Double-Blind, Placebo-Controlled, Parallel-Group Randomized Controlled Trial to Evaluate the Efficacy and Safety of Nimsai Herbal in Patients With Grade 2-3 Hemorrhoids
Phase: NA
Conditions: Hemorrhoids, Hemorrhoidal Disease
Sponsor: Nimsai Academia

 
 
 
 
 
 
APPENDIX B: CASE REPORT FORMS (CRFs) TEMPLATE 
 
Protocol Title: Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Trial to Evaluate 
the Efficacy and Safety of Nimsai Herbal Capsules in Participants with Grade 2-3 Internal 
Hemorrhoids 
NCT Number: NCT07034820 
Protocol Number: NA-2024-001  
Document Date: October 14, 2021  
Version: 1.2 
Sponsor: Nimsai Academia Bursa, Türkiye 
Principal Investigator: Cem Atabiner Nimsai Academia 
Center Phone: +90 532 459 3292 
Email: cem.atabiner@kecioutdoor.com.tr 
Prepared by: Nimsai Academia Bursa, Türkiye 
Submission Format: PDF/A 
 
Confidentiality Statement: This document contains confidential information and is intended 
solely for authorized personnel, investigators, and regulatory authorities. Unauthorized 
reproduction or distribution is prohibited. No participant names or identifiable information are 
included. 
 
 
 

 
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.): 
o 
[ ] None 
o 
[ ] Abscess 
o 
[ ] Warts 
o 
[ ] Furuncles 
o 
[ ] Anal Fissure 
o 
[ ] 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 g1 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): 
o 
GI discomfort: [ ] Yes [ ] No (Severity: [ ] Mild [ ] Moderate [ ] Severe) 
o 
Other AE 1: ________________ (Severity: [ ] Mild [ ] Moderate [ ] Severe) 
o 
Other AE 2: ________________ (Severity: [ ] Mild [ ] Moderate [ ] Severe) 
÷ 
Relationship to Study Drug: [ ] Related [ ] Unrelated [ ] Unlikely