18 Haz APPENDIX B: CASE REPORT FORMS (CRFs) TEMPLATE
Study Protocol Number: NA-2024-01
Participant ID:
Site ID:
CRF Section 1: Screening & Baseline Demographics (Day 0)
Participant ID: ___________
Date of Birth: __/__/____ (DD/MM/YYYY)
Age (Years): ____
Gender: [ ] Male [ ] Female
Ethnicity: [ ] Caucasian [ ] Asian [ ] African [ ] Other: ______
Medical History (Relevant):
IBD: [ ] Yes [ ] No
Diabetes: [ ] Yes [ ] No
Obesity (BMI): [ ] Yes [ ] No (BMI: ____ kg/m²)
Pregnancy/Lactation: [ ] Yes [ ] No
Other Relevant Conditions: ________________________
Hemorrhoid Symptom Duration: ____ weeks / months / years
Anoscopic Examination (Investigator Assessment):
Hemorrhoid Grade (Goligher): [ ] Grade 1 [ ] Grade 2 [ ] Grade 3 [ ] Grade 4
Presence of other anorectal conditions (Abscess, Warts, Furuncles, Fissure, etc.):
[ ] None
[ ] Abscess
[ ] Warts
[ ] Furuncles
[ ] Anal Fissure
[ ] Other: ________________________
Inclusion/Exclusion Met? [ ] Yes [ ] No
Informed Consent Obtained? [ ] Yes [ ] No
Date of Randomization: __/__/____ (DD/MM/YYYY)
Allocated Group: [ ] Nimsai Herbal [ ] Placebo (Investigator blinded)
CRF Section 2: Daily Symptom Log (Participant Reported – Day 1 to Day 10)
Participant ID: ___________ Study Day: ____
| Symptom | VAS Score (0-10) – *0=None, 10=Worst imaginable* |
|—|—|
| Pain | ____ |
| Bleeding | ____ |
| Itching | ____ |
| Medication Adherence: (Number of capsules taken today) | ____ |
| Any New/Worsening Symptoms or Adverse Events? (Describe briefly) | ____________________________________________________________________ |
(This section would be repeated for each day of the 10-day intervention period.)
CRF Section 3: Final Assessment & Adverse Events (Day 10)
Participant ID: ___________ Study Day: 10
Date of Final Assessment: __/__/____ (DD/MM/YYYY)
Anoscopic Examination (Investigator Assessment):
Hemorrhoid Grade (Goligher) at Day 10: [ ] Grade 1 [ ] Grade 2 [ ] Grade 3 [ ] Grade 4
Hemorrhoid Regression (Reduction of ≥1 Goligher Grade): [ ] Yes [ ] No
Symptom Resolution (Investigator Assessment based on Participant Logs):
Complete Symptom Resolution (VAS=0 for Pain, Bleeding, Itching): [ ] Yes [ ] No
VAS Scores (Investigator Verified):
Pain (Day 10): ____
Bleeding (Day 10): ____
Itching (Day 10): ____
Adherence Assessment (Capsule Count):
Number of capsules prescribed: ____
Number of capsules returned: ____
Calculated Adherence (%): ____%
Adverse Events (AEs) Overview (Throughout 10-day period):
Total Number of AEs reported: ____
Serious AEs (SAEs): [ ] Yes [ ] No (If Yes, attach SAE form)
Most Frequent AEs (e.g., mild GI discomfort):
GI discomfort: [ ] Yes [ ] No (Severity: [ ] Mild [ ] Moderate [ ] Severe)
Other AE 1: ________________ (Severity: [ ] Mild [ ] Moderate [ ] Severe)
Other AE 2: ________________ (Severity: [ ] Mild [ ] Moderate [ ] Severe)
Relationship to Study Drug: [ ] Related [ ] Unrelated [ ] Unlikely
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