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A multicenter, randomized, parallel controlled clinical study of Chuanbei Qing - Magnesium sulfate sodium sulfate and potassium sulfate concentrate oral solution for intestinal preparation before colonoscopy in adult patients

A multicenter, randomized, parallel controlled clinical study of Chuanbei Qing - Magnesium sulfate sodium sulfate and potassium sulfate concentrate oral solution for intestinal preparation before colonoscopy in adult patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076575
Enrollment
Unknown
Registered
2023-10-12
Start date
2023-10-15
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy

Interventions

Experimental group (Chuan Bei Qing group):Diet preparation 3 days before examination. Intestinal cleaning usually requires two bottles of Chuanbaiqing, which are taken twice in the evening of the day
Control group (Fujingqing group):Diet preparation 3 days before examination. Generally, 4 bags of Fujingqing were taken twice after dinner on the day before the examination and 4 hours before the exam

Sponsors

Peking Union Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-70 years old, gender unlimited; 2. Subjects preparing for colonoscopy; 3. Persons with autonomous capacity; 4. Liver, kidney and heart function are normal within 3 months (urine routine, blood biochemistry, electrocardiogram, etc., are normal); 5. Those who agree to participate in this experiment and sign the informed consent: 6. Those who can participate in all tests until the completion of the test

Exclusion criteria

Exclusion criteria: 1. Gastrointestinal perforation, toxic colitis, toxic megacolon, severe intestinal obstruction or gastrointestinal stenosis, obstruction of gastric empting (e.g., gastric weakness, gastric retention), any of the previous gastrointestinal surgery history; 2. People who are allergic to the ingredients contained in the experimental drug and the control drug; 3. Laboratory results at baseline showed clinical electrolyte abnormalities (hypernatremia (serum Na > 145mmol/L), hyponatremia (serum Na 1.45mmol/L), hypokalemia (serum K 110bpm* Note: Two additional readings should be taken at least 5 minutes apart to confirm sinus tachycardia at 110bpm. ? sinus bradycardia 100 bpm)... ? interface escape waveform. Supraventricular tachycardia (>100 bpm). ? ventricular tachycardia (persistent, pleomorphic, or monomorphic). ? Atrial fibrillation with rapid ventricular response (heart rate >110bpm). ? Evidence of diploid, triploid, or multifocal ventricular premature beats. ? chamber puff ? ventricular fibrillation ? tip torsion ventricular tachycardia ?R-on-T phenomenon ? Wide QRS tachycardia (diagnosis unknown) ? electric alternations. ? ventricular autonomous rhythm - heart rate <100bpm ? MOBITZtype II second - or third-degree atrioventricular (AV) block ? atrioventricular separation ? double branch block ? three-branch block ? left bundle branch block 9. Patients with severe cardiac insufficiency (NYHA Grade III-IV); 10. Severe liver insufficiency (ALT, AST, TBil any item higher than 2 times the upper limit of normal); 11. Participants who were tested with drugs affecting gastrointestinal motility, such as motility promoting drugs (metoclopramide, domperidone, Itopride, Moxapride, cinibili, etc.), erythromycin antibiotics, purgative agents (phenolphthalein, senna, bisaxidine, Ma Ren Runchang pills, Buzhong Yiqi Decoction, Siwu decoction, etc., including diet tea) 3 days before admission; 12. Researchers believe it may interfere with participants participating in the study or assessment.

Design outcomes

Primary

MeasureTime frame
Intestinal cleanliness;

Secondary

MeasureTime frame
Intestinal bubble evaluation;Intestinal polyp detection rate;Researcher satisfaction;Subject compliance;

Countries

China

Contacts

Public ContactYang Aiming

Peking Union Hospital, Chinese Academy of Medical Sciences

yangaiming@medmail.com.cn+86 139 1187 6975

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026