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Dose-response Study of Carduus Marianus in Centesimal Scale for Dyslipidemia in Climacteric Overweighed or Obese Women.

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ClinicalTrials.gov Identifier: NCT02775448
Recruitment Status : Terminated (Difficulties in recruiting process)
First Posted : May 17, 2016
Last Update Posted : February 28, 2019
Sponsor:
Collaborator:
Laboratorio Similia, México
Information provided by (Responsible Party):
Emma del Carmen Macías-Cortés, PhD, Hospital Nacional Homeopático, Mexico

Study Description
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Brief Summary:
Metabolic disorders including hypercholesterolemia and hypertriglyceridemia are present in climacteric women. Carduus marianus is a homeopathic medicine that traditionally has been used for hepatic diseases. It has been used for reducing hypercholesterolemia and hypertriglyceridemia also. The aim of this study is to investigate the most effective dose of Carduus marianus in centesimal scale (6cH, 12cH, 30cH, placebo) plus diet and exercise for reducing hypertriglyceridemia and/or hypercholesterolemia in climacteric women.

Condition or disease Intervention/treatment Phase
Dyslipidemia Menopause Obesity Drug: Carduus marianus 6cH Drug: Carduus marianus 12cH Drug: Carduus marianus 30cH Drug: Placebo Behavioral: Exercise Other: Diet Phase 2

Detailed Description:

The prevalence of metabolic disorders including dyslipidemia increases as women transition from premenopause to postmenopause. This increases the risk for morbidity and mortality from cardiovascular diseases. Carduus marianus is a homeopathic medicine that traditionally has been used for hepatic diseases. Silymarin, isolated from Carduus marianus, owe its therapeutic and hepatoprotective effects to its strong antioxidant and anti-inflammatory properties. Carduus marianus is frequently used in clinical practice and reduces plasma level of triglycerides, total cholesterol and LDL in humans with dyslipidemia. Not all homeopaths agree on dosage and potency when prescribing homeopathic medicines. The aim of this study is to assess: (1) the most effective dose of Carduus marianus in centesimal scale for reducing hypertriglyceridemia and/or hypercholesterolemia in climacteric women; (2) the effect of Carduus marianus in other metabolic parameters (glucose, glycosylated hemoglobin, insulin resistance, weight, body mass index, waist circumference).

This is a 8-week, double-blind, randomized, parallel, four-group, dose-response study to assess the safety and efficacy of Carduus marianus in 6cH, 12cH, 30cH and placebo plus diet and exercise, for reducing hypertriglyceridemia and/or hypercholesterolemia in climacteric women.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dose-response Study of the Efficacy and Safety of Carduus Marianus in Centesimal Scale for Dyslipidemia in Overweighed or Obese Women in Peri- and Postmenopause: a Randomized Controlled Trial
Actual Study Start Date : February 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : September 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Diet + exercise + Carduus marianus 6cH
Diet (1600 cal/day) + aerobic exercise (30 min daily) + Carduus marianus 6cH, 24 drops diluted in 20 ml of water, by mouth, every 8 hours for 8 weeks.
 Drug: Carduus marianus 6cH
Behavioral: Exercise
aerobic exercise, 30 minutes, daily

Other: Diet
1600 calories
Experimental: Diet + exercise + Carduus marianus 12cH
Diet (1600 cal/day) + aerobic exercise (30 min daily) + Carduus marianus 12cH, 24 drops diluted in 20 ml of water, by mouth, every 8 hours for 8 weeks.
 Drug: Carduus marianus 12cH
Behavioral: Exercise
aerobic exercise, 30 minutes, daily

Other: Diet
1600 calories
Experimental: Diet + exercise + Carduus marianus 30cH
Diet (1600 cal/day) + aerobic exercise (30 min daily) + Carduus marianus 30c, 24 drops diluted in 20 ml of water, by mouth, every 8 hours for 8 weeks.
 Drug: Carduus marianus 30cH
Behavioral: Exercise
aerobic exercise, 30 minutes, daily

Other: Diet
1600 calories
Placebo Comparator: Diet + exercise + placebo
Diet (1600 cal/day) + aerobic exercise (30 min daily) + placebo (87°alcohol), 24 drops diluted in 20 ml of water, by mouth, every 8 hours for 8 weeks.
 Drug: Placebo
Behavioral: Exercise
aerobic exercise, 30 minutes, daily

Other: Diet
1600 calories


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline level of triglycerides at 4 and 8 weeks. [ Time Frame: 4 and 8 weeks after randomization ]
  2. Change from baseline level of total cholesterol at 4 and 8 weeks. [ Time Frame: 4 and 8 weeks after randomization ]

Secondary Outcome Measures :
  1. Change from baseline level of LDL cholesterol at 4 and 8 weeks. [ Time Frame: 4 and 8 weeks after randomization ]
  2. Change from baseline level of HDL cholesterol at 4 and 8 weeks. [ Time Frame: 4 and 8 weeks after randomization ]
  3. Change from baseline level of fasting glucose at 4 and 8 weeks. [ Time Frame: 4 and 8 weeks after randomization ]
  4. Change from baseline level of glycosylated hemoglobin at 4 and 8 weeks. [ Time Frame: 4 and 8 weeks after randomization ]
  5. Change from baseline [HOMA-IR=insulin(mU/ml) X glucose (mg/dl)/405] at 4 and 8 weeks. [ Time Frame: 4 and 8 weeks after randomization ]
  6. Change from baseline weight (kg) at 4 and 8 weeks. [ Time Frame: 4 and 8 weeks after randomization ]
  7. Change from baseline body mass index (Kg/m2) at 4 and 8 weeks. [ Time Frame: 4 and 8 weeks after randomization ]
  8. Change from baseline waist circumference (cm) at 4 and 8 weeks. [ Time Frame: 4 and 8 weeks after randomization ]
  9. Adverse events [ Time Frame: 4 weeks after randomization ]
    Untoward medical occurrence associated with the use of a drugs in humans, whether or not considered drug related.

  10. Adverse events [ Time Frame: 8 weeks after randomization ]
    Untoward medical occurrence associated with the use of a drugs in humans, whether or not considered drug related.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. women 40-65 years in early or late transition to menopause or postmenopause according to STRAW classification
  2. hypertriglyceridemia [>150 <1000 mg/dL], and/or hypercholesterolemia [>200mg/dL]
  3. overweight or obesity [BMI >25 Kg/m2]
  4. fasting glucose <126mg/dL
  5. glycosylated hemoglobin <6.5%
  6. be willing and capable to follow study procedures.

Exclusion Criteria:

  1. history of cardiovascular disease or coronary risk equivalents
  2. secondary hyperlipidemia caused by diabetes mellitus, renal, liver or thyroid diseases
  3. hypolipidemic agents, antidiabetic medication, hormone replacement therapy, tamoxifen, raloxifene, danazol, isotretinoin, acitretin, cyclosporin, azathioprine, protease inhibitors (amprenavir, indinavir, nelfinavir, ritonavir, saquinavir), antipsychotics (clozapine), seizure medication (carbamazepine, valproic acid, phenobarbital, phenytoin) either on-going or any time in the previous 2 months
  4. any other clinically significant illness that, in the opinion of the investigator, might put the patient at risk of harm during the study or might adversely affect the interpretation of the study data
  5. pregnancy or breastfeeding.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02775448


Locations
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Mexico
Hospital Nacional Homeopático
Mexico City, Mexico
Sponsors and Collaborators
Hospital Nacional Homeopático, Mexico
Laboratorio Similia, México
Investigators
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Principal Investigator: Emma del Carmen Macias-Cortes, PhD Hospital Nacional Homeopático
More Information
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Responsible Party: Emma del Carmen Macías-Cortés, PhD, Dr., Hospital Nacional Homeopático, Mexico
ClinicalTrials.gov Identifier: NCT02775448    
Other Study ID Numbers: HospitalNHMexico
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Emma del Carmen Macías-Cortés, PhD, Hospital Nacional Homeopático, Mexico:
Homeopathy
Carduus marianus
Dyslipidemia
Climacteric
Obesity
 Triglycerides
Cholesterol
Insulin resistance
LDL-cholesterol
HDL-cholesterol
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases