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

 
Citation: Hopewell S, Chan AW, Collins GS, Hróbjartsson A, Moher D, Schulz KF, et al. CONSORT 2025 
Statement: updated guideline for reporting randomised trials. BMJ. 2025; 388:e081123. 
https://dx.doi.org/10.1136/bmj-2024-081123  
© 2025 Hopewell et al. This is an Open Access article distributed under the terms of the Creative Commons 
Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, 
distribution, and reproduction in any medium, provided the original work is properly cited. 
 
 
 
 
 
 
 
Study Flow Diagram 
 
Official Title: 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 
 
NCT Number: NCT07034820 
Protocol Number: NA-2024-001 
Document Date: November 15, 2021 
Sponsor: Nimsai Academia Bursa, Türkiye 
Principal Investigator: Cem Atabiner Nimsai Academia  
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. 
 
 
 

 
Citation: Hopewell S, Chan AW, Collins GS, Hróbjartsson A, Moher D, Schulz KF, et al. CONSORT 2025 
Statement: updated guideline for reporting randomised trials. BMJ. 2025; 388:e081123. 
https://dx.doi.org/10.1136/bmj-2024-081123  
© 2025 Hopewell et al. This is an Open Access article distributed under the terms of the Creative Commons 
Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, 
distribution, and reproduction in any medium, provided the original work is properly cited. 
 
CONSORT 2025 Flow Diagram 
Flow diagram of the progress through the phases of a randomised trial of two groups  
(that is, enrolment, intervention allocation, follow-up, and data analysis)  
Assessed for eligibility  
(n= 300) 
Excluded (n=0) 
Not meeting inclusion criteria (n=0) 
Declined to participate (n=0) 
Other reasons (n=0) 
Allocated to intervention (n= 150) 
Received allocated intervention (n= 150) 
Did not receive allocated intervention  
(give reasons) (n= 0) 
Randomised (n= 300 ) 
Analysed for primary outcome (n= 150) 
(Nimsai Herbal) 
Excluded from analysis (give reasons) (n=0) 
Nimsai Herbal 
GroupDiscontinued intervention  
(give reasons) (n=0) 
Lost to follow-up for primary outcome  
(give reasons) (n=0): 
Placebo Group 
Discontinued intervention  
(give reasons) (n=0) 
Lost to follow-up for primary outcome  
(give reasons) (n=0): 
Allocated to intervention (n= 150) 
Received allocated intervention (n= 150) 
Did not receive allocated intervention  
(give reasons) (n=0) 
Analysed for primary outcome (n= 150) 
(Placebo) 
Excluded from analysis (give reasons) (n=0) 
Analysis 
Enrolment 
Allocation 
Follow-Up