Observation on Obesity Undergoing XOWI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: XRXPY-based Obesity Wellness Intervention(SOWI).
- Who it may be relevant to
- Registry conditions: Obesity, Traditional Chinese Medicine. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Observation Study on Obesity Cohort Undergoing XRXPY-based Obesity Wellness Intervention
Overview
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.
Interventions
- Combination product XRXPY-based Obesity Wellness Intervention(SOWI)
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
Primary outcome measures
- Mean Percent Change in Body Weight [Time frame: 2021-2027]
- Percentage of Participants who Achieve ≥5% Body Weight Reduction [Time frame: 2021-2027]
Secondary outcome measures (12)
- Percentage of participants who achieve ≥10% body weight reduction [Time frame: 2021-2027]
- Percentage of participants who achieve ≥15% body weight reduction [Time frame: 2021-2027]
- Change in waist circumference [Time frame: 2021-2027]
- Change in glycosylated hemoglobin A-1c(Hba1c) [Time frame: 2021-2027]
- Change in fasting blood glucose [Time frame: 2021-2027]
- Change in Three-Factor eating questionnaire(TFEQ-R21) [Time frame: 2021-2027]
- Change in food craving questionnaire-trait(FCQ-T) [Time frame: 2021-2027]
- Change in Impact of weight quality of life-lite(IWQOL-Lite) [Time frame: 2021-2027]
- Change in the medical outcomes study item short from health survey-short from(SF-36) [Time frame: 2021-2027]
- Change in cholecystokinin(CCK) [Time frame: 2021-2027]
- Change in bile acid [Time frame: 2021-2027]
- Change in peptide YY(PYY) [Time frame: 2021-2027]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Shanghai Municipal Hospital of Traditional Chinese Medicine — Shanghai
Identifiers
NCT: NCT05122936 · SHMHTCM