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.
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.
Study Type
OBSERVATIONAL
Enrollment
500
It is an integrated obesity wellness intervention, composing of lifestyle invention and Chinese herbal therapy (XRXP granule, twice daily, oral administration). XRXPY is made in accordance with standard procedures. Participants will be instructed by TCM practitioner and educated by nutritionist. They will perform diet self-report by WeChat, recording daytime physical active steps and all-day sleeping time by electric bracelet. All the participants will be followed every 2-4 weeks by means of out-patient clinic, phone call or WeChat.
Shanghai Municipal Hospital of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Mean Percent Change in Body Weight
Measuring body weight at the required time point
Time frame: 2021-2027
Percentage of Participants who Achieve ≥5% Body Weight Reduction
Measuring body weight at the required time point
Time frame: 2021-2027
Percentage of participants who achieve ≥10% body weight reduction
Measuring body weight at the required time point
Time frame: 2021-2027
Percentage of participants who achieve ≥15% body weight reduction
Measuring body weight at the required time point
Time frame: 2021-2027
Change in waist circumference
Measuring waist circumference at the required time point
Time frame: 2021-2027
Change in glycosylated hemoglobin A-1c(Hba1c)
Measuring Hba1c at the required time point
Time frame: 2021-2027
Change in fasting blood glucose
Measuring fasting blood glucose at the required time point
Time frame: 2021-2027
Change in Three-Factor eating questionnaire(TFEQ-R21)
Investigating TFEQ-R21 at the required time point
Time frame: 2021-2027
Change in food craving questionnaire-trait(FCQ-T)
Investigating FCQ-T at the required time point
Time frame: 2021-2027
Change in Impact of weight quality of life-lite(IWQOL-Lite)
Investigating IWQOL-Lite at the required time point,higher scores indicate better quality of life on the IWQOL-Lite(0-100).
Time frame: 2021-2027
Change in the medical outcomes study item short from health survey-short from(SF-36)
Investigating SF-36 at the required time point,higher scores indicate better quality of life on the SF-36(0-100).
Time frame: 2021-2027
Change in cholecystokinin(CCK)
Measuring CCK in serum at the required time point
Time frame: 2021-2027
Change in bile acid
Measuring bile acid in serum and feces at the required time point
Time frame: 2021-2027
Change in peptide YY(PYY)
Measuring PYY in serum at the required time point
Time frame: 2021-2027
Change in ghrelin(GHRL)
Measuring GHRL in serum at the required time point
Time frame: 2021-2027
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