Observation on Obesity Undergoing XOWI

NCT05122936 | Enrolling By Invitation

• 1 other identifier: SHMHTCM
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Traditional Chinese Medicine

Keywords

Obesity; Traditional Chinese medicine; SRXPY-based Obesity Wellness Intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Percentage of participants who achieve ≥10% body weight reduction

  2021-2027

• Percentage of participants who achieve ≥15% body weight reduction

  2021-2027

• Change in waist circumference

  2021-2027

• Change in glycosylated hemoglobin A-1c(Hba1c)

  2021-2027

• Change in fasting blood glucose

  2021-2027

Study Arms (1)

XOWI Group

Obesity Cohort undergoing XRXPY-based Obesity Wellness Intervention

Combination Product: XRXPY-based Obesity Wellness Intervention(SOWI)

Interventions

XRXPY-based Obesity Wellness Intervention(SOWI) COMBINATION_PRODUCT

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.

XOWI Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Feng Tao: lead

Study Sites (1)

Shanghai Municipal Hospital of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200071, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, urine, feces, et al

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Feng Tao

  Shanghai Municipal Hospital of Traditional Chinese Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Department of Endocrinology

Study Record Dates

• First Submitted: October 24, 2021
• First Posted: November 17, 2021
• Study Start: November 30, 2021
• Primary Completion (Estimated): November 14, 2026
• Study Completion (Estimated): November 14, 2027
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)