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Real-world study on the efficacy and safety of Jiuwei chushi Granules in treating girls' precocious puberty

Real-world study on the efficacy and safety of Jiuwei chushi Granules in treating girls' precocious puberty

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300075014
Enrollment
Unknown
Registered
2023-08-23
Start date
2023-08-31
Completion date
Unknown
Last updated
2023-08-28

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

Conditions

precocious puberty

Interventions

Non-exposed group of Simple Premature Thelarche:NA
Exposure group of Simple Premature Thelarche (Only accept the intervention of Jiuwei chushi Granules):NA
Depherelin Group of Central Precocious Puberty (Only accept Depherelin intervention):NA
Jiuwei chushi Granules Group of Central Precocious Puberty (Only accept the intervention of Jiuwei chushi Granules):NA

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 (Simple Premature Thelarche or central precocious puberty); 2. The child meets the TCM diagnostic criteria of mainly Yin deficiency and fire and liver stagnation and fire; 3. Children are only girls, aged =4 years and =10 years old; 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 Simple 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 (mainly Yin deficiency and fire and liver stagnation 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

Secondary

MeasureTime frame
Staging of breast pain;Stages of pubic hair development;Staging of vaginal discharge;TCM syndrome score;Breast volume;Uterine length;Ovarian volume;Sex hormone six;growth rate;Bone age index;CBCL psychological scale score;IGF-1;IGFBP-3;routine blood test;Urine routine;Then routine;Liver and kidney function ;fasting blood-glucose;Thyroid function;VitD;electrocardiogram;

Primary

MeasureTime frame
Staging of breast development;Incidence rate of adverse events;

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