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NCT02775448
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
Phase 2 trial testing Carduus marianus 6cH in Dyslipidemia in 62 participants. Terminated before completion.
1 August 2017
Quick facts
| Lead sponsor | Hospital Nacional Homeopático, Mexico |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 62 |
| Start date | 1 February 2016 |
| Primary completion | 1 August 2017 |
| Estimated completion | 1 September 2017 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- Carduus marianus 6cH — full drug profile →
- Carduus marianus 12cH — full drug profile →
- Carduus marianus 30cH — full drug profile →
- Placebo
- Exercise
- Diet
Conditions studied
- Dyslipidemia — all drugs for Dyslipidemia →
- Menopause — all drugs for Menopause →
- Obesity — all drugs for Obesity →
Sponsor
Hospital Nacional Homeopático, Mexico
Who can join
Adults 40 to 65, female only, with Dyslipidemia or Menopause. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Change from baseline level of triglycerides at 4 and 8 weeks.
Time frame: 4 and 8 weeks after randomization -
Change from baseline level of total cholesterol at 4 and 8 weeks.
Time frame: 4 and 8 weeks after randomization
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02775448
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02775448 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital Nacional Homeopático, Mexico
- Last refreshed: 26 February 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02775448.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing