CClinicalTrials.gg
RecruitingNCT06332742Updated Apr 4, 2024

Real-world Evaluation of Qingxin Zishen Decoction on Ovarian Reserve Function Clinical Efficacy in Patients With Decreased

An observational study in Decreased Ovarian Reserve, sponsored by Yun Chen. Recruiting at 1 site in China. Open to female participants aged 25 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-04.

Sponsored by Yun Chen · Observational

From the registry’s dates

  • Started Nov 2023; still recruiting 2 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
178
Ages
25 Years to 45 Years
Sex
Female
01

Study summary

A prospective cohort study evaluated the clinical efficacy of Qingxin Zishen Decoction

02

Conditions studied

  • Decreased Ovarian Reserve
03

In context

Lead sponsor

Yun Chen is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

  1. Those who meet the diagnostic criteria for hypoovarian reserve disease and the TCM syndrome differentiation criteria for heart and kidney disharmony.
  2. Aged between 25 and 45 years old, female.
  3. Informed consent and voluntary participation.
  4. The process of obtaining informed consent should comply with GCP regulations.

Eligibility criteria

1.AMH AMH \<1.1ng/ml 2.AFC: AFC \<5\~7 ovaries on both sides 3.Basic FSH: Basal FSH for two consecutive menstrual cycles ≥10 IU/L 4.Aged between 25 and 45 years old, female.

  1. Those with reduced ovarian function caused by ovarian or uterine surgery, radiotherapy and chemotherapy;
  2. Liver function (AST or ALT) and renal function (BUN or Ccr) are greater than 2 times the normal value;
  3. Patients with a history of mental illness or legal disability
  4. Those who have used endocrine-affecting drugs within 3 months before the study, estrogen, progesterone or related compound preparations, oral contraceptive pills, Chinese medicines or Chinese patent medicines related to the treatment of premature ovarian failure. Our hospital's preparations include Wu Turtle Rejuvenation Oral Liquid and Kuntai Capsules.
  5. Patients with unexplained irregular vaginal bleeding
  6. Patients who are participating in clinical trials of other drugs
  7. For women who want to have children, those whose spouse's semen test fails to meet the standard will be excluded.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
178 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • Exposome group

    5g lotus seed heart, 3g coptis, 15g uncaria, 15g fried jujube kernel, 10g dried rehmannia glutinosa, 9g dogwood meat, 10g salvia miltiorrhiza, 30g floating wheat. 1 dose per day, decocted in water twice, 200ml each time, taken warmly after breakfast and dinner

  • Non-exposed group

    All patients who met the inclusion criteria and did not use Qingxin Zishen Decoction.

06

What researchers measure

Primary outcomes

  1. Traditional Chinese medicine syndrome score

    Traditional Chinese medicine syndrome score

    Time frame: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment

  2. serum sex hormone levels

    SHBG stands for sex hormone binding globulin. It's a protein made mostly in your liver. It binds (attaches) to sex hormones in your blood.

    Time frame: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment

  3. serum AMH levels

    An AMH test measures levels of anti-mullerian hormone, which corresponds to a person's egg count.

    Time frame: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment

  4. transluminal ultrasound evaluation of ovarian antral follicles and other parameters (AFC)

    Antral follicle count is rightly done on day 3 of the cycle by a Trans vaginal ultrasound. Initially the ovarian volume of both the ovaries is calculated.

    Time frame: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment

Secondary outcomes

  1. Seven items of thyroid function

    The thyroid gland produces hormones that regulate the body's metabolic rate, growth and development. It plays a role in controlling heart, muscle and digestive function, brain development and bone maintenance.

    Time frame: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment

  2. natural pregnancy rate

    A woman in her early to mid-20s has a 25-30% chance of getting pregnant every month. Fertility generally starts to slowly decline when a woman is in her early 30s, and after the age of 35 the decline speeds up. By age 40, the chance of getting pregnant in any monthly cycle is around 5%.

    Time frame: Keep truthful case records and medication records for patient during the initial diagnosis, 3rd month, 6th month and 12th month of treatment

07

Study locations

1 of 1 sites recruiting
  • Jiangsu Provincial Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Chinese Medicine
    Nanjing, Jiangsu 210023, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06332742
Lead sponsor
Yun Chen
Responsible party
Yun Chen (chief physician, Jiangsu Province Hospital of Traditional Chinese Medicine) — Sponsor-investigator
First posted
Mar 27, 2024
Start date
Nov 1, 2023
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Apr 4, 2024

Study contacts

Chen Yun
Contact
66teoyq@gmail.com
8613675167221
TEO YONG QING
Contact
66teoyq@gmail.com
8613809008363

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion