The impact of moxibustion on digestive system function and gut bacteria pattern in chronic kidney disease patients undergoing peritoneal dialysis
| ISRCTN | ISRCTN14267067 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14267067 |
| Secondary identifying numbers | 20240407 |
- Submission date
- 07/04/2024
- Registration date
- 10/04/2024
- Last edited
- 09/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Through extensive clinical experience, it has been demonstrated that blending traditional Chinese medicine with Western medical practices offers distinct benefits for treating chronic renal failure. This combination allows for mutual enhancement, yielding favorable outcomes such as alleviation of clinical symptoms, enhancement of renal function, and deceleration of renal failure progression. Our study aims to assess the effectiveness of incorporating moxibustion alongside peritoneal dialysis (PD) in treating patients diagnosed with chronic renal failure (CRF).
Who can participate?
Patients aged 18 years or older with chronic renal failure receiving moxibustion combined with peritoneal dialysis
What does the study involve?
We studied patients diagnosed with chronic kidney failure (CRF) who underwent moxibustion in conjunction with peritoneal dialysis (PD) at our hospital (referred to as the moxibustion group), alongside patients also diagnosed with CRF who solely underwent PD (referred to as the control group).
What are the possible benefits and risks of participating?
Benefits:
1. Gain access to novel treatment options.
2. Alleviate financial strain.
3. Enhance understanding of the latest developments regarding your condition.
4. Receive increased attention from medical professionals.
5. Access high-quality medical care.
Risks:
1. Requires additional energy expenditure.
2. Possibility of ineffective treatment.
Where is the study run from?
Jinshan Branch of the Sixth People's Hospital (China)
When is the study starting and how long is it expected to run for?
March 2020 to March 2023
Who is funding the study?
Jinshan Branch of the Sixth People's Hospital (China)
Who is the main contact?
LiuKun, saynever2004@126.com
Contact information
Public, Scientific, Principal Investigator
Jinshan Branch of the Sixth People's Hospital, No.147 Health Road, Zhujing Town, Jinshan District
Shanghai
201599
China
 ORCID ID |
0000-0003-3531-335X |
|---|---|
| Phone | +86 136 1179 5408 |
| saynever2004@126.com |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Study on clinical effect and mechanism of moxibustion therapy in improving gastrointestinal dysfunction in uremia peritoneal dialysis |
| Study objectives | Moxibustion combined with peritoneal dialysis (PD) can regulate the structure of the gut microbiota to improve renal and gastrointestinal functions in chronic renal failure (CRF) patients. |
| Ethics approval(s) |
Approved 30/12/2020, Shanghai Sixth People's Hospital Jinshan Branch Medical Ethics Management Committee (Jinshan Branch of the Sixth People's Hospital, No.147 Health Road, Zhujing Town, Jinshan District, Shanghai, 201599, China; +86 21 5731 0206; lunli2020@126.com), ref: jszxyy202007 |
| Health condition(s) or problem(s) studied | Chronic kidney disease peritoneal dialysis patients |
| Intervention | From March 2020 to February 2022, 52 patients with chronic kidney failure (CRF) who received moxibustion combined with peritoneal dialysis (PD) in our hospital (moxibustion group) and 50 patients with CRF who only received PD (control group) will be studied to observe the effects of moxibustion on gastrointestinal function and intestinal microbial structure in peritoneal dialysis patients with chronic kidney disease Moxibustion group: Moxibustion treatment was performed during PD, along with conventional Western medicine treatments, such as improving anemia and controlling blood sugar. Control group: only PD and western medicine conventional treatment. Both groups were given appropriate diet and gastrointestinal management, and the entire study period lasted 12 weeks. |
| Intervention type | Mixed |
| Primary outcome measure | 1. After 12 weeks of treatment, gastrointestinal function was analyzed by blood tests of secretion of gastrin, motilin, cholecystokinin, somatostatin and growth hormone releasing peptide before and after treatment. 2. Fecal samples were collected 12 weeks after treatment for 16S rDNA analysis to observe changes in fecal microbial characteristics |
| Secondary outcome measures | Renal function index: After 12 weeks of treatment, Blood routine markers and blood electrolytes were detected by blood. Routine biochemical parameters and 24-hour urinary protein quantification (UPQ) by urine testing |
| Overall study start date | 01/03/2020 |
| Completion date | 01/03/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 71 Years |
| Sex | Both |
| Target number of participants | 102 |
| Total final enrolment | 102 |
| Key inclusion criteria | 1. Aged > 18 years old; 2. Clinical diagnosis of CRF with specific indications for PD. |
| Key exclusion criteria | 1. Decreased peritoneal clearance rate caused by various abdominal lesions; 2. Within 3 days of abdominal surgery and no complete healing of the wound, which could easily lead to dialysate leaks; 3. Localized inflammatory lesions in the peritoneum, which could be spread by PD; 4. Late pregnancy or large intra-abdominal tumors, which could result in reduced abdominal volume and subsequent unsatisfactory effect of PD; 5. Extensive abdominal wall infection or severe burns, which could cause failure of intubation; 6. Intra-abdominal vascular diseases, such as polyangiitis, severe arteriosclerosis, scleroderma, which could reduce the dialysis efficacy; 7. Severe respiratory insufficiency; in such patients, excessive fluid intake would aggravate respiratory insufficiency, and if the patients were still required to receive PD, fluid intake was less; 8. Long-term insufficiency of protein and caloric intake; such patients were not suitable for PD because PD could lead to daily loss of protein more than 6 g |
| Date of first enrolment | 01/03/2020 |
| Date of final enrolment | 28/02/2022 |
Locations
Countries of recruitment
- China
Study participating centre
Shanghai
201599
China
Sponsor information
Hospital/treatment centre
Jinshan Branch of the Sixth People's Hospital, No.147 Health Road, Zhujing Town, Jinshan District
Shanghai
201599
China
| Phone | +86 21 5731 0206 |
|---|---|
| lunli2020@126.com |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impace peer-reviewed journal |
| IPD sharing plan | Please use contact details to request raw data (LiuKun,saynever2004@126.com) |
Editorial Notes
08/04/2024: Trial's existence confirmed by Shanghai Sixth People's Hospital Jinshan Branch Medical Ethics Management Committee
