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Completed

NCT Number: NCT00942097

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

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.

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Key information

Conditions

Overweight Body Weight Mental Disorder Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Pregnancy Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Amparo Maternal Maternidade Social

São Paulo, 04062-023, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos

Drug

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

Homeopathy and Nutritional oriented diet

Drug

Homeopathy 6 drops twice a day 4 days per week, active and placebo and Balanced nutritional oriented diet for both groups.

Primary outcomes

  1. Weight

    Time frame: 9 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Edgard Costa de Vilhena

Other

Collaborators

  • Amparo Maternal Maternidade Social

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 20, 2009
Registry last updated
May 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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