Study of the Safety and Efficacy of Jiawen Qinge Fang (dispensing granules) for menopausal Symptoms in perimenopausal Women

A Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Trial of Jiawen Qinge Fang (dispensing granules) for Treatment of menopausal Symptoms in perimenopausal women

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-09000510

Enrollment

Unknown

Registered

2009-08-27

Start date

2009-09-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Menopausal Symptoms

Interventions

Group B:Placebo (3.5g dispensing granules), orally taken

Group A:Jiawei Qing'e Fang (3.5g dispensing granules), oral

Eligibility

Sex/Gender

Female

Age

45 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. female aged 45 to 55 years old; 2. in their perimenopausal period(marked by irregular cycles and menopausal symptoms); 3. FSH(follicle stimulating hormone)level>=30IU/L, at least 14 hot flushes per week within the past four weeks; 4. signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Mammary hyperplasia,endometrial hyperplasia, metropolypus and undiagnosed vaginal bleeding; 2. Surgical menopause; 3. Known hypersensitivity to the investigational drugs or their ingredients; 4. Patients with diseases as follows: Malignant tumor; hyperthyroidism, hypothyroidism, pheochromocytoma, uncontrolled diabetes; Obesity (body mass index greater than 30); neurasthenia, psychiatric disorders, migraine headache; Fungal or bacterial vaginal infections; organic cardio-cerebral vascular diseases, hypertension and low blood pressure does not control, thrombotic diseases; gastrointestinal diseases affecting drug absorption, hematopoietic system diseases, autoimmune system diseases; 5. Abnormal liver function or abnormal renal function; 6. Smoking at present or before, alcohol abuse; 7. The participants used the same treatment of traditional Chinese medicine in the previous 4 weeks. Use Estrogen or estrogen/progesterone drugs through vaginal or percutaneous or oral style in the previous 8 weeks. Take progesterone implants and a separate injection of estrogen therapy in the previous 3 months, Take estrogen pills or progesterone injection in the previous 6 months.

Design outcomes

Primary

Measure	Time frame
Menopause-specific quality-of-life (MENQOL);	—

Secondary

Measure	Time frame
Serum lipids (total cholesterol, HDL and LDL chole;FSH, E2;Hot flush frequency and severity;	—

Countries

China

Contacts

Public ContactXiumei Gao

gaoxiumei@tjutcm.edu.cn+86 13602020716

Outcome results

None listed

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