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OverweightPhase 2/3NCT00942097

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

A Phase 2/3 study testing Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos and Homeopathy and Nutritional oriented diet in people with Overweight and Pregnancy, run by Edgard Costa de Vilhena at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Overweight, Pregnancy, Mental Disorder
What is being tested?
Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos and Homeopathy and Nutritional oriented diet
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
134 participants
Where
1 siteBrazil
Study dates
Aug 2009to Dec 2012
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Pregnant women with less than 28 weeks,
  • BMI from 26 to 35 Kg/ m2,
  • SRQ-20 positive.

Who cannot join

  • Diabetes
  • Cardiopathies
  • Hypertension
  • Nephropathies
  • Psychiatric treatment
  • Drug users
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Amparo Maternal Maternidade Social

    São Paulo, São Paulo, 04062-023

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Being tested
Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos, Homeopathy and Nutritional oriented diet
Keywords
Homeopathy, overweight, obesity, mental disorder, pregnancy, Overweight pregnant women with suspicious mental disorder
Medical subject headings
Overweight, Mental Disorders, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Sulphur, Puls, Lyc, Lack-t

    CH 12 preparation, 6 drops, twice a day, 4 days per week, until the end of pregnancy. One medication per appointment.

  • Homeopathy and Nutritional oriented dietDrug

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

Study groups in NCT00942097
Study groupRoleWhat they receive
Nutritional plus Placebo (homeopathy)Placebo comparatorNutritional oriented diet for pregnancy period add homeopathic preparation from inert substance.
Receives: Drug: Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos; Drug: Homeopathy and Nutritional oriented diet
Nutr and Homeop Sulph Puls Lyc Lackt Con Sep Nuxv Calcc PhosActive comparatorNutrition oriented diet for pregnancy period add active homeopathic medication (Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos)
Receives: Drug: Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos; Drug: Homeopathy and Nutritional oriented diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight

    Measured: 9 months

Secondary outcomes (6)

  1. Comorbidities

    Measured: 9 months

  2. Newborn weight

    Measured: 9 months

  3. Pregnancy period

    Measured: 9 months

  4. Collateral effects

    Measured: 9 months

  5. Self perception health

    Measured: 9 months

  6. Apgar score

    Measured: 9 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00942097
Sponsor's protocol ID
HAM-01082009
Other IDs
Homeopathy
Status last verified
May 2013
First submitted
16 Jul 2009
Last updated
13 May 2013
Results posted
No
Data monitoring committee
No

Publications

  • Keppel KG, Taffel SM. Pregnancy-related weight gain and retention: implications of the 1990 Institute of Medicine guidelines. Am J Public Health. 1993 Aug;83(8):1100-3. doi: 10.2105/ajph.83.8.1100.

    PubMed 8342716

  • Horton R. The neglected epidemic of chronic disease. Lancet. 2005 Oct 29-Nov 4;366(9496):1514. doi: 10.1016/S0140-6736(05)67454-5. No abstract available.

    PubMed 16257331

  • Strong K, Mathers C, Leeder S, Beaglehole R. Preventing chronic diseases: how many lives can we save? Lancet. 2005 Oct 29-Nov 4;366(9496):1578-82. doi: 10.1016/S0140-6736(05)67341-2.

    PubMed 16257345

  • Fuster V, Voute J. MDGs: chronic diseases are not on the agenda. Lancet. 2005 Oct 29-Nov 4;366(9496):1512-4. doi: 10.1016/S0140-6736(05)67610-6. No abstract available.

    PubMed 16257330

  • Monteiro CA, Conde WL, Popkin BM. Is obesity replacing or adding to undernutrition? Evidence from different social classes in Brazil. Public Health Nutr. 2002 Feb;5(1A):105-12. doi: 10.1079/PHN2001281.

    PubMed 12027272

  • Yang D, Fontaine KR, Wang C, Allison DB. Weight loss causes increased mortality: cons. Obes Rev. 2003 Feb;4(1):9-16. doi: 10.1046/j.1467-789x.2003.00092.x.

    PubMed 12608523

  • Hubert HB, Feinleib M, McNamara PM, Castelli WP. Obesity as an independent risk factor for cardiovascular disease: a 26-year follow-up of participants in the Framingham Heart Study. Circulation. 1983 May;67(5):968-77. doi: 10.1161/01.cir.67.5.968.

    PubMed 6219830

  • Frankel PH. Obesity and cancer. N Engl J Med. 2003 Jul 31;349(5):502-4; author reply 502-4. No abstract available.

    PubMed 12892102

  • Allison DB, Saunders SE. Obesity in North America. An overview. Med Clin North Am. 2000 Mar;84(2):305-32, v. doi: 10.1016/s0025-7125(05)70223-6.

    PubMed 10793644

  • Allison DB, Fontaine KR, Manson JE, Stevens J, VanItallie TB. Annual deaths attributable to obesity in the United States. JAMA. 1999 Oct 27;282(16):1530-8. doi: 10.1001/jama.282.16.1530.

    PubMed 10546692

  • Harris T, Cook EF, Garrison R, Higgins M, Kannel W, Goldman L. Body mass index and mortality among nonsmoking older persons. The Framingham Heart Study. JAMA. 1988 Mar 11;259(10):1520-4.

    PubMed 3339789

  • Chu SY, Callaghan WM, Kim SY, Schmid CH, Lau J, England LJ, Dietz PM. Maternal obesity and risk of gestational diabetes mellitus. Diabetes Care. 2007 Aug;30(8):2070-6. doi: 10.2337/dc06-2559a. Epub 2007 Apr 6.

    PubMed 17416786

  • Ohlin A, Rossner S. Maternal body weight development after pregnancy. Int J Obes. 1990 Feb;14(2):159-73.

    PubMed 2341224

  • Greene GW, Smiciklas-Wright H, Scholl TO, Karp RJ. Postpartum weight change: how much of the weight gained in pregnancy will be lost after delivery? Obstet Gynecol. 1988 May;71(5):701-7.

    PubMed 3357658

  • Linne Y, Barkeling B, Rossner S. Long-term weight development after pregnancy. Obes Rev. 2002 May;3(2):75-83. doi: 10.1046/j.1467-789x.2002.00061.x.

    PubMed 12120423

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Sulph, Puls, Lyc, Lack t, Con, Sep, Nux v, Calc c, Phos and Homeopathy and Nutritional oriented diet in people with Overweight and Pregnancy, run by Edgard Costa de Vilhena at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00942097, which also lists 67 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2013.

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