A Phase 3 interventional study of intradermal needles and Ziyinxiehuo Granules of traditional Chinese Medicine in Precocious Puberty, Treatment and Alternative Medicine, sponsored by Children's Hospital of Fudan University. Recruiting at 2 sites in China. Open to female participants aged 4 Years to 9 Years. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Children's Hospital of Fudan University · Phase 3, Interventional, and Treatment
A randomized controlled study will be conducted to evaluate the therapeutic effect of traditional Chinese medicine and acupoints stimulation on children with idiopathic precocious puberty.
Traditional Chinese medicine is effective for precocious puberty which is mild or moderate, but not effective for the one that is severe and rapidly progressing. Acupuncture can effectively regulate sex hormone levels and ovarian function, promote ovulation, and have therapeutic effect for polycystic ovary syndrome and irregular menstruation. Studies have shown that acupuncture and auricular point compression stimulation is effective for premature thelarche, yet there are few studies on idiopathic precocious puberty. Clinical evidence is still needed to support whether acupuncture point stimulation combined with traditional Chinese Medicine herbs can enhance the effect and prevent the progression into severe or rapidly progressing precocious puberty, hence the study is to be carried out.
75 studies on the registry are indexed under Puberty, Precocious; 18 are open to participants now.
This study's planned enrollment of 170 is above the median of 64 across 47 interventional studies indexed under Puberty, Precocious.
Browse Puberty, Precocious studies →Children's Hospital of Fudan University is the lead sponsor of 268 studies on the registry; 95 are open to participants now.
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Exclusion Criteria:
Subjects in this group will be treated with traditional Chinese medicine and intradermal acupuncture point stimulation for 6 months.
Other: intradermal needles · Drug: Ziyinxiehuo Granules of traditional Chinese Medicine
Subjects in this group will be treated withTraditional Chinese Medicine for 6 months.
Drug: Ziyinxiehuo Granules of traditional Chinese Medicine
Disposable intradermal needles will be used for acupoint stimulation and Tai Chong, Taixi, Sanyinjiao, Hegu as well as Yanglingquan are chosen for acupuncture point. Acupuncture point pressure will last for 10 minutes each time, three times per day, and the intradermal needles will be changed every 2 days.
Ziyinxiehuo Granules of traditional Chinese Medicine which includes shengdi 15g, xuanshen 9g, zexie 9g, zhimu9g, huangbai 9g, zhiguiban 9g, maiya 15g, tiandong 9g, zhigancao 9g,and will be administered after dissolved, 1package every time, 2 times per day after a meal.
Also known as: traditional Chinese Medicine for nourishing Yin and purging fire
The percentage of subjects' mammary nucleus minification or disappearance at the third month.
The diameters of mammary nucleus will be measured with rulers along the median line of the breast at baseline,the third month and the sixth month. The subject numbers of mammary nucleus minification or disappearance at third month will be recorded. The percentage=the subject numbers of mammary nucleus minification or disappearance /total subject numbers in this group ×100%.
Time frame: from baseline to the third month.
the change in bone age／the change in chronological age after six months
The bone age will be measured with X-ray and evaluated with G-P Atlas method at baseline and the sixth month. the change in bone age= bone age after six months-bone age at baseline, the change in chronological age is six months.
Time frame: from baseline to the sixth month
Plan to share: No
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