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

Arm | Intervention/treatment |
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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.
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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.
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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.
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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.
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Drug: Placebo Behavioral: Exercise aerobic exercise, 30 minutes, daily Other: Diet 1600 calories |
- Change from baseline level of triglycerides at 4 and 8 weeks. [ Time Frame: 4 and 8 weeks after randomization ]
- Change from baseline level of total cholesterol at 4 and 8 weeks. [ Time Frame: 4 and 8 weeks after randomization ]
- Change from baseline level of LDL cholesterol at 4 and 8 weeks. [ Time Frame: 4 and 8 weeks after randomization ]
- Change from baseline level of HDL cholesterol at 4 and 8 weeks. [ Time Frame: 4 and 8 weeks after randomization ]
- Change from baseline level of fasting glucose at 4 and 8 weeks. [ Time Frame: 4 and 8 weeks after randomization ]
- Change from baseline level of glycosylated hemoglobin at 4 and 8 weeks. [ Time Frame: 4 and 8 weeks after randomization ]
- 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 ]
- Change from baseline weight (kg) at 4 and 8 weeks. [ Time Frame: 4 and 8 weeks after randomization ]
- Change from baseline body mass index (Kg/m2) at 4 and 8 weeks. [ Time Frame: 4 and 8 weeks after randomization ]
- Change from baseline waist circumference (cm) at 4 and 8 weeks. [ Time Frame: 4 and 8 weeks after randomization ]
- 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.
- 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.

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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 |
Inclusion Criteria:
- women 40-65 years in early or late transition to menopause or postmenopause according to STRAW classification
- hypertriglyceridemia [>150 <1000 mg/dL], and/or hypercholesterolemia [>200mg/dL]
- overweight or obesity [BMI >25 Kg/m2]
- fasting glucose <126mg/dL
- glycosylated hemoglobin <6.5%
- be willing and capable to follow study procedures.
Exclusion Criteria:
- history of cardiovascular disease or coronary risk equivalents
- secondary hyperlipidemia caused by diabetes mellitus, renal, liver or thyroid diseases
- 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
- 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
- pregnancy or breastfeeding.

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
Mexico | |
Hospital Nacional Homeopático | |
Mexico City, Mexico |
Principal Investigator: | Emma del Carmen Macias-Cortes, PhD | Hospital Nacional Homeopático |
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 |
Homeopathy Carduus marianus Dyslipidemia Climacteric Obesity |
Triglycerides Cholesterol Insulin resistance LDL-cholesterol HDL-cholesterol |
Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |