The Observation Study on Obesity Cohort Undergoing XRXPY-based Obesity Wellness Intervention
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Percentage of Participants who Achieve ≥5% Body Weight Reduction
研究概览
简要总结
Obesity becomes a worldwide chronic health problem, including China. Meta-analyses showed in recent years anti-obesity effects of Chinese herbal therapy (CHT) in overweight and obese patients. However, there are still few observational studies on its effect in patients undergoing CHT more than 6 months, or on its safety. This is a mono-centric, prospective study conducted at Shanghai Municipal Hospital of Traditional Chinese Medicine. Patients with body mass index ≥ 28 Kg/m2 and chartered by heat-dampness is consecutively recruited. All the patients will undergo an integrated SRXPY-based Obesity Wellness Intervention (lifestyle invention + XRXP granule). Patients will be instructed by Traditional Chinese Medicine(TCM) practitioner and nutritionist. They will be investigated every 3 months, until 2 years after enrollment. The study will test anti-obesity effect and safety of the integrated obesity wellness intervention, and test changes of appetite, health-related quality of life, bio markers as well.
详细描述
Obesity is a worldwide problem to public health, with a prevalence rate of 12.4% according to recent studies. It is associated with a series of chronic non-communicable diseases, including type 2 diabetes, cardiovascular diseases, non-alcoholic fatty liver, polycystic ovary syndrome, cancer, and so on. Many publications reported Chinese herbal therapy as an effective anti- obesity management. However, there are still few observational studies on its effect in patients undergoing Chinese herbal therapy more than 6 months, or on its safety.
This is a mono-centric, prospective study conducted at Shanghai Municipal Hospital of Traditional Chinese Medicine. Patients with body mass index ≥ 28 Kg/m2 will be consecutively recruited in out-patient clinic of the department of endocrinology or nutrition. Another important including criteria is that each subject is supposed to be chartered by heat-dampness pattern in TCM. Patients will undergo an integrated SRXPY-based obesity wellness intervention(SOWI). They will report weekly diet, daytime physical activities and sleeping time, by means of WeChat and Electrical bracelet. Meanwhile, TCM practitioner and nutritionist will be involved in helping them.
The integrated obesity wellness intervention is based on lifestyle invention and XRXP granule. XRXP granule is composed of several herbs, such as Huang Qin (Baical Skullcap Root), Zi Cao (Root of Sinkiang Arnebia), Hu Zhang (Rhizoma Polygoni cuspidata), Cang Shu (Atractylodis Rhizoma), He Ye (Lotus Leaf), etc. Some components have been found, which can ameliorate serum concentrations of glucagon-like peptide-1 by stimulating gut taste receptors in db/db mice. Also, XRXP granule showed anti-obesity effects (reduction of body weight, body mass index and waist circumstance) in a 12-week pilot study on obese patients.
In this observational study, patients will be investigated every 3 months, until 2 years after enrollment. We will not only test the effect and safety, but test changes of appetite, health- related quality of life, bio markers as well.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •·age ranged from 16-70 years old body mas index over 28kg/m2
排除标准
- •secondary cause of obesity such as hypothalamic obesity, cushing syndrome, and hypophysis dysfunction, etc.
- •pregnancy or lactation
- •significant dysfunction of heart, liver, kidney and systemic organs (NYHA Class III or IV; alanine aminotransferase(ALT) and / or aspartate aminotransferase(AST) ≥ 5 times the normal upper limit; glomerular filtration rate< 60(ml/min) or with malignant tumor
- •body weight fluctuated by more than 5 kg in the last 3 months with drug abuse or alcohol addiction
- •with serious mental and neurological disorders
- •blood pressure ≥ 180/110 mmHg, or malignant hypertension
- •organic and systemic diseases intolerant of herb
结局指标
主要结局
Percentage of Participants who Achieve ≥5% Body Weight Reduction
时间窗: 2021-2027
Measuring body weight at the required time point
Mean Percent Change in Body Weight
时间窗: 2021-2027
Measuring body weight at the required time point
次要结局
- Percentage of participants who achieve ≥10% body weight reduction(2021-2027)
- Change in fasting blood glucose(2021-2027)
- Change in food craving questionnaire-trait(FCQ-T)(2021-2027)
- Change in peptide YY(PYY)(2021-2027)
- Change in glycosylated hemoglobin A-1c(Hba1c)(2021-2027)
- Change in the medical outcomes study item short from health survey-short from(SF-36)(2021-2027)
- Change in cholecystokinin(CCK)(2021-2027)
- Percentage of participants who achieve ≥15% body weight reduction(2021-2027)
- Change in waist circumference(2021-2027)
- Change in bile acid(2021-2027)
- Change in Three-Factor eating questionnaire(TFEQ-R21)(2021-2027)
- Change in Impact of weight quality of life-lite(IWQOL-Lite)(2021-2027)
- Change in ghrelin(GHRL)(2021-2027)
研究者
Feng Tao
Director, Department of Endocrinology
Shanghai Municipal Hospital of Traditional Chinese Medicine