Back to resultsHomeopathic Medication and Nutritional Oriented Diet to Treat Overweight Pregnant Women With Mental Disorder
Primary Purpose
Overweight, Pregnancy, Mental Disorder
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos
Homeopathy and Nutritional oriented diet
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring Homeopathy, overweight, obesity, mental disorder, pregnancy, Overweight pregnant women with suspicious mental disorder
Eligibility 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
Sites / Locations
- Amparo Maternal Maternidade Social
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Nutritional plus Placebo (homeopathy)
Nutr and Homeop Sulph Puls Lyc Lackt Con Sep Nuxv Calcc Phos
Arm Description
Nutritional oriented diet for pregnancy period add homeopathic preparation from inert substance.
Nutrition oriented diet for pregnancy period add active homeopathic medication (Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos)
Outcomes
Primary Outcome Measures
Weight
Secondary Outcome Measures
Comorbidities
Newborn weight
Pregnancy period
Collateral effects
Self perception health
Apgar score
Full Information
NCT ID
NCT00942097
First Posted
July 16, 2009
Last Updated
May 8, 2013
Sponsor
Edgard Costa de Vilhena
Collaborators
Amparo Maternal Maternidade Social
1. Study Identification
Unique Protocol Identification Number
NCT00942097
Brief Title
Homeopathic Medication and Nutritional Oriented Diet to Treat Overweight Pregnant Women With Mental Disorder
Official Title
Homeopathic Treatment in Pregnant Women With Overweight and Mental Disorder: a Double Blinded Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Edgard Costa de Vilhena
Collaborators
Amparo Maternal Maternidade Social
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Pregnancy, Mental Disorder
Keywords
Homeopathy, overweight, obesity, mental disorder, pregnancy, Overweight pregnant women with suspicious mental disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nutritional plus Placebo (homeopathy)
Arm Type
Placebo Comparator
Arm Description
Nutritional oriented diet for pregnancy period add homeopathic preparation from inert substance.
Arm Title
Nutr and Homeop Sulph Puls Lyc Lackt Con Sep Nuxv Calcc Phos
Arm Type
Active Comparator
Arm Description
Nutrition oriented diet for pregnancy period add active homeopathic medication (Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos)
Intervention Type
Drug
Intervention Name(s)
Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos
Other Intervention Name(s)
Sulphur, Puls, Lyc, Lack-t, Conium-m, Nux-v, Calc-c, Sep, Phosphorus
Intervention Description
CH 12 preparation, 6 drops, twice a day, 4 days per week, until the end of pregnancy. One medication per appointment.
Intervention Type
Drug
Intervention Name(s)
Homeopathy and Nutritional oriented diet
Intervention Description
Homeopathy 6 drops twice a day 4 days per week, active and placebo and Balanced nutritional oriented diet for both groups.
Primary Outcome Measure Information:
Title
Weight
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Comorbidities
Time Frame
9 months
Title
Newborn weight
Time Frame
9 months
Title
Pregnancy period
Time Frame
9 months
Title
Collateral effects
Time Frame
9 months
Title
Self perception health
Time Frame
9 months
Title
Apgar score
Time Frame
9 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edgard C Vilhena, MD
Organizational Affiliation
Medicine School - University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amparo Maternal Maternidade Social
City
São Paulo
ZIP/Postal Code
04062-023
Country
Brazil
12. IPD Sharing Statement
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Links:
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http://www.homeoint.org
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Homeopathé International
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http://www.ecomedicina.com.br
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Homeopathy and fitoteraphy information
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Homeopathic Medication and Nutritional Oriented Diet to Treat Overweight Pregnant Women With Mental Disorder
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