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

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ClinicalTrials.gov Identifier: NCT00942097
Recruitment Status : Completed
First Posted : July 20, 2009
Last Update Posted : May 13, 2013
Sponsor:
Collaborator:
Amparo Maternal Maternidade Social
Information provided by (Responsible Party):
Edgard Costa de Vilhena, University of Sao Paulo

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.

Condition or disease Intervention/treatment 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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Homeopathic Treatment in Pregnant Women With Overweight and Mental Disorder: a Double Blinded Controlled Clinical Trial
Study Start Date : August 2009
Primary Completion Date : December 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Weight [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Comorbidities [ Time Frame: 9 months ]
  2. Newborn weight [ Time Frame: 9 months ]
  3. Pregnancy period [ Time Frame: 9 months ]
  4. Collateral effects [ Time Frame: 9 months ]
  5. Self perception health [ Time Frame: 9 months ]
  6. Apgar score [ Time Frame: 9 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942097


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

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 ( Other Identifier: 6904562 )
First Posted: July 20, 2009    Key Record Dates
Last Update Posted: May 13, 2013
Last Verified: May 2013

Keywords provided by Edgard Costa de Vilhena, University of Sao Paulo:
Homeopathy
overweight
obesity
mental disorder
pregnancy
Overweight pregnant women with suspicious mental disorder

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