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

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

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.

Study Overview

• Status: Terminated
• Conditions: Obesity; Dyslipidemia; Menopause
• Intervention / Treatment: Drug: Placebo; Drug: Carduus marianus 6cH; Behavioral: Exercise; Other: Diet; Drug: Carduus marianus 12cH; Drug: Carduus marianus 30cH

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico
    • Hospital Nacional Homeopático

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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.	Behavioral: Exercise; aerobic exercise, 30 minutes, daily; Other: Diet; 1600 calories; Drug: Carduus marianus 12cH
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.	Behavioral: Exercise; aerobic exercise, 30 minutes, daily; Other: Diet; 1600 calories; Drug: Carduus marianus 30cH
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline level of triglycerides at 4 and 8 weeks.	4 and 8 weeks after randomization
Change from baseline level of total cholesterol at 4 and 8 weeks.	4 and 8 weeks after randomization

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Nacional Homeopático, Mexico
• Collaborators: Laboratorio Similia, México
• Investigators: Principal Investigator: Emma del Carmen Macias-Cortes, PhD, Hospital Nacional Homeopático

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: May 9, 2016
• First Submitted That Met QC Criteria: May 13, 2016
• First Posted (Estimate): May 17, 2016

Study Record Updates

• Last Update Posted (Actual): February 28, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Obesity; Insulin resistance; Cholesterol; Dyslipidemia; Homeopathy; Triglycerides; LDL-cholesterol; HDL-cholesterol; Carduus marianus; Climacteric
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: HospitalNHMexico

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No