Effectiveness and Safety of Bushen Culuan Decoction for Anovulatory Infertility

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Brief Title

Effectiveness and Safety of Bushen Culuan Decoction for Anovulatory Infertility

Official Title

Effectiveness and Safety of Bushen Culuan Decoction for Anovulatory Infertility:A Clinical Research of "Same Treatment for Different Diseases"

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.
    

Detailed Description

      Anovulation is one of the main causes of female infertility. Anovulatory infertility account
      for a proportion of 25-30% in whole female infertility.

      In western medicine, hormone induced ovulation and assisted reproduction technology are two
      main ways to solve the problem and Clomiphene citrate is the first-line medication in
      ovulation induction. There are many side effects being reported in the treatment with modern
      medicine technique such as ovarian hyperstimulation syndrome, complication with uteroscope
      and puncture egg retrieval, low pregnancy rate with high ovulation rate, potential cancer
      occuring risk and offspring healthy risk.

      Bushen Culuan Decoction is a traditional Chinese medicine recipe with 10 Chinese herbs
      including Tusizi, Yinyanghuo, Xianmao, Xuduan, Gouqizi, Nvzhenzi, Zelan, Shengpuhuang,
      Xiangfu and Chuanshanlong. Previous laboratory and exploratory clinical researches have
      proved Bushen Culuan Decoction had an exactly efficacy in treating anovulatory infertility
      safely.

      In the first stage, the primary sample size In the study is 528. Half patients will receive
      Bushen Culuan Decoction and clomiphene citrate placebo, while the other half will receive
      clomiphene citrate tablets and Bushen Culuan Decoction placebo. When 1/3 of 528 patients
      complete the treatment, we will analysis the treatment efficacy of 6 diseases separately, and
      find which of them could be the target diseases of Bushen Culuan Decoction. Then we will
      modify the sample size depending on the result in first stage, and the research will only be
      processed in the target diseases being chosen. In the next stage, half patients will receive
      Bushen Culuan Decoction and clomiphene citrate placebo, while the other half will receive
      clomiphene citrate tablets and Bushen Culuan Decoction placebo.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Pregnancy Rate

Secondary Outcome

 Ovulation Rate

Condition

Anovulatory Infertility

Intervention

experimental group: Bushen Culuan Decoction and Clomiphene Citrate Tablets placebo

Study Arms / Comparison Groups

 experimental group
Description:  Intervention, 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

528

Start Date

February 1, 2019

Completion Date

August 31, 2020

Primary Completion Date

March 30, 2020

Eligibility Criteria

        Inclusion Criteria:

          1. Aged 21~40 years old;

          2. Diagnosed with infertility;

          3. Diagnosed with one of below diseases: anovulatory abnormal uterine bleeding,
             polycystic ovarian syndrome, hyperprolactinemia, luteinized unruptured follicle
             syndrome, corpus luteum insufficiency and ovarian insufficiency,

          4. Diagnosed with TCM syndrome of kidney deficiency and blood stasis syndrome;

          5. Patients who has normal sexual intercourse during treatment;

          6. Voluntary to sign the informed consent.

        Exclusion Criteria:

          1. Infertility due to congenital physiological defect or malformation;

          2. Infertility due to hereditary factors;

          3. Infertility due to oviduct defect, immune factors, uterine fibroid, adenomyosis,
             endometriosis or hypoplasia of uterus;

          4. Spouse has reproductive defects;

          5. Severe abnormity of cardiovascular system, liver function, kidney function or
             hemopoietic system;

          6. Allergy to experimental drugs
      

Gender

Female

Ages

21 Years - 40 Years

Accepts Healthy Volunteers

No

Contacts

Kun Ma, Dr., 86-010-64089750, [email protected]



Administrative Informations


NCT ID

NCT03709849

Organization ID

Z171100001017104


Responsible Party

Sponsor

Study Sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Collaborators

 Dongzhimen Hospital, Beijing

Study Sponsor

Kun Ma, Dr., Principal Investigator, Xiyuan Hospital of China Academy of Chinese Medical Sciences


Verification Date

August 2018