Clinical trial NCT05122936: Observation on Obesity Undergoing XOWI
Official title: The Observation Study on Obesity Cohort Undergoing XRXPY-based Obesity Wellness Intervention
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Obesity
Traditional Chinese Medicine
Keywords: Obesity
Traditional Chinese medicine
SRXPY-based Obesity Wellness Intervention
Lead sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 500 Patients from the outpatient clinic of Shanghai Municipal Hospital of TCM will be enrolled in this study.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

·age ranged from 16-70 years old body mas index over 28kg/m2

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mean Percent Change in Body Weight
timeFrame: 2021-2027
measure: Percentage of Participants who Achieve ≥5% Body Weight Reduction
timeFrame: 2021-2027
Secondary outcomes:
measure: Percentage of participants who achieve ≥10% body weight reduction
timeFrame: 2021-2027
measure: Percentage of participants who achieve ≥15% body weight reduction
timeFrame: 2021-2027
measure: Change in waist circumference
timeFrame: 2021-2027
measure: Change in glycosylated hemoglobin A-1c(Hba1c)
timeFrame: 2021-2027
measure: Change in fasting blood glucose
timeFrame: 2021-2027
measure: Change in Three-Factor eating questionnaire(TFEQ-R21)
timeFrame: 2021-2027
measure: Change in food craving questionnaire-trait(FCQ-T)
timeFrame: 2021-2027
measure: Change in Impact of weight quality of life-lite(IWQOL-Lite)
timeFrame: 2021-2027
measure: Change in the medical outcomes study item short from health survey-short from(SF-36)
timeFrame: 2021-2027
measure: Change in cholecystokinin(CCK)
timeFrame: 2021-2027
measure: Change in bile acid
timeFrame: 2021-2027
measure: Change in peptide YY(PYY)
timeFrame: 2021-2027
measure: Change in ghrelin(GHRL)
timeFrame: 2021-2027
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Municipal Hospital of Traditional Chinese Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Municipal Hospital of Traditional Chinese Medicine
name: Feng Tao
role: STUDY_DIRECTOR
References: