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CompletedNCT07912008Updated Nov 3, 2026

Clinical Study on the Efficacy and Safety of Heyan® Kuntai Capsules in Alleviating Perimenopausal Symptoms Induced by GnRH-a

A Phase 4 interventional study of Kuntai Capsule and Placebo in Perimenopausal Symptom, sponsored by Xintian Pharmaceutical. Completed at 1 site in China. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Xintian Pharmaceutical · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Sep 2024, registered Oct 2026).
Updated Nov 3, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
162
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

The goal of this clinical trial is to learn if Kuntai capsule works to treat perimenopausal symptoms caused by GnRH-a in adults. It will also learn about the safety of Kuntai capsule.

02

Conditions studied

  • Perimenopausal Symptom

Keywords

  • Perimenopausal
  • GnRH-a
03

In context

Lead sponsor

Xintian Pharmaceutical is the lead sponsor of 8 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
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Women aged 18 to 45 years old who have not reached menopause;
  2. Patients diagnosed with endometriosis, uterine fibroids, uterine adenomyosis or any of these diseases after surgery, and who are scheduled to receive ≥ 3 courses of *GnRH-a treatment.
  3. Voluntary participants who agree to receive the treatment and sign the form.

Exclusion criteria

Exclusion Criteria:

  1. For non-surgical patients, AMH should be less than 0.5 ng/mL within 3 months before enrollment, and for surgical patients, it should be less than 0.5 ng/mL after surgery.
  2. should be ≥ 30 kg/m².
  3. Suspected or confirmed cases of gynecological such as breast cancer, ovarian cancer, endometrial cancer, etc.
  4. Within the past 2 months, have received treatment with drugs such as progestins, combined oral (COC), GnRH-a and its analogues, danazol, etc., or have placed an intrauterine device (IUD) such as Mirena.
  5. Within the past 2 weeks, have taken herbal or traditional Chinese medicine that affects the efficacy of this study, such as Lifemin, Dingkundan, Zixin Yutai Pill, etc.
  6. Have severe diseases of the cardiovascular, nervous, liver, kidney, hematopoietic system or other systems, as well as mental disorders or intellectual disabilities.
  7. (AST) or alanine aminotransferase (ALT) should be more than 1.5 times the reference range, or serum creatinine (Scr) should be more than the upper limit of the normal reference range.
  8. Are currently participating in or have participated in other clinical trials within the past 3 months before screening.
  9. Are allergic or intolerant to the drugs or known drugs in the study formula.
  10. Have a habit of smoking more than 10 cigarettes per day within the past 3 months before screening.
  11. Patients with deficient yang constitution, such as those with thin stools or nocturnal diarrhea.
  12. History of drug abuse, drug addiction or alcoholism.
  13. Other patients deemed unsuitable to participate in this study by the researchers.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
162 participants (actual)

Study arms

  • Experimental
    Kuntai capsule

    Drug: Kuntai Capsule

  • Placebo comparator
    placebo

    Drug: Placebo

Interventions

  • DrugKuntai Capsule

    The ingredients include rehmannia glutinosa, coptis chinensis, white peony root, scutellaria baicalensis, donkey-hide gelatin, and poria cocos.

  • DrugPlacebo

    The shape, color, smell and taste are all similar to Kuntai Capsules.

06

What researchers measure

Primary outcomes

  1. modified Kupperman Index

    Time frame: at 4,8,12 weeks

07

Study locations

1 site
  • Peking University People's Hospital
    Beijing, Beijing Municipality 61554, China
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07912008
Lead sponsor
Xintian Pharmaceutical
Responsible party
Sponsor
First posted
Nov 3, 2026
Start date
Sep 26, 2024
Primary completion
Feb 11, 2026
Completion
Feb 11, 2026
Last update
Nov 3, 2026

Oversight

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

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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