Observation on Obesity Undergoing XOWI

The Observation Study on Obesity Cohort Undergoing XRXPY-based Obesity Wellness Intervention

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Obesity; Traditional Chinese Medicine
• Intervention / Treatment: Combination product: XRXPY-based Obesity Wellness Intervention(SOWI)

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Feng Tao; Phone Number: +86(021)56639828; Email: taofeng@shutcm.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200071
      • Shanghai Municipal Hospital of Traditional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

XOWI Group; Obesity Cohort undergoing XRXPY-based Obesity Wellness Intervention

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-patient clinic, phone call or WeChat.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percent Change in Body Weight	Measuring body weight at the required time point	2021-2027
Percentage of Participants who Achieve ≥5% Body Weight Reduction	Measuring body weight at the required time point	2021-2027

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants who achieve ≥10% body weight reduction	Measuring body weight at the required time point	2021-2027
Percentage of participants who achieve ≥15% body weight reduction	Measuring body weight at the required time point	2021-2027
Change in waist circumference	Measuring waist circumference at the required time point	2021-2027
Change in glycosylated hemoglobin A-1c(Hba1c)	Measuring Hba1c at the required time point	2021-2027
Change in fasting blood glucose	Measuring fasting blood glucose at the required time point	2021-2027
Change in Three-Factor eating questionnaire(TFEQ-R21)	Investigating TFEQ-R21 at the required time point	2021-2027
Change in food craving questionnaire-trait(FCQ-T)	Investigating FCQ-T at the required time point	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).	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).	2021-2027
Change in cholecystokinin(CCK)	Measuring CCK in serum at the required time point	2021-2027
Change in bile acid	Measuring bile acid in serum and feces at the required time point	2021-2027
Change in peptide YY(PYY)	Measuring PYY in serum at the required time point	2021-2027
Change in ghrelin(GHRL)	Measuring GHRL in serum at the required time point	2021-2027

Collaborators and Investigators

• Sponsor: Feng Tao
• Investigators: Study Director: Feng Tao, Shanghai Municipal Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Estimated): November 14, 2026
• Study Completion (Estimated): November 14, 2027

Study Registration Dates

• First Submitted: October 24, 2021
• First Submitted That Met QC Criteria: November 7, 2021
• First Posted (Actual): November 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Traditional Chinese medicine; SRXPY-based Obesity Wellness Intervention
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: SHMHTCM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data materials will publish articles

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No