Study Stopped
Difficulties in recruiting process
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
1 other identifier
interventional
62
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 9, 2016
CompletedFirst Posted
Study publicly available on registry
May 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedFebruary 28, 2019
February 1, 2019
1.5 years
May 9, 2016
February 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (10)
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
- +5 more secondary outcomes
Study Arms (4)
Diet + exercise + Carduus marianus 6cH
EXPERIMENTALDiet (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 + exercise + Carduus marianus 12cH
EXPERIMENTALDiet (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 + exercise + Carduus marianus 30cH
EXPERIMENTALDiet (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 + exercise + placebo
PLACEBO 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.
Interventions
aerobic exercise, 30 minutes, daily
1600 calories
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Nacional Homeopático, Mexicolead
- Laboratorio Similia, Méxicocollaborator
Study Sites (1)
Hospital Nacional Homeopático
Mexico City, Mexico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emma del Carmen Macias-Cortes, PhD
Hospital Nacional Homeopático
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
May 9, 2016
First Posted
May 17, 2016
Study Start
February 1, 2016
Primary Completion
August 1, 2017
Study Completion
September 1, 2017
Last Updated
February 28, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share