A Trial of Chinese Traditional Medicine Combining With Intradermal Acupuncture for Treating Precocious Puberty
NCT ID: NCT06510764
Last Updated: 2025-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
170 participants
INTERVENTIONAL
2024-09-15
2027-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Traditional Chinese Medicine+acupuncture
Subjects in this group will be treated with traditional Chinese medicine and intradermal acupuncture point stimulation for 6 months.
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.
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.
Traditional Chinese Medicine
Subjects in this group will be treated withTraditional Chinese Medicine for 6 months.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
4 Years
9 Years
FEMALE
No
Sponsors
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Children's Hospital of Fudan University
OTHER
Responsible Party
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Principal Investigators
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Sun Yanyan, Master
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Fudan University
Locations
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Children's Hospital of Fudan university
Shanghai, Shanghai Municipality, China
Children's Hospital of Fudan University
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23Y11921100
Identifier Type: -
Identifier Source: org_study_id
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