AzTrials
AzTrials

DyslipidemiaPhase 2NCT02775448

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

A Phase 2 study testing Carduus marianus 6cH, Carduus marianus 12cH and Carduus marianus 30cH in people with Dyslipidemia and Menopause, run by Hospital Nacional Homeopático, Mexico at 1 site in Mexico.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 40 to 65 years, women only
Conditions the study is for
Dyslipidemia, Menopause, Obesity
What is being tested?
Carduus marianus 6cH, Carduus marianus 12cH and Carduus marianus 30cH
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
1 siteMexico
Study dates
Feb 2016to Sep 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Hospital Nacional Homeopático

    Mexico City

Other trials in Mexico

About this study

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

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.

Read the 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.

Being tested
Carduus marianus 6cH, Carduus marianus 12cH, Carduus marianus 30cH, Placebo, Exercise
Keywords
Homeopathy, Carduus marianus, Dyslipidemia, Climacteric, Obesity, Triglycerides, Cholesterol, Insulin resistance, LDL-cholesterol, HDL-cholesterol
Medical subject headings
Dyslipidemias, Obesity, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carduus marianus 6cHDrug

  • Carduus marianus 12cHDrug

  • Carduus marianus 30cHDrug

  • PlaceboDrug

  • ExerciseBehavioural

    aerobic exercise, 30 minutes, daily

  • DietOther

    1600 calories

Study groups in NCT02775448
Study groupRoleWhat they receive
Diet + exercise + Carduus marianus 6cHExperimentalDiet (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.
Receives: Drug: Carduus marianus 6cH; Behavioral: Exercise; Other: Diet
Diet + exercise + Carduus marianus 12cHExperimentalDiet (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.
Receives: Drug: Carduus marianus 12cH; Behavioral: Exercise; Other: Diet
Diet + exercise + Carduus marianus 30cHExperimentalDiet (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.
Receives: Drug: Carduus marianus 30cH; Behavioral: Exercise; Other: Diet
Diet + exercise + placeboPlacebo comparatorDiet (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.
Receives: Drug: Placebo; Behavioral: Exercise; Other: Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 4 and 8 weeks after randomization

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

    Measured: 4 and 8 weeks after randomization

Secondary outcomes (10)

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

    Measured: 4 and 8 weeks after randomization

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

    Measured: 4 and 8 weeks after randomization

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

    Measured: 4 and 8 weeks after randomization

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

    Measured: 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.

    Measured: 4 and 8 weeks after randomization

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

    Measured: 4 and 8 weeks after randomization

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

    Measured: 4 and 8 weeks after randomization

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

    Measured: 4 and 8 weeks after randomization

  9. Adverse events

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

    Measured: 4 weeks after randomization

  10. Adverse events

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

    Measured: 8 weeks after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionAug 2017
  4. Study completionSep 2017

Why it stopped: Difficulties in recruiting process

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02775448
Sponsor's protocol ID
HospitalNHMexico
Status last verified
Feb 2019
First submitted
9 May 2016
Last updated
28 Feb 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carduus marianus 6cH, Carduus marianus 12cH and Carduus marianus 30cH in people with Dyslipidemia and Menopause, run by Hospital Nacional Homeopático, Mexico at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Difficulties in recruiting process). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline level of triglycerides at 4 and 8 weeks. (time frame: 4 and 8 weeks after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02775448.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in