Clinical study of Zisheng Wan Recipe in the treatment of targeted drug-related diarrhea
- Conditions
- Targeted Drug-Associated Diarrhea
- Registration Number
- ITMCTR2200005967
- Lead Sponsor
- Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) Those diagnosed with non-small cell lung cancer by histopathology;
(2) Currently receiving targeted drug therapy and meeting the diagnostic criteria for mild or moderate diarrhea;
(3) In line with the results of TCM syndrome differentiation of spleen and stomach weakness
(4) Karnofsky score = 70 points, ZPS score = 2 points;
(5) The age is 18-80 years old (inclusive), and the gender is not limited;
(6) Estimated survival time > 3 months;
(7) No intellectual or mental disorder, normal language expression ability, ability to judge their own general condition, and cooperative evaluation of diarrhea and quality of life;
(8) Those who understand and agree to participate in this study and sign the informed consent form.
Another 10 patients with non-targeted therapy for non-small cell lung cancer recruited were required to have no targeted therapy and were more than 2 weeks away from the oncology western medicine system treatment, such as chemotherapy, targeted therapy, radiotherapy, and immunotherapy.
1. Those who do not meet the inclusion criteria;
2. Those with functional impairment of important organs;
3. Caused by other causes (such as irritable bowel syndrome, allergic enteritis, infectious diarrhea, infectious diarrhea, ulcerative colitis, malabsorption, parasitic infection, poisoning, bacillary dysentery, cholera, typhoid and paratyphoid fever) , diarrhea caused by radiation enteritis, hyperthyroidism, hypothyroidism, food and drug allergies, radiation enteritis, metabolic diseases, etc.); patients with persistent or chronic diarrhea before using targeted drugs;
4. Allergic constitution, allergic to montmorillonite powder and traditional Chinese medicine;
5. Those who cannot take the drugs involved in this clinical study;
6. Those who have participated in clinical trials of other drugs within the past 3 months;
7. Drugs that may affect gastrointestinal function and thus affect the judgment of efficacy have been used within one week (such as H-receptor antagonists, proton pump inhibitors, macrolide antibiotics, misoprostol, acarbose, lactose Fructose oral solution, biguanides, etc.);
8. Those with other progressive serious diseases (such as diabetes, hypertension, hyperthyroidism with serious complications);
9. Patients with serious complications (such as hypovolemic shock, gastrointestinal perforation, severe bleeding, nephrotic syndrome, etc.);
10. Women who are pregnant or breastfeeding, or women who have the desire to become pregnant in the near future;
11. Those with severe mental disorders or communication disorders;
12. Those who cannot follow up on schedule or those with poor compliance.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method D-lactate;diamine oxidase;Gut flora;endotoxin;
- Secondary Outcome Measures
Name Time Method