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ObesityNCT05122936

Observation on Obesity Undergoing XOWI

An observational study of Obesity and Traditional Chinese Medicine, run by Feng Tao at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Obesity, Traditional Chinese Medicine
What is being tested?
XRXPY-based Obesity Wellness Intervention(SOWI)
Type of treatment
Pill or oral medicine
How many people
500 participants
Where
1 siteChina
Study dates
30 Nov 2021to 14 Nov 2027
How long will I take part?
2 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 500 Patients from the outpatient clinic of Shanghai Municipal Hospital of TCM will be enrolled in this study.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Shanghai Municipal Hospital of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality, 200071

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
XRXPY-based Obesity Wellness Intervention(SOWI)
Keywords
Obesity, Traditional Chinese medicine, SRXPY-based Obesity Wellness Intervention
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05122936
Study groupRoleWhat they receive
XOWI GroupObesity Cohort undergoing XRXPY-based Obesity Wellness Intervention
Receives: Combination Product: XRXPY-based Obesity Wellness Intervention(SOWI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Percent Change in Body Weight

    Measuring body weight at the required time point

    Measured: 2021-2027

  2. Percentage of Participants who Achieve ≥5% Body Weight Reduction

    Measuring body weight at the required time point

    Measured: 2021-2027

Secondary outcomes (13)

  1. Percentage of participants who achieve ≥10% body weight reduction

    Measuring body weight at the required time point

    Measured: 2021-2027

  2. Percentage of participants who achieve ≥15% body weight reduction

    Measuring body weight at the required time point

    Measured: 2021-2027

  3. Change in waist circumference

    Measuring waist circumference at the required time point

    Measured: 2021-2027

  4. Change in glycosylated hemoglobin A-1c(Hba1c)

    Measuring Hba1c at the required time point

    Measured: 2021-2027

  5. Change in fasting blood glucose

    Measuring fasting blood glucose at the required time point

    Measured: 2021-2027

  6. Change in Three-Factor eating questionnaire(TFEQ-R21)

    Investigating TFEQ-R21 at the required time point

    Measured: 2021-2027

  7. Change in food craving questionnaire-trait(FCQ-T)

    Investigating FCQ-T at the required time point

    Measured: 2021-2027

  8. 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).

    Measured: 2021-2027

  9. 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).

    Measured: 2021-2027

  10. Change in cholecystokinin(CCK)

    Measuring CCK in serum at the required time point

    Measured: 2021-2027

  11. Change in bile acid

    Measuring bile acid in serum and feces at the required time point

    Measured: 2021-2027

  12. Change in peptide YY(PYY)

    Measuring PYY in serum at the required time point

    Measured: 2021-2027

  13. Change in ghrelin(GHRL)

    Measuring GHRL in serum at the required time point

    Measured: 2021-2027

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2021
  2. Study start30 Nov 2021
  3. Primary completion14 Nov 2026 (estimated)
  4. Study completion14 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05122936
Sponsor's protocol ID
SHMHTCM
Status last verified
Mar 2024
First submitted
24 Oct 2021
Last updated
22 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data materials will publish articles

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Traditional Chinese Medicine, run by Feng Tao at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Percent Change in Body Weight (time frame: 2021-2027). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05122936.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.

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