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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Препарат 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.

Первичные конечные точки

• The percentage of subjects' mammary nucleus minification or disappearance at the third month. [Срок оценки: from baseline to the third month.]

Вторичные конечные точки (1)

• the change in bone age／the change in chronological age after six months [Срок оценки: from baseline to the sixth month]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Children's Hospital of Fudan university — Шанхай
• Children's Hospital of Fudan University — Шанхай

Идентификаторы

NCT: NCT06510764 · 23Y11921100

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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