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

NCT06510764 | Recruiting Phase 3

• 1 other identifier: 23Y11921100
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Precocious Puberty; Treatment; Alternative Medicine; Acupuncture

Outcome Measures

Primary Outcomes (1)

• 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%.

  from baseline to the third month.

Secondary Outcomes (1)

• the change in bone age／the change in chronological age after six months

  from baseline to the sixth month

Study Arms (2)

Traditional Chinese Medicine+acupuncture

EXPERIMENTAL

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

Traditional Chinese Medicine

ACTIVE COMPARATOR

Subjects in this group will be treated withTraditional Chinese Medicine for 6 months.

Drug: Ziyinxiehuo Granules of traditional Chinese Medicine

Interventions

intradermal needles OTHER

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.

Traditional Chinese Medicine+acupuncture

Ziyinxiehuo Granules of traditional Chinese Medicine DRUG

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

Traditional Chinese Medicine; Traditional Chinese Medicine+acupuncture

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Precocity caused by the central nervous system organic diseases;
• Precocious precocity caused by congenital hypothyroidism, congenital adrenal hyperplasia, adrenal tumor and ovarian or testicular neoplasms as well as McCune-Albright syndrome, etc;
• Precocious precocity with a family history of diseases such as tumor, leukemia, diabetes, systemic lupus erythematous;
• Pseudo sexual precocity and partial precocious puberty.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (2)

Children's Hospital of Fudan university

Shanghai, Shanghai Municipality, 201102, China

RECRUITING

Children's Hospital of Fudan University

Shanghai, 201102, China

RECRUITING

MeSH Terms

Conditions

Puberty, Precocious

Interventions

Medicine, Chinese Traditional

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Medicine, East Asian Traditional; Medicine, Traditional; Complementary Therapies; Therapeutics

Study Officials

• Sun Yanyan, Master

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Han Xinghui, Master

CONTACT

021-64931219; 1055952886@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: September 15, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)