Traditional Chinese Medicine TreatmentNCT06419764
Combining Chinese Medicine and Nutrition to Enhance Weight Loss After Bariatric Surgery
A study testing Spleen Invigorating and Weight Reducing Decoction and Diet and meal replacements in people with Traditional Chinese Medicine Treatment and Weight Change, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
This study aims to investigate the effects of Chinese herbal granule preparations on improving gastrointestinal symptoms in patients after bariatric surgery. It seeks to establish a novel treatment model that combines bariatric surgery with traditional Chinese medicine, providing clinical practice with additional… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traditional Chinese Medicine Treatment, Weight Change
- What is being tested?
- Spleen Invigorating and Weight Reducing Decoction and Diet and meal replacements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI ≥ 27.5 kg/m²;
- Undergoing metabolic bariatric surgery;
- Traditional Chinese Medicine syndrome differentiation classified as Spleen Deficiency and Excess Dampness syndrome.
Who cannot join
- Contraindications for metabolic bariatric surgery;
- Type 1 diabetes;
- Complicated by other significant systemic diseases, such as severe liver and kidney diseases, malignant tumors, psychiatric disorders, etc;
- Concurrent use of other medications or treatments that may affect body weight, such as metformin, semaglutide, endoscopic interventions, etc;
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate the effects of Chinese herbal granule preparations on improving gastrointestinal symptoms in patients after bariatric surgery. It seeks to establish a novel treatment model that combines bariatric surgery with traditional Chinese medicine, providing clinical practice with additional evidence-based medical support.
- Being tested
- Spleen Invigorating and Weight Reducing Decoction, Diet and meal replacements
- Medical subject headings
- Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spleen Invigorating and Weight Reducing DecoctionDrug
Composition: Raw Astragalus (Huang Qi) 5g, Cang Zhu 5g, Fructus Aurantii Immaturus (Zhi Shi) 3g, Prepared Rhubarb (Shu Jun) 3g, Red Peony Root (Chi Shao Yao) 3g, Crataegus (Shan Zha) 3g, Tribulus (Bai Jie Li) 2g, Cimicifuga (Sheng Ma) 1g.
Granule form, for oral administration. Take 1 dose daily (2 bags, once in the morning and once in the evening, dissolved in water), for a course of 1 month.
Diet and meal replacementsOther
The dietitian provides recommended meal plans based on body weight, and meal replacements are used postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| nutrition intervention group | Active comparator | Postoperative patients are routinely provided with meal replacement recommendations and dietary plans. Receives: Other: Diet and meal replacements |
| Traditional Chinese Medicine combined with nutritional intervention | Experimental | Chinese herbal treatment is given on the basis of routine dietary intervention. Receives: Drug: Spleen Invigorating and Weight Reducing Decoction; Other: Diet and meal replacements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in body weight
Measured: Before bariatric surgery, 1 month after surgery, and 3 months after surgery.
Secondary outcomes (3)
Traditional Chinese Medicine syndrome score
Measured: Before bariatric surgery, 1 month after surgery, and 3 months after surgery.
blood glucose indicators
HbA1c, blood glucose, insulin levels
Measured: Before bariatric surgery, 1 month after surgery, and 3 months after surgery.
blood lipid profile
total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol
Measured: Before bariatric surgery, 1 month after surgery, and 3 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start1 Feb 2024
- Primary completionJul 2024 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traditional Chinese Medicine TreatmentStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hua Meng, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419764
- Sponsor's protocol ID
- CCMNEWLABS
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 17 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Chinese Medicine and Nutrition to Enhance Weight Loss After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06419764
- Acronym / sponsor ID
- CCMNEWLABS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the effects of Chinese herbal granule preparations on improving gastrointestinal symptoms in patients after bariatric surgery. It seeks to establish a novel treatment model that combines bariatric surgery with traditional Chinese medicine, providing clinical practice with additional evidence-based medical support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nutrition intervention group | Active comparator | Other: Diet and meal replacementsPostoperative patients are routinely provided with meal replacement recommendations and dietary plans. |
| Traditional Chinese Medicine combined with nutritional intervention | Experimental | Drug: Spleen Invigorating and Weight Reducing Decoction, Other: Diet and meal replacementsChinese herbal treatment is given on the basis of routine dietary intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI ≥ 27.5 kg/m²;
- Undergoing metabolic bariatric surgery;
- Traditional Chinese Medicine syndrome differentiation classified as Spleen Deficiency and Excess Dampness syndrome.
Key exclusion criteria (5 listed)
- Contraindications for metabolic bariatric surgery;
- Type 1 diabetes;
- Complicated by other significant systemic diseases, such as severe liver and kidney diseases, malignant tumors, psychiatric disorders, etc;
- Concurrent use of other medications or treatments that may affect body weight, such as metformin, semaglutide, endoscopic interventions, etc;
- Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spleen Invigorating and Weight Reducing DecoctionComposition: Raw Astragalus (Huang Qi) 5g, Cang Zhu 5g, Fructus Aurantii Immaturus (Zhi Shi) 3g, Prepared Rhubarb (Shu Jun) 3g, Red Peony Root (Chi Shao Yao) 3g, Crataegus (Shan Zha) 3g, Tribulus (Bai Jie Li) 2g, Cimicifuga (Sheng Ma) 1g. Granule form, for oral administration. Take 1 dose daily (2 bags, once in the morning and once in the evening, dissolved in water), for a course of 1 month. | Drug | Traditional Chinese Medicine combined with nutritional intervention |
| Diet and meal replacementsThe dietitian provides recommended meal plans based on body weight, and meal replacements are used postoperatively. | Other | Traditional Chinese Medicine combined with nutritional intervention, nutrition intervention group |
Primary outcome
Percentage change in body weight
Time frame: Before bariatric surgery, 1 month after surgery, and 3 months after surgery.
3 secondary outcomes
Traditional Chinese Medicine syndrome score
Time frame: Before bariatric surgery, 1 month after surgery, and 3 months after surgery.
blood glucose indicators
Time frame: Before bariatric surgery, 1 month after surgery, and 3 months after surgery.
blood lipid profile
Time frame: Before bariatric surgery, 1 month after surgery, and 3 months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spleen Invigorating and Weight Reducing Decoction and Diet and meal replacements in people with Traditional Chinese Medicine Treatment and Weight Change, run by China-Japan Friendship Hospital 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huang Yishan, doctor (18810621201, bucmyishan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in body weight (time frame: Before bariatric surgery, 1 month after surgery, and 3 months after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.