Effectiveness and Safety of Bushen Culuan Decoction for Anovulatory Infertility

Summary

This study is to evaluate the effectiveness and safety of Bushen Culuan Decoction in the treatment of anovulatory infertility, including anovulatory abnormal uterine bleeding, polycystic ovarian syndrome, hyperprolactinemia, luteinized unruptured follicle syndrome, corpus luteum insufficiency and ovarian insufficiency, through a randomised, double-blinded, double-dummy, parallel positive controlled, adaptive multicenter clinical trial.

Conditions

• Anovulatory Infertility
• Abnormal Uterine Bleeding-Ovulatory Disorders
• Polycystic Ovarian Syndrome
• Hyperprolactinemia
• Luteinized Unruptured Follicle Syndrome
• Corpus Luteum Insufficiency
• Ovarian Insufficiency

Interventions

DRUG

experimental group: Bushen Culuan Decoction and Clomiphene Citrate Tablets placebo

the same as group description including dosage, frequency and duration

DRUG

control group: Clomiphene Citrate Tablets and Bushen Culuan Decoction placebo

the same as group description including dosage, frequency and duration

Sponsors & Collaborators

• Dongzhimen Hospital, Beijing

  collaborator OTHER

• Beijing Obstetrics and Gynecology Hospital

  collaborator OTHER

• Beijing Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Beijing First Hospital of integrated Chinese and Western Medicine

  collaborator OTHER

• Beijing Fengtai Hospital of Integrated Traditional and Western Medicine

  collaborator UNKNOWN

• Xiyuan Hospital of China Academy of Chinese Medical Sciences

  lead OTHER

Principal Investigators

• Kun Ma, Dr. · Xiyuan Hospital of China Academy of Chinese Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-02-01

Primary Completion

2020-03-30

Completion

2020-08-31