China Cimicifuga Trial of Climacteric Complaint Control (CCCCC)

Luye Pharma Group

Status and phase: Unknown; Phase 4

Conditions: Climacteric Symptoms

Treatments: Drug: placebo; Drug: an extract of Cimicifuga Foetida L.

Study type: Interventional

Funder types: Industry

Identifiers

NCT00622986

XMT-5Cs-002-2007

Details and patient eligibility

About

This study is designed to determine whether an extract of Cimicifuga Foetida L. is safe and efficacious to relieve the climacteric symptoms of Chinese women

Full description

Extracts of Cimicifuga Racemosa (black cohosh) have been widely used in North America and Europe for decades for the treatment of menopause related problems, either as nutritional supplements or as pharmaceutical products. Previous clinical trials had shown that an extract of Cimicifuga Foetida L.(Ximingting, Luyepharm), which was standardized to have similar components of an extract of Cimicifuga Racemosa, was safe and efficacious to relieve the climacteric symptoms and signs in Chinese women who were recruited according to criteria categorized by theory of Traditional Chinese Medicine.We are interested to know whether it may have the same efficacy and safety profiles when judged with method and standard commonly accepted in western medicine.

Enrollment: 288 estimated patients

Sex: Female

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Having climacteric symptoms with hot flushes >= 3 time per day
• Score of Kupperman Index at baseline >= 20
• In addition to these criteria, women who had menopause longer than 2 months but less than 12 months, with FSH > 15U/L were enrolled into the perimenopausal group. Women having menopause longer than 12 months but less than 5 years, with FSH >= 40U/L and E2 <= 30pg/ml, were assigned into early staged postmenopausal group.

Exclusion criteria

• Having history of hysterectomy
• Having HRT within 6 weeks
• Having other drugs or nutritional supplements of relieving climacteric symptoms within one week
• Having psychological counseling within one week
• Having medical history of estrogen-dependent tumors
• The result of pap smear exam at stage III and above
• Having an uterine leiomyoma lager than 4 cm
• The endometrial thickness lager than 0.5 cm
• Having abnormal cardiac, liver or kidney functions
• Having abnormal thyroid function
• Having hypertension, diabetes and coronary heart diseases that were not under control
• Pregnant or suspected pregnant woman
• Having severe mental disorders that inhibit to understand the research purpose
• Other conditions the investigators believed not suitable for enrollment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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288 participants in 4 patient groups, including a placebo group

A1

Experimental group

Description:

perimenopausal women

Treatment:

Drug: an extract of Cimicifuga Foetida L.

Drug: an extract of Cimicifuga Foetida L.

A2

Placebo Comparator group

Description:

perimenopausal women

Treatment:

Drug: placebo

Drug: placebo

B1

Experimental group

Description:

early staged postmenopausal women

Treatment:

Drug: an extract of Cimicifuga Foetida L.

Drug: an extract of Cimicifuga Foetida L.

B2

Placebo Comparator group

Description:

early staged postmenopausal women

Treatment:

Drug: placebo

Drug: placebo