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

May 8, 2013 updated by: Edgard Costa de Vilhena

Homeopathic Treatment in Pregnant Women With Overweight and Mental Disorder: a Double Blinded Controlled Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

134

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Comorbidities
Time Frame: 9 months
9 months
Newborn weight
Time Frame: 9 months
9 months
Pregnancy period
Time Frame: 9 months
9 months
Collateral effects
Time Frame: 9 months
9 months
Self perception health
Time Frame: 9 months
9 months
Apgar score
Time Frame: 9 month
9 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edgard Costa de Vilhena

Collaborators

Amparo Maternal Maternidade Social

Investigators

  • Principal Investigator: Edgard C Vilhena, MD, Medicine School - University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

July 16, 2009

First Submitted That Met QC Criteria

July 17, 2009

First Posted (Estimate)

July 20, 2009

Study Record Updates

Last Update Posted (Estimate)

May 13, 2013

Last Update Submitted That Met QC Criteria

May 8, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HAM-01082009
  • Homeopathy (Other Identifier: 6904562)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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