Skip to content

Real-world study on the efficacy and safety of Xiangcha Wenyu recipe in treating girls' precocious puberty

Real-world study on the efficacy and safety of Xiangcha Wenyu recipe in treating girls' precocious puberty

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2025001578
Enrollment
Unknown
Registered
2025-08-19
Start date
2025-08-23
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

precocious puberty

Interventions

Group of Premature Thelarche (only take Xiangcha Wenyu recipe):Xiangcha Wenyu recipe
Group of Central Precocious Puberty (only take Xiangcha Wenyu recipe):Xiangcha Wenyu recipe

Sponsors

Hubei Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
4 Years to 10 Years

Inclusion criteria

Inclusion criteria: (1) The child meets the diagnostic criteria of western medicine for precocious puberty (premature Thelarche or idiopathic central precocious puberty); (2) The child meets the diagnostic criteria of liver depression and fire, and needs to have any two accompanying symptoms or signs; (3) Children are only girls, aged =4 years and =10 years; (4) The child has not received any treatment before, which is consistent with the first diagnosis; (5) The children themselves and their legal guardians have informed consent and cooperated with this study.

Exclusion criteria

Exclusion criteria: (1) The child has menarche; (2) Peripheral precocious puberty; (3) Incomplete precocious puberty except Premature Thelarche; (4) Central precocious puberty caused by primary hypothyroidism; (5) Central precocious puberty caused by organic diseases of the central nervous system, such as hypothalamic and pituitary tumors, hamartoma, hydrocephalus and trauma; (6) TCM diagnosis of precocious puberty (liver depression and fire) and other syndromes; (7) Accompanied by serious diseases of heart, kidney, liver and hematopoietic system; (8) Those who are highly allergic or allergic to the drugs in this study; (9) Those who have recently participated in other clinical trials and affected the judgment of curative effect or have recently used sex hormone drugs or traditional Chinese medicine.

Design outcomes

Primary

MeasureTime frame
Reduction ratio of breast development (Premature Thelarche);Conversion ratio of central precocious puberty (Premature Thelarche);Delayed proportion of sexual development stages (central precocious puberty);Proportion of delayed bone age (central precocious puberty);Predicted as the proportion of height increase at the end of the year (central precocious puberty);Proportion of adverse events (Premature Thelarche, central precocious puberty);

Secondary

MeasureTime frame
Sex hormone six (Premature Thelarche, central precocious puberty);GnRH excitation test (Premature Thelarche, central precocious puberty);Uterine length (Premature Thelarche, central precocious puberty);Ovarian volume (Premature Thelarche, central precocious puberty);Follicle number (Premature Thelarche, central precocious puberty);Maximum diameter of follicle (Premature Thelarche, central precocious puberty);TCM syndrome score (Premature Thelarche, central precocious puberty);growth rate (Premature Thelarche, central precocious puberty);routine blood test (Premature Thelarche, central precocious puberty);Urine routine (Premature Thelarche, central precocious puberty);Then routine (Premature Thelarche, central precocious puberty);Liver and kidney function (Premature Thelarche, central precocious puberty);Thyroid function (Premature Thelarche, central precocious puberty);VitD (Premature Thelarche, central precocious puberty);electrocardiogram (Premature Thelarche, central precocious puberty);CBCL psychological assessment scale;Height standard deviation (HT-SDS);Insulin like growth factor -1 (IGF-1);Insulin Like Growth Factor Binding Protein 3 (IGFBP-3);

Countries

China

Contacts

Public ContactJIANZHONG LIU

Hubei Provincial Hospital of Traditional Chinese Medicine (Affiliated Hospital of Hubei University of Traditional Chinese Medicine)

Ljzwd@163.com+86 133 0717 3928

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026