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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02775448
• Other study ID #: HospitalNHMexico
• Status: Terminated
• Phase: Phase 2
• Start date: February 2016
• Est. completion date: September 2017

Study information

• Verified date: February 2019
• Source: Hospital Nacional Homeopático, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Menopause
• Obesity

Intervention

Drug:
• Carduus marianus 6cH

• Carduus marianus 12cH

• Carduus marianus 30cH

• Placebo

Behavioral:
• Exercise
aerobic exercise, 30 minutes, daily

Other:
• Diet
1600 calories

Locations

Country	Name	City	State
Mexico	Hospital Nacional Homeopático	Mexico City

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Nacional Homeopático, Mexico	Laboratorio Similia, México

Country where clinical trial is conducted

Mexico, 

Outcome

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