Homeopathic Medication and Nutritional Oriented Diet to Treat Overweight Pregnant Women With Mental Disorder
This study has been completed.
Sponsor:
Edgard Costa de Vilhena
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
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:
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
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:
|
Mental Disorders Psychotic Disorders Overweight |
Schizophrenia and Disorders with Psychotic Features Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013