Observation on Obesity Undergoing XOWI

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05122936
• Other study ID #: SHMHTCM
• Status: Enrolling by invitation
• Start date: November 30, 2021
• Est. completion date: November 14, 2027

Study information

• Verified date: March 2024
• Source: Shanghai Municipal Hospital of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: November 14, 2027
• Est. primary completion date: November 14, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Traditional Chinese Medicine

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.

Locations

Country	Name	City	State
China	Shanghai Municipal Hospital of Traditional Chinese Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Feng Tao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percent Change in Body Weight	Measuring body weight at the required time point	2021-2027
Primary	Percentage of Participants who Achieve =5% Body Weight Reduction	Measuring body weight at the required time point	2021-2027
Secondary	Percentage of participants who achieve =10% body weight reduction	Measuring body weight at the required time point	2021-2027
Secondary	Percentage of participants who achieve =15% body weight reduction	Measuring body weight at the required time point	2021-2027
Secondary	Change in waist circumference	Measuring waist circumference at the required time point	2021-2027
Secondary	Change in glycosylated hemoglobin A-1c(Hba1c)	Measuring Hba1c at the required time point	2021-2027
Secondary	Change in fasting blood glucose	Measuring fasting blood glucose at the required time point	2021-2027
Secondary	Change in Three-Factor eating questionnaire(TFEQ-R21)	Investigating TFEQ-R21 at the required time point	2021-2027
Secondary	Change in food craving questionnaire-trait(FCQ-T)	Investigating FCQ-T at the required time point	2021-2027
Secondary	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
Secondary	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
Secondary	Change in cholecystokinin(CCK)	Measuring CCK in serum at the required time point	2021-2027
Secondary	Change in bile acid	Measuring bile acid in serum and feces at the required time point	2021-2027
Secondary	Change in peptide YY(PYY)	Measuring PYY in serum at the required time point	2021-2027
Secondary	Change in ghrelin(GHRL)	Measuring GHRL in serum at the required time point	2021-2027