Effectiveness and Safety of Bushen Culuan Decoction for Anovulatory Infertility
1 other identifier
interventional
528
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2018
CompletedFirst Posted
Study publicly available on registry
October 17, 2018
CompletedStudy Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedJanuary 10, 2019
August 1, 2018
1.2 years
October 9, 2018
January 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pregnancy Rate
Within 12 menstrual cycles from the first time that patient taking medicines. (Each cycle is 28 days)
Secondary Outcomes (15)
Ovulation Rate
At every ovulation phase (about day14 in a period cycle) within 3 or 6 menstrual cycles from the first time that patient taking medicines. (Each cycle is 28 days)
Basal Body Temperature
At every morning within 3 or 6 menstrual cycles from the first time that patient taking medicines to the end of the treatment. (Each cycle is 28 days)
Endocrine Hormone
At the early follicle phase (day 3 in a period cycle) before the 1st cycle of the treatment and at the 7th cycle of the treatment. (Each cycle is 28 days)
Inhibin B
At the early follicle phase (day 3 in a period cycle) before the 1st cycle of the treatment and at the 7th cycle of the treatment. (Each cycle is 28 days)
Anti-Mullerian Hormone (AMH)
At the early follicle phase (day 3 in a period cycle) before the 1st cycle of the treatment and at the 7th cycle of the treatment. (Each cycle is 28 days)
- +10 more secondary outcomes
Study Arms (2)
experimental group
EXPERIMENTALIntervention, dosage and frequency: drug: Bushen Culuan Decoction 13g tid and Clomiphene Citrate Tablets placebo 50mg qd; Dosage form: Bushen Culuan Decoction is dissolved medicine and Clomiphene Citrate Tablets placebo is tablets; Duration: the medicine will be taken from 5th day of a menstrual cycle, Bushen Culuan Decoction is taken for 14 days while Clomiphene Citrate Tablets placebo being taken for 5 days. Then patients stop taking the medicine until the 5th day of next menstrual cycle. If the patient doesn't have a regular menstrual cycle, the medicine will be taken from 5th day from vaginal bleeding caused by taking progesterone. Each treatment cycle contains 3 menstrual cycle. If the patient regains normal ovulation at the end of the first treatment cycle, she will reach the end of the whole treatment, and if not she will start the second treatment cycle. All treatment will be terminated after 2 treatment cycles.
control group
ACTIVE COMPARATORIntervention, dosage and frequency: drug: Clomiphene Citrate Tablets 50mg qd and Bushen Culuan Decoction placebo 13g tid; Dosage form: Clomiphene Citrate Tablets is tablet and Bushen Culuan Decoction placebo is dissolved medicine; Duration: the medicine will be taken from 5th day of a menstrual cycle, Clomiphene is taken for 5 days while Bushen Culuan Decoction placebo being taken for 14 days while. Then patients stop taking the medicine until the 5th day of next menstrual cycle. If the patient doesn't have a regular menstrual cycle, the medicine will be taken from 5th day from vaginal bleeding caused by taking progesterone. Each treatment cycle contains 3 menstrual cycle. If the patient regains normal ovulation at the end of the first treatment cycle, she will reach the end of the whole treatment, and if not she will start the second treatment cycle. All treatment will be terminated after 2 treatment cycles.
Interventions
the same as group description including dosage, frequency and duration
the same as group description including dosage, frequency and duration
Eligibility Criteria
You may qualify if:
- Aged 21\~40 years old;
- Diagnosed with infertility;
- Diagnosed with one of below diseases: anovulatory abnormal uterine bleeding, polycystic ovarian syndrome, hyperprolactinemia, luteinized unruptured follicle syndrome, corpus luteum insufficiency and ovarian insufficiency,
- Diagnosed with TCM syndrome of kidney deficiency and blood stasis syndrome;
- Patients who has normal sexual intercourse during treatment;
- Voluntary to sign the informed consent.
You may not qualify if:
- Infertility due to congenital physiological defect or malformation;
- Infertility due to hereditary factors；
- Infertility due to oviduct defect, immune factors, uterine fibroid, adenomyosis, endometriosis or hypoplasia of uterus；
- Spouse has reproductive defects；
- Severe abnormity of cardiovascular system, liver function, kidney function or hemopoietic system；
- Allergy to experimental drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xiyuan Hospital of China Academy of Chinese Medical Scienceslead
- Dongzhimen Hospital, Beijingcollaborator
- Beijing Obstetrics and Gynecology Hospitalcollaborator
- Beijing Hospital of Traditional Chinese Medicinecollaborator
- Beijing First Hospital of integrated Chinese and Western Medicinecollaborator
- Beijing Fengtai Hospital of Integrated Traditional and Western Medicinecollaborator
Related Publications (1)
Ma K, Shi Y, He J, Teng X, Wang R, Wang G, Yu Y, Chen Y, Gong L, Yuan Y, Zhang H, Yuan B, Zhang C. The effect of Bushen Culuan Decoction on anovulatory infertile women among 6 different diseases: a study protocol for a randomized, double-blinded, positively controlled, adaptive multicenter clinical trial. Trials. 2022 Jul 8;23(1):563. doi: 10.1186/s13063-022-06289-7.
PMID: 35804385DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kun Ma, Dr.
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2018
First Posted
October 17, 2018
Study Start
February 1, 2019
Primary Completion
March 30, 2020
Study Completion
August 31, 2020
Last Updated
January 10, 2019
Record last verified: 2018-08