Efficacy of Acupuncture Combined With Moving Cupping and Ear Point Tapping for Moderate and Severe Acne Vulgaris: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- IGA success rate
研究概览
简要总结
This trial is designed to evaluate the efficacy of different frequencies in treating the moderate and severe acne vulgaris using acupuncture combined with moving cupping and ear point tapping.
详细描述
Background: Acne vulgaris is a common skin disease, especially in adolescents and young adults. Acne affects approximately 85% of teenagers, but can occur in most age groups and can persist into adulthood. There is no mortality associated with acne, but there is often significant physical and psychological morbidity. Acupuncture combined with moving cupping and ear point tapping may effectively relieve the skin lesions, but the evidence is limited. Also, young patients usually have no time to see the doctor frequently, thus it's necessary to figure out a better frequency of treating.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as acne vulgaris.
- •GAGS score between 19 and 38 points.
- •Age of 15 to 35 years.
排除标准
- •Other types of acne: acne conglobate, acne fulminans，acne medicamentosa, premenstrual acne，cosmetic acne and trade acne.
- •Presence of any other systemic disease that could affect the acne severity by its presence, such as polycystic ovarian syndrome, or thyroid diseases, or atypical congenital adrenal hyperplasia；or by any medication prescribed for the treatment of the systemic diseases.
- •- Use of any topical acne treatment or systemic antibiotics or traditional Chinese medicine within 2 weeks before study initiation. Use of a systemic retinoid within 9 months before study initiation. Use of a systemic steroid within 9 months before study initiation. Presence of any change in the use of oral contraceptive pills or anti-inflammatory drugs within 3 months before study initiation.
- •Presence of any other skin disease that could interfere with the assessment of the acne, such as folliculitis or rosacea.
- •Presence of severe heart, liver, kidney or hematopoietic system diseases, as well as severe malnutrition.
- •Pregnancy or lactation.
- •Recent use of this research scheme within 4 weeks before study initiation.
研究组 & 干预措施
3 times per week therapeutic frequency
1.Acupuncture: GV20, LU5, LI11, LI4,GV14,BL13, ST2, BL2,ST7,ST6 and ashi point on the face.
- Huatuo Brand needle (0.20*13mm) will be used for GV14, BL13, ST2, BL2, ST7, ST6 and ashi point on the face. Huatuo Brand needle (0.3*40mm) will be used for GV20, LU5, LI11 and LI4.
2.Moving capping: Du Meridian (from GV14 to GV3) as well as the first (from BL11 to BL28) and second (from BL41 to BL53) side lines of the Urinary Bladder Meridian of Foot-Taiyang.
- Guoyiyan Brand cupping jar (size 4) will be used. 3.Ear point tapping: Lung (CO14), Heart (CO15), Stomach (CO4), Neifenmi (CO18), Pizhixia (AT4).
- Huatuo Brand, made by the seed of Vaccaria segetalis ( Neck.)Garcke.
干预措施: 3 times per week therapeutic frequency (Procedure)
1 time per week therapeutic frequency
The acupoints and treating procedures will be the same as the 3 times per week group. Only treating frequency is different. The treating frequency is 1 time per week.
- Acupuncture: GV20, LU5, LI11, LI4,GV14,BL13, ST2, BL2,ST7,ST6 and ashi point on the face.
- Moving capping: Du Meridian (from GV14 to GV3) as well as the first (from BL11 to BL28) and second (from BL41 to BL53) side lines of the Urinary Bladder Meridian of Foot-Taiyang.
- Ear point tapping: Lung (CO14), Heart (CO15), Stomach (CO4), Neifenmi (CO18), Pizhixia (AT4).
- Use the seed of Vaccaria segetalis ( Neck.)Garcke.
干预措施: 1 time per week therapeutic frequency (Procedure)
结局指标
主要结局
IGA success rate
时间窗: Baseline, week 1-6
The proportion of subjects who achieved at least a two-point reduction from baseline to week 6 in IGA(Investigator's Global Assessment, scale from 0 to 5) score
次要结局
- The change of the Visual Analogue Scale (VAS) for facial lesion pain from baseline.(Baseline, week 6, week 18, week 30)
- The change of the Skindex-16 dermatologic survey score from baseline.(Baseline, week 6, week 18, week 30)
- The change of IGA (Investigator's Global Assessment) score from baseline(Baseline, week 6, week 18, week 30)
- The change of the Visual Analogue Scale (VAS) for facial pruritus from baseline(Baseline, week 6, week 18, week 30)
- The change of the Total Lesion Count (TLC) on the face from baseline.(Baseline, week 6, week 18, week 30)
- The change of the Inflammatory Lesions (IN) on the face from baseline.(Baseline, week 6, week 18, week 30)
研究者
Chang Xie
Postgraduate student of Beijing University of Chinese Medicine & Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Guang'anmen Hospital of China Academy of Chinese Medical Sciences