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
Location: See all (2) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 4
Maximum Age: 9
Healthy Volunteers: f
View:
• Girls are diagnosed as Idiopathic precocious puberty, and their age of onset ≤7.5years;
• Tanner stages of breast in female patients ≤ Tanner III stage, diameters of mammillary nucleus ≤ 3cm; •B-type ultrasonography: the volume of uterus≥ 3ml, the volume of ovary≥1.5ml, the diameter of follicle≥4mm;
• Bone age: compared the chronological age, the bone age is less than 1 year and the bone age \<10 years old;
• No GnRH analogs or Sex hormones were administrated in the past; and All above are needed at the same time.
Locations
Other Locations
China
Children's Hospital of Fudan university
RECRUITING
Shanghai
Children's Hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Han Xinghui, Master
1055952886@qq.com
021-64931219
Time Frame
Start Date: 2024-09-15
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 170
Treatments
Experimental: Traditional Chinese Medicine+acupuncture
Subjects in this group will be treated with traditional Chinese medicine and intradermal acupuncture point stimulation for 6 months.
Active_comparator: Traditional Chinese Medicine
Subjects in this group will be treated withTraditional Chinese Medicine for 6 months.
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital of Fudan University