Effect of Red Clover on Menopause Symptoms and Lipid Profile

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-20

Study Completion Date

2023-09-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical trial is to investigate the effects of red clover isoflavones on menopausal symptoms and lipid profile in menopausal females.This prospective randomized, double-blind, placebo-controlled study included postmenopausal women with dyslipidemia. The red clover group received 40 mg isoflavone red clover capsule twice daily for 6 months, while placebo was 40 mg starch capsules, twice daily. Data were collected at baseline, 3 months and 6 months. The study was completed with 75 subjects \[red clover (n = 39), placebo (n = 36)\]. Menopause Rating Scale (MRS) was applied to calculate subdimension and total scores. Blood lipid profile, including total cholesterol, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C) and triglyceride levels were measured.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Alternative Treatments for Menopausal Women

NCT02028702

Menopause Hot Flushes Osteoporosis +1 more

COMPLETED NA

Use of Black Cohosh and Red Clover for the Relief of Menopausal Symptoms

NCT00066144

Hot Flashes Menopause

COMPLETED PHASE2

Single-Dose Study of Black Cohosh and Red Clover

NCT00010959

Menopause

COMPLETED PHASE1

Diet, Cardiometabolic Risk (CM) and Menopause Symptoms

NCT05764473

Metabolic Syndrome, Protection Against Menopause

COMPLETED NA

Clinical Trial to Evaluate the Efficacy of FITOGYN Versus Placebo on the Vasomotor Symptomatology Associated With Menopause

NCT01116310

Postmenopausal Women With Moderate Vasomotor Symptoms

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The goal of this clinical trial is to investigate the effects of red clover isoflavones on menopausal symptoms and lipid profile in menopausal females. This was a prospective, randomized, double-blind, placebo-controlled study conducted between March 2022 and September 2023 in the Departments of Gynecology and Internal Medicine of Medipol University Hospital, Istanbul, Turkey. The subjects were divided into two groups: red clover and placebo groups. For the randomization process, patients were provided with slips of paper bearing numbers starting from 1, assigned based on the order of admission by the admitting physician. Subsequently, they were directed to the appropriate nurse. The outpatient clinic nurse assigned red clover treatment to subjects with an odd-numbered slip and placebo to those with an even-numbered slip. The nurse documented the medication assigned to each patient, while the researchers and subjects remained blinded to this information. Red clover (Promensil, PharmaCare Europe Ltd., UK) and placebo (starch capsules) were administered orally twice a day with an interval of 12 hours for a total period of 6 months. Red clover capsules contained 40 mg of standardized red clover isoflavones in each capsule \[genistein (1 mg), daidzein (1 mg), biochanin A (23 mg) and biochanin B (formononetin, 15 mg)\]. Placebo capsules were ordered to be prepared with the same color, taste and smell as the red cover capsules. The patients' total cholesterol, low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C) and triglyceride levels were measured using the enzymatic colorimetric method (Hitachi 747 autoanalyzer; Germany) from antecubital venous blood samples taken at 8 AM after a 12-hour overnight fast at baseline, at 3-month follow-up and at 6-month follow-up. The severity of menopausal symptoms was assessed utilizing the Menopause Rating Scale (MRS). Data were collected at baseline, 3 months and 6 months. The study was completed with 75 subjects \[red clover (n = 39), placebo (n = 36)\].

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Menopause

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study included postmenopausal women who had naturally entered menopause and had applied to the outpatient clinics of Istanbul Medipol University Internal Medicine or Gynecology Departments with symptoms of menopause. Other inclusion criteria were: having a history of amenorrhea for at least 12 months, being aged 45-55, having received a diagnosis of dyslipidemia (at the present admission or within the past 3 months), not receiving treatment for dyslipidemia, absence of other chronic diseases, having a follicle stimulating hormone level of \>40 pg/mL and having a body mass index (BMI) of \<30 kg/m2.The subjects were divided into two groups: red clover and placebo groups.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

For the randomization process, patients were provided with slips of paper bearing numbers starting from 1, assigned based on the order of admission by the admitting physician. Subsequently, they were directed to the appropriate nurse. The outpatient clinic nurse assigned red clover treatment to subjects with an odd-numbered slip and placebo to those with an even-numbered slip. The nurse documented the medication assigned to each patient, while the researchers and subjects remained blinded to this information

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

red clover

Red clover (Promensil, PharmaCare Europe Ltd., UK) and placebo (starch capsules) were administered orally twice a day with an interval of 12 hours for a total period of 6 months. Red clover capsules contained 40 mg of standardized red clover isoflavones in each capsule \[genistein (1 mg), daidzein (1 mg), biochanin A (23 mg) and biochanin B (formononetin, 15 mg)\].

Group Type ACTIVE_COMPARATOR

red clover

Intervention Type DIETARY_SUPPLEMENT

Red clover (Promensil, PharmaCare Europe Ltd., UK) and placebo (starch capsules) were administered orally twice a day with an interval of 12 hours for a total period of 6 months.

placebo

Placebo capsules were ordered to be prepared with the same color, taste and smell as the red cover capsules. Placebo capsules were administered orally twice a day with an interval of 12 hours for a total period of 6 months.

Group Type PLACEBO_COMPARATOR

red clover

Intervention Type DIETARY_SUPPLEMENT

Red clover (Promensil, PharmaCare Europe Ltd., UK) and placebo (starch capsules) were administered orally twice a day with an interval of 12 hours for a total period of 6 months.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

red clover

Red clover (Promensil, PharmaCare Europe Ltd., UK) and placebo (starch capsules) were administered orally twice a day with an interval of 12 hours for a total period of 6 months.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

History of amenorrhea for at least 12 months

Being aged 45-55

Having received a diagnosis of dyslipidemia (at the present admission or within the past 3 months)

Not receiving treatment for dyslipidemia

Absence of other chronic diseases

Follicle stimulating hormone level of \>40 pg/mL

Body mass index (BMI) of \<30 kg/m2

Exclusion Criteria

Currently or previously undergoing hormone replacement therapy (either in the past, immediately before, or during the study)

Using any phytotherapeutic drug

Diagnosed with diabetes

Presence of anemia

Presence of cardiovascular disease Presence of musculoskeletal disease

Presence of asthma / chronic obstructive pulmonary disease

Presence of malignancy

Prsence of genital or gynecological disease (excluding menopausal symptoms)

Presence of neurological or psychiatric disease

Conditions involving acute or chronic inflammation

Experiencing acute or chronic infection

Displaying abnormal liver, kidney, or thyroid function tests

Engaging in smoking, alcohol consumption, or drug use

Suffering from sexual dysfunction (except for menopause-related reasons)

Unable to complete the study, or not attending 3-month or 6-month follow-up

Minimum Eligible Age

45 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes