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A Study on the Improvement and Nutritional Health Management Application of Linolein in Patients with Perimenopausal Syndrome Based on Intestinal Microflora Exploration

A Study on the Improvement and Nutritional Health Management Application of Linolein in Patients with Perimenopausal Syndrome Based on Intestinal Microflora Exploration

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082537
Enrollment
Unknown
Registered
2024-04-01
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

menopausal syndrome

Interventions

Case group of menopausal syndrome:flax lignan
Healthy menopausal women as the healthy control group:Nonne

Sponsors

People's Hospital of Lianshui County
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 55 Years

Inclusion criteria

Inclusion criteria: (1) Age range from 45 to 55 years old; (2) Symptoms: ? Menstrual changes: menstrual cycle disorder, prolonged menstruation, decreased menstrual flow, or amenorrhea; ? Symptoms of vasodilation and contraction: hot flashes, sweating, palpitations, dizziness, or blood pressure fluctuations, etc Neuropsychiatric symptoms: anxiety, or depression, or poor sleep at night, excessive dreaming, or decreased memory ability; ? Symptoms of urogenital tract: dryness of the vagina, itching in the genital area, painful intercourse, or recurrent urinary tract infections, etc Skeletal muscle symptoms: joint pain, stiffness, or limited mobility, etc.; ? Skin symptoms: Dry skin, itching, or ant like sensation; (3) There may be an increase in follicle stimulating hormone (FSH) and a decrease in serum estradiol (E2) and anti Mullerian hormone (AMH); (4) Female patients with intact uterus and bilateral ovaries; (5) Kupperman score = 15 points; (6) There is no history of hormone therapy within the first three months prior to the start of the study; (7) Subjectively willing to participate and sign on the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Surgical intervention for removal of uterus or bilateral ovaries; (2) Those who experience continuous or excessive menstrual bleeding, such as collapse; (3) Individuals with the following serious underlying diseases: heart, brain, blood vessels, liver, kidney, hematopoietic system, etc; Suffering from serious diseases such as malignant tumors, cerebral infarction, metabolic disorders, etc; (4) Individuals with mental activity disorders; (5) Suffering from severe gastrointestinal diseases that have not been controlled, having undergone major gastrointestinal surgeries (cholecystectomy and appendectomy) within 5 years; (6) Inflammatory bowel disease, including ulcerative colitis, Crohn's disease, or uncertain colitis; (7) Persistent, infectious gastroenteritis, colitis or gastritis; The etiology of persistent or chronic diarrhea is unknown, with Clostridium difficile infection (recurrence) or Helicobacter pylori infection (untreated); (8) Irritable bowel syndrome; (9) Chronic constipation; (10) Historical gastric or intestinal ulcers, gastrointestinal bleeding, abdominal pain, indigestion, gastrointestinal urgency (heaviness) or difficulty in defecation, gastrointestinal or colon polyps or masses, developmental disorders or cancer, as well as diarrhea or infectious colitis.

Design outcomes

Primary

MeasureTime frame
Serum follicle stimulating hormone;Serum estradiol;Serum anti Mullerian hormone;Intestinal flora;Kupperman Rating Questionnaire;SF-36 Quality of Life Scale;

Secondary

MeasureTime frame
routine blood test;Routine urine test;liver function;fasting glucose;blood lipid;Uterine adnexal ultrasound;renal function;ECG examination;

Countries

China

Contacts

Public ContactQiaosheng Hu

People's Hospital of Lianshui County, Huai'an City, Jiangsu Province

fox1921@163.com+86 158 5177 2121

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026