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

Primary Purpose

Dyslipidemia, Menopause, Obesity

Status

Terminated

Phase

Phase 2

Locations

Mexico

Study Type

Interventional

Intervention

Carduus marianus 6cH

Carduus marianus 12cH

Carduus marianus 30cH

Placebo

Exercise

Diet

About this trial

This is an interventional treatment trial for Dyslipidemia focused on measuring Homeopathy, Carduus marianus, Dyslipidemia, Climacteric, Obesity, Triglycerides, Cholesterol, Insulin resistance, LDL-cholesterol, HDL-cholesterol

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Hospital Nacional Homeopático

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Diet + exercise + Carduus marianus 6cH

Diet + exercise + Carduus marianus 12cH

Diet + exercise + Carduus marianus 30cH

Diet + exercise + placebo

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline level of triglycerides at 4 and 8 weeks.

Change from baseline level of total cholesterol at 4 and 8 weeks.

Secondary Outcome Measures

Change from baseline level of LDL cholesterol at 4 and 8 weeks.

Change from baseline level of HDL cholesterol at 4 and 8 weeks.

Change from baseline level of fasting glucose at 4 and 8 weeks.

Change from baseline level of glycosylated hemoglobin at 4 and 8 weeks.

Change from baseline [HOMA-IR=insulin(mU/ml) X glucose (mg/dl)/405] at 4 and 8 weeks.

Change from baseline weight (kg) at 4 and 8 weeks.

Change from baseline body mass index (Kg/m2) at 4 and 8 weeks.

Change from baseline waist circumference (cm) at 4 and 8 weeks.

Adverse events

Untoward medical occurrence associated with the use of a drugs in humans, whether or not considered drug related.

Adverse events

Untoward medical occurrence associated with the use of a drugs in humans, whether or not considered drug related.

Full Information

NCT ID

NCT02775448

First Posted

May 9, 2016

Last Updated

February 26, 2019

Sponsor

Hospital Nacional Homeopático, Mexico

Collaborators

Laboratorio Similia, México

1. Study Identification

Unique Protocol Identification Number

NCT02775448

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Terminated

Why Stopped

Difficulties in recruiting process

Study Start Date

February 2016 (Actual)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Nacional Homeopático, Mexico

Collaborators

Laboratorio Similia, México

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslipidemia, Menopause, Obesity

Keywords

Homeopathy, Carduus marianus, Dyslipidemia, Climacteric, Obesity, Triglycerides, Cholesterol, Insulin resistance, LDL-cholesterol, HDL-cholesterol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Diet + exercise + Carduus marianus 6cH

Arm Type

Experimental

Arm Description

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.

Arm Title

Diet + exercise + Carduus marianus 12cH

Arm Type

Experimental

Arm Description

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.

Arm Title

Diet + exercise + Carduus marianus 30cH

Arm Type

Experimental

Arm Description

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.

Arm Title

Diet + exercise + placebo

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Carduus marianus 6cH

Intervention Type

Drug

Intervention Name(s)

Carduus marianus 12cH

Intervention Type

Drug

Intervention Name(s)

Carduus marianus 30cH

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Type

Behavioral

Intervention Name(s)

Exercise

Intervention Description

aerobic exercise, 30 minutes, daily

Intervention Type

Other

Intervention Name(s)

Diet

Intervention Description

1600 calories

Primary Outcome Measure Information:

Title

Change from baseline level of triglycerides at 4 and 8 weeks.

Time Frame