Evidence map›Paper›PMID 39934764›Full record

ArticleBMC complementary medicine and therapies2025

Efficacy and safety of HYYK formula for residual follicle revival in premature ovarian insufficiency: a multicenter, randomized, double-blind, placebo-controlled trial protocol.

Yin Peng, Jian Liu, Yang Li, Guangning Nie, Fangping Cheng, Daning Feng, Qiaolin Du, Jian Huang, Hongyan Yang

Abstract readClinical Trial Protocol
In one paragraph

Article in BMC complementary medicine and therapies, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Yin PengThe Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, 510006, Guangdong Province, People's Republic of China.
Jian LiuDepartment of Gynecology, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, 510120, Guangdong Province, People's Republic of China.
Yang LiThe Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, 510006, Guangdong Province, People's Republic of China.
Guangning NieDepartment of Gynecology, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, 510120, Guangdong Province, People's Republic of China.
Fangping ChengDepartment of Gynecology, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, 510120, Guangdong Province, People's Republic of China.
Daning FengDepartment of Gynecology, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, 510120, Guangdong Province, People's Republic of China.
Qiaolin DuDepartment of Gynecology, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, 510120, Guangdong Province, People's Republic of China.
Jian HuangDepartment of Gynecology, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, 510120, Guangdong Province, People's Republic of China.
Hongyan YangDepartment of Gynecology, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, 510120, Guangdong Province, People's Republic of China. hongyanyang@gzucm.edu.cn.

Funding

Clinical Research Special Project Fund from Guangdong Provincial Hospital of Chinese Medicine YN10101912Guangdong Provincial Basic and Applied Research Fund Project 2022A1515220058Special Research Project for Traditional Chinese Medicine Science and Technology of Guangdong Provincial Hospital of Traditional Chinese Medicine YN2023ZH09the National Natural Science Foundation of China 82274568
6 · The paper itself

Abstract

backgroundPremature ovarian insufficiency (POI), a condition impacting women under 40, is rising globally, posing significant risks to fertility, bone health, and cardiovascular function. Conventional hormone replacement therapy (HRT) alleviates symptoms but fails to restore ovarian function. Our prior studies have demonstrated that the Huyang Yangkun (HYYK) formula effectively supports menstrual cycle frequency and alleviates menopause-related symptoms in POI patients. This study aims to evaluate the efficacy and safety of the HYYK formula, a traditional Chinese medicine (TCM) approach, in enhancing residual follicle activity in POI patients.

methodsThis multicenter, randomized, double-blind, placebo-controlled trial will enroll 102 women with POI, who will be randomly assigned to receive either the HYYK formula or a placebo for 24 weeks. Primary outcomes will be assessed through Hoogland and Skouby scores (indicative of residual follicle activity) and menstrual cycle regularity. Secondary outcomes include hormone levels (AMH, FSH, LH, E2), ovarian volume, antral follicle count, and clinical symptom scales, such as the Greene Scale and the Female Sexual Function Index. Safety assessments will involve routine physical exams and adverse event monitoring. DISCUSSION: This is the first multicenter, randomized, double-blind, placebo-controlled study to investigate the efficacy of TCM in stimulating residual follicle recovery in POI patients. The trial rigorously investigates the potential of the HYYK formula as a therapeutic alternative for POI, aiming to deliver high-quality evidence that supports the use of TCM in POI management. This study will concentrate on stimulating residual follicle development in POI patients, offering a viable approach to delaying ovarian decline and generating compelling clinical evidence.

trial registrationChinese Clinical Trials.gov ChiCTR2100049604 Registered on August 6, 2021 ( http://www.chictr.org.cn ).

Indexed as

Drugs, Chinese HerbalOvarian FolliclePrimary Ovarian InsufficiencyAdultDouble-Blind MethodFemaleHumansMedicine, Chinese TraditionalMulticenter Studies as TopicRandomized Controlled Trials as TopicYoung AdultDrugs, Chinese HerbalPremature ovarian insufficiency (POI)Randomized controlled trialResidual follicleTraditional Chinese medicine (TCM)

Identifiers

PMID39934764
PMCPMC11817039

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.