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The study was terminated prematurely due to the inapplicability of the primary outcome measure
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Clinical Observation of Qingwei Huazhuo Decoction (Product: Jinsaiyu) in Improving Children With Precocious Puberty of Phlegm-Dampness Internal Accumulation Type
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | The intervention group is administered Qingwei Huazhuo Decoction therapy and diet and exercise education for a period of six months. |
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| Control group | Experimental | diet and exercise education |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qingwei Huazhuo Decoction: Mulberry leaf powder, lotus leaf powder, malt powder, hawthorn powder, Poria cocos powder, gardenia powder, dried tangerine peel powder, licorice powder, momordica grosvenor | Combination Product | On the basis of receiving dietary and exercise education, the pediatric patients were given the Qingwei Huazhuo Decoction orally. Composition:Mulberry Leaf Powder, Lotus Leaf Powder, Germinated Barley Powder, Hawthorn Powder, Poria Mushroom Powder, Cape Jasmine Fruit Powder, Tangerine Peel Powder, Licorice Root Powder, Monk Fruit Powder. Administration Method:Take one sachet each time, add 150ml of warm boiled water, stir well, and drink. Treatment Course:The first-stage course lasts for 12 weeks.For participants in the experimental group who have completed the first 12-week stage, they may continue to take the Qingwei Huazhuo Decoction orally for another 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| breast nucleus diameter | Measured by the attending physician using a straightedge | The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start. |
| Measure | Description | Time Frame |
|---|---|---|
| Bone age | Bone age is determined by radiologists in our hospital who take a posteroanterior radiograph of the left hand and judge the bone age according to the Greulich-Pyle (GP) atlas method. | The measurement times are before the start of the experiment and the 24th week after the start. |
| Traditional Chinese Medicine syndrome score |
| Measure | Description | Time Frame |
|---|---|---|
| Testosterone | Testosterone(nmol/L, detected from the blood) Blood samples are collected from all patients in the morning after an overnight fast. Hormone levels are measured using chemiluminescent immunoassay. | The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start. |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Fudan University | Shanghai | 201102 | China |
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| diet and exercise education | Behavioral | ① Dietary Education With reference to the Balanced Diet Pagoda for School-Age Children Aged 6-10 Years in the Chinese Dietary Guidelines for School-Age Children (2022), the children were required to record their daily diet and complete a dietary diary. ② Exercise Education Children were advised to accumulate at least 60 minutes of moderate-to-vigorous physical activity (MVPA) daily, mainly consisting of aerobic exercise. The specific requirements were as follows: 1.3-5 sessions of aerobic exercise per week; 2.2-3 sessions of resistance exercise per week; 3.Daily screen time limited to less than 2 hours. The parents were asked to record their children's daily completion of the above requirements. |
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According to the Guidelines for the Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Pediatric Precocious Puberty (2023 Edition) and clinical experience, the scoring criteria for traditional Chinese medicine (TCM) syndromes were screened and determined: each symptom was assigned a score: 0 for no symptom; 1 for mild; 2 for moderate; 3 for severe. The total score was obtained by summing the scores of all symptoms. |
| The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start. |
| PRL |
Prolactin(mIU/L, detected from the blood) Blood samples are collected from all patients in the morning after an overnight fast. Hormone levels are measured using chemiluminescent immunoassay. |
| The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start. |
| Estradiol | Estradiol(pmol/L, detected from the blood) Blood samples are collected from all patients in the morning after an overnight fast. Hormone levels are measured using chemiluminescent immunoassay. | The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start. |
| FSH | Follicle-Stimulating Hormone(U/L, detected from the blood) Blood samples are collected from all patients in the morning after an overnight fast. Hormone levels are measured using chemiluminescent immunoassay. | The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start. |
| LH | Luteinizing Hormone(U/L, detected from the blood) Blood samples are collected from all patients in the morning after an overnight fast. Hormone levels are measured using chemiluminescent immunoassay. | The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start. |
| Height | The height is measured and obtained by the physician. Place the mechanical height measuring device horizontally on a flat surface, against a wall, and calibrate the height measuring device reading. Instruct the examinee to stand barefoot on the base plate of the height measuring device, facing away from the pillar. When the doctor moves the height measuring device, he holds the handle of the height measuring device, moves horizontally, tries to keep the head upright, and keeps the body and limbs naturally straight. For hair knots and braids that are not convenient to measure height, they should be untied and headwear should be removed. The horizontal pressure plate should be in contact with the head, and the tightness should be moderate. The data is read in cm units and is accurate to 0.1. | The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start. |
| Weight | The weight is measured and obtained by the physician. Place the electronic scale flat on the ground, calibrate the scale reading, instruct the examinee to empty their bowels and bladder, wear light clothing and stand barefoot naturally in the center of the electronic scale pedal, keep the body stable, record the data, the unit is kg, and the value is accurate to 0.1. | The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start. |
| Waist-Hip Ratio | Use a flexible, non-elastic anthropometric tape (mm-scale) and have the subject stand upright (feet shoulder-width apart, arms relaxed, abdomen relaxed) in lightweight, form-fitting clothing. For waist circumference: Mark the midpoint between the costal arch's inferior margin and iliac crest's superior border (umbilicus as alternative if unclear). Wrap the tape horizontally here-level, skin-adherent, no subcutaneous compression. Record to 0.1 cm at end of normal expiration; average 2-3 readings. For hip circumference: Locate the gluteal region's widest transverse diameter (confirmed posteriorly/laterally). Wrap tape horizontally here (level, flat). Record to 0.1 cm; average 2-3 readings. Compute WHR as mean waist ÷ mean hip (decimal, e.g., 85.2 cm ÷ 102.5 cm ≈ 0.83). Trained personnel must conduct measurements to reduce inter-observer variation. | The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start. |
| Uterine volume | Uterine volume obtained through ultrasound measurement; The size and shape of the organs are measured by a professional ultrasound physician from our hospital. The volume is calculated using the formula: V=(π /6)*length*anteroposterior diameter*transverse diameter, with the unit being cubic centimeters (cm³). | The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start. |
| ovarian volume | Ovarian volume obtained through ultrasound measurement The size and shape of the organs are measured by a professional ultrasound physician from our hospital. The volume is calculated using the formula: V=(π /6)*length*anteroposterior diameter*transverse diameter, with the unit being cubic centimeters (cm³). | The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start. |
| follicle diameter | Follicle diameter obtained through ultrasound measurement The size and shape of the organs are measured by a professional ultrasound physician from our hospital. | The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start. |
| Breast Tanner staging | Breast Tanner staging (obtained by the physician through physical examination). The Tanner staging criteria and standard illustrations are used for definition. Some obese girls may find it difficult to distinguish between breast tissue and fat tissue, so we have all the subjects raise their arms and have professional doctors use visual and palpation methods to assess the breast development stage. | The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start. |
| HbA1c | Glycated Hemoglobin(detected from the blood). Blood samples are collected from all patients in the morning after an overnight fast. Levels are measured using chemiluminescent immunoassay. | The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start. |
| TC | Total Cholesterol, detected from the blood. Blood samples are collected from all patients in the morning after an overnight fast. Levels are measured using chemiluminescent immunoassay. | The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start. |
| TG | Triglycerides, detected from the blood. Blood samples are collected from all patients in the morning after an overnight fast. Levels are measured using chemiluminescent immunoassay. | The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start. |
| LDL-C | Low-Density Lipoprotein Cholesterol, detected from the blood. Blood samples are collected from all patients in the morning after an overnight fast. Levels are measured using chemiluminescent immunoassay. | The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start. |
| HDL-C | High-Density Lipoprotein Cholesterol, detected from the blood. Blood samples are collected from all patients in the morning after an overnight fast. Levels are measured using chemiluminescent immunoassay. | The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start. |
| ApoB | Apolipoprotein B, detected from the blood. Blood samples are collected from all patients in the morning after an overnight fast. Hormone levels are measured using chemiluminescent immunoassay. | The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start. |
| ID | Term |
|---|---|
| D011629 | Puberty, Precocious |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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