Internal Hemorrhoids or Mixed Hemorrhoids with Bleeding
Conditions
Interventions
Investigational Group:Luohuazizhu Granules(One sachet per dose),Yiqing Capsule Placebo matching (two capsules per dose)
Control:Luohuazizhu Granules Placebo matching(One sachet per dose),Yiqing Capsule(two capsules per dose)
Sponsors
Xiyuan Hospital China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Subjects aged 18–70 years (inclusive) male or female. 2.Confirmed diagnosis of internal hemorrhoids (Grade I/II) or mixed hemorrhoids via proctoscopy. 3.Baseline hematochezia score =1 (per [Specify Scale e.g. Sodergren Scale]). 4.Full cognitive capacity willingness to comply with study procedures and documented informed consent.
Exclusion criteria
Exclusion criteria: 1.Patients with simple external hemorrhoids internal hemorrhoids or mixed hemorrhoids (internal component graded III-IV) or thrombosed/inflamed external component of mixed hemorrhoids. 2.Patients with concurrent anorectal disorders (e.g. anal fissure anal fistula perianal abscess condyloma acuminatum) congenital anorectal malformations suspected anorectal neoplasia (palpable mass on digital rectal examination) or inflammatory bowel disease (Crohn's disease ulcerative colitis). 3.History of severe gastrointestinal diseases:Peptic ulcer gastrointestinal hemorrhage digestive system malignancies pyloric stenosis gastric shunt surgery. 4.Allergic constitution (hypersensitivity to =2 medications) and/or known allergy to any ingredient of the investigational product. 5.Pregnant/lactating women; or participants of childbearing potential (including males with fertile female partners) planning pregnancy or unwilling to use effective contraception from screening until 1 month post-treatment. 6.Severe cardiovascular/cerebrovascular diseases; hepatic dysfunction (ALT or AST =1.5×ULN); renal impairment (serum creatinine >ULN); coagulopathies; moderate-to-severe anemia (hemoglobin <90 g/L); or hematologic disorders (e.g. leukemia lymphoma) affecting coagulation. 7.Alcohol abuse and/or substance dependence (psychoactive drugs narcotics). 8.Current use of antiplatelet/anticoagulant agents or application of any hemorrhoid treatments (e.g. suppositories venotonics hemostatics) within 1 week prior. 9.Participation in other clinical trials within 3 months before enrollment. 10.Other conditions deemed ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Response Rate After 7 Days of Medication; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Resolution of Bleeding (Rectal Bleeding);Change in Number of Bleeding Points and Erosion Area from Baseline Assessed by Anoscopy at Day 7;Time to disappearance of anal pain;Change from baseline in hemorrhoidal swelling score after 7 days of medication/treatment;Change in anal discomfort score from baseline after 7 days of medication/treatment;Count of rescue medication administrations;Change from baseline in hemorrhoidal prolapse score after 7 days of medication;Change in Bleeding Score from Baseline after 7 Days of Medication;Change from Baseline in Number of Bleeding Points and Erosion Area under Anoscopy after 7 Days of Medication;Time to disappearance of anal discomfort;Change from Baseline in Hemorrhoid Mucosal Status Score under Proctoscopy after 7 Days of Medication; | — |
Countries
China
Contacts
Public ContactJIa xiaoqiang
Xiyuan Hospital China Academy of Chinese Medical Sciences
Outcome results
None listed