and Symptoms

ClinicalTrials.gov processed this record on October 30, 2014