Functional abdominal pain in children
Conditions
Interventions
Experimental group:Xiaoer Foshao and Zhong granules
Control group:Low dose of Foshao and middle granule in children
Sponsors
Xiyuan Hospital China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
4 Years to 13 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria of Western medicine PF-NOS; (2) Conforming to the TCM standard of Qi-block syndrome differentiation; (3) Within 1 month before treatment the maximum FS-R score of abdominal pain was =4 points and the attack was =1 time per week; (4) The maximum FS-R score for abdominal pain during screening/induction period was =4 points; (5) Age 4 ~ 13 years old (including both ends) can cooperate to complete the relevant description and record; (6) The guardian of the child gives informed consent and or signs the informed consent with the child (=8 years old).
Exclusion criteria
Exclusion criteria: (1) Patients with intraperitoneal organic diseases such as gastrointestinal infection (acute appendicitis colitis etc.) gastrointestinal obstruction chronic intussusception etc.; (2) Patients with a history of abdominal or gastrointestinal surgery; (3) spasmolytic drugs antidepressants antihistamines gastromotogenic drugs probiotics acid suppressive preparations Chinese medicine for the treatment of the disease Chinese medicine external therapy etc. were used within 1 week before screening; (4) Symptomatic abdominal pain that is abdominal pain caused by extra-intestinal diseases such as upper respiratory tract infection suppurative tonsillitis liver and bile diseases urinary diseases intestinal parasitic diseases etc.; (5) Patients with definite diagnosis of functional dyspepsia (FD) irritable bowel syndrome (IBS) and abdominal migraine (AM); (6) Alarming symptoms such as fever bleeding anemia acid reflux persistent vomiting nocturnal diarrhea unintentional weight loss or abdominal mass found on physical examination that cannot be explained by functional gastrointestinal disease; (7) Cr exceeding the upper limit of normal value or any item of ALT and AST exceeding 1.5 times the upper limit of normal value; (8) Patients with severe malnutrition rickets and serious primary diseases of the heart brain liver kidney and hematopoietic system; (9) those with a definite diagnosis of mental disorders (such as anxiety depression somatization and mood symptoms); (10) Allergic to known components of the test drug; (11) Participants who had participated in other clinical trials within 30 days prior to screening; (12) Participants considered inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the maximum FPS-R score for abdominal pain from baseline at week 2 of administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change of the number of days with abdominal pain from baseline at week 1 and week 2;Changes of TCM syndrome score from baseline after 1 and 2 weeks of medication;renal function;Change in the maximum FPS-R score for abdominal pain from baseline at week 1;The change values of the maximum FS-R score, the number of abdominal pain attacks, the number of abdominal pain attacks and the longest duration of abdominal pain from baseline during the drug follow-up period;Then routine +OB;urinalysis;Abdominal b-ultrasonography;Change in the longest duration of abdominal pain from baseline at week 1 and week 2;Blood routine examination;Liver function;The disappearance rate of symptoms after 1 week and 2 weeks;12-lead electrocardiogram;Change in frequency of abdominal pain attacks from baseline at week 1 and week 2; | — |
Countries
China
Contacts
Public ContactJixiaohua
Xiyuan Hospital China Academy of Chinese Medical Sciences
Outcome results
None listed