NCT06510764

A Trial of Chinese Traditional Medicine Combining With Intradermal Acupuncture for Treating Precocious Puberty

A Randomized Controlled Trial of Ziyin-Xiehuo Chinese Medicine Herbs Combined With Intradermal Acupuncture for the Treatment of Girl's Idiopathic Precocious Puberty With Yin Deficiency and Fire Hyperactivity

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: Female
• Age: 4 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Precocious Puberty
• Treatment
• Alternative Medicine
• Acupuncture

Interventions

Type	Name	Description
OTHER	intradermal needles	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.
DRUG	Ziyinxiehuo Granules of traditional Chinese Medicine	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.

Timeline

• Start date: 2024-09-15
• Primary completion: 2027-07-01
• Completion: 2027-07-01
• First posted: 2024-07-19
• Last updated: 2026-03-16

Locations

2 sites across 1 country: China