Qing'E Formula Therapy on Menopausal Symptoms

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

PHASE2/PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-10-31

Brief Summary

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

The objective of this study is to evaluate whether a Chinese medicine formula (Qing'E) is effective in alleviating menopausal symptoms and safety.

Related Clinical Trials

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

Pharmacokinetics Study of Qing'E Pill

NCT01931436

Menopause

COMPLETED PHASE1

RCT on the Treatment of Menopausal Syndrome With Chinese Medicine

NCT06074809

Menopause

NOT_YET_RECRUITING PHASE2

QXZS in Menopausal Syndrome Based on 16S rRNA Sequencing Technology

NCT06143696

Menopause

RECRUITING NA

Acupuncture for Relieving Perimenopausal Symptoms

NCT01933204

Perimenopause

COMPLETED PHASE2/PHASE3

A Clinical Study Assessing Efficacy of an Herbal Blend on Menopausal Symptoms and Quality of Life

NCT04228757

Menopause

UNKNOWN NA

Detailed Description

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

This is a double-blind placebo-controlled randomized clinical trial to evaluate whether a Chinese medicine formula (Qing'E, composed of eucommia, psoralen, walnuts and garlic) is effective in alleviating menopausal symptoms. 240 Chinese women with menopausal symptoms will be recruited and randomized into two groups. One is treatment group with 12 weeks of Qing'E pills (well-controlled), the other is controlled group with 12 weeks of placebo. The treatment outcome measures include: 1) the severity of menopausal symptoms: self-recording of daily frequency of vasomotor symptoms (hot flushes), the Kupperman index. 2) NEI network indices. 3) Urine metabolomics. All measures are conducted at baseline and endpoint except the self-recoding of vasomotor symptoms, Kupperman index and urine metabolomics. Tyhe investigators expect this research will provide an effective and safe therapy for menopausal symptoms.

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

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

Qing'E pills

9 g pills,twice a day for 12 weeks

Group Type ACTIVE_COMPARATOR

Qing'E pills

Intervention Type DRUG

composed of eucommia, psoralen, walnuts and garlic

Placebo

9 g pills,twice a day for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Containing 2% of Qing'E pills

Interventions

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

Qing'E pills

composed of eucommia, psoralen, walnuts and garlic

Intervention Type DRUG

Placebo

Containing 2% of Qing'E pills

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

1. Women age between 40 to 60 Years, Suffering from irregular menstrual cycle or amenorrhea of 3-11 months.
2. Moderate to severe hot flashes (associated with sweating)≥5 times /24 hours.
3. Patients unused estrogen tablets or progesterone injection in 6 months.
4. Patients must discontinue other therapies in the treatment of menopausal syndrome for more than 3 months.
5. Get subjects informed consent process should comply with GCP requirements.

Exclusion Criteria

1. Patients with hypertension, primary hypotension and chronic anemia (Hb ≤ 90 g / L).
2. Bilateral oophorectomy, endometrial lesions, uterine polyps, abnormal vaginal bleeding, severe breast hyperplasia, with family history of breast cancer.
3. Allergic constitution and known allergy to the drug.
4. Patients with diseases of the cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, or mentally ill.
5. Patients with hyperthyroidism, coronary atheroma, diabetes, obesity (body mass index of more than 30 kg/m2), migraine, malignant tumors, thromboembolic disease, gastrointestinal diseases affect absorption or autoimmune diseases.
6. Alcoholics or smokers (past or smoking).
7. Patients are participating in other clinical trials.

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No