Homeopathic Medication and Nutritional Oriented Diet to Treat Overweight Pregnant Women With Mental Disorder - Full Text View

Sponsor:	University of Sao Paulo
Collaborator:	Amparo Maternal Maternidade Social
Information provided by:	University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00942097

Sponsor:

University of Sao Paulo

Collaborator:

Amparo Maternal Maternidade Social

Information provided by:

University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT00942097

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 Pregnant 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:

MedlinePlus related topics: Mental Disorders Obesity Psychotic Disorders

Drug Information available for: Phosphorus

U.S. FDA Resources

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 ]

Estimated Enrollment:	150
Study Start Date:	August 2009
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Nutritional 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.
Experimental: Homeopathy Nutrition oriented diet for pregnancy period add active homeopathic medication.	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.

Arms

Assigned Interventions

Active Comparator: Nutritional

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.

Experimental: Homeopathy

Nutrition oriented diet for pregnancy period add active homeopathic medication.

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.

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

Responsible Party:	Euclides Ayres de Castilho, University of São Paulo
ClinicalTrials.gov Identifier:	NCT00942097 History of Changes
Other Study ID Numbers:	HAM-01082009, Homeopathy
Study First Received:	July 16, 2009
Last Updated:	May 3, 2011
Health Authority:	Brazil: National Health Surveillance Agency

Brazil
Amparo Maternal Maternidade Social
São Paulo, Brazil, 04062-023