Trial Outcomes & Findings for War-Drill Model Guided Treatment of Hemorrhoids With Nimsai Herbal (NAJ) (NCT NCT07034820)
NCT ID: NCT07034820
Last Updated: 2025-07-31
Results Overview
Hemorrhoid regression was defined as a reduction of at least one Goligher grade or a ≥75% reduction in composite hemorrhoid severity score by Day 10. (The Goligher Classification of Hemorrhoids is a 4-point scale (Grade I to IV) used for hemorrhoid severity, where higher scores indicate worse disease.)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
300 participants
Primary outcome timeframe
Day 10 (end of treatment period)
Results posted on
2025-07-31
Participant Flow
Participant milestones
| Measure |
Nimsai Herbal Group
Participants in this arm received oral Nimsai Herbal (600 mg, one capsule per day) for 10 consecutive days.
Nimsai Herbal: Oral Nimsai Herbal is a novel botanical formulation, administered as one 600 mg capsule per day for a duration of 10 consecutive days. It is specifically designed to target the underlying venous congestion hypothesized by the War-Drill Model, aiming to promote hemorrhoid regression and symptom resolution.
|
Placebo Group
Participants in this arm received oral placebo (identical in appearance, taste, and packaging to Nimsai Herbal) for 10 consecutive days.
Nimsai Herbal: This intervention consisted of an oral placebo, formulated to be identical in appearance, taste, and packaging to Nimsai Herbal. It was administered as one capsule per day for 10 consecutive days to ensure blinding and serve as a control for comparison.
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
150
|
|
Overall Study
COMPLETED
|
150
|
150
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Nimsai Herbal Group
n=150 Participants
Participants in this arm received oral Nimsai Herbal (600 mg, one capsule per day) for 10 consecutive days.
Nimsai Herbal: Oral Nimsai Herbal is a novel botanical formulation, administered as one 600 mg capsule per day for a duration of 10 consecutive days. It is specifically designed to target the underlying venous congestion hypothesized by the War-Drill Model, aiming to promote hemorrhoid regression and symptom resolution.
|
Placebo Group
n=150 Participants
Participants in this arm received oral placebo (identical in appearance, taste, and packaging to Nimsai Herbal) for 10 consecutive days.
Nimsai Herbal: This intervention consisted of an oral placebo, formulated to be identical in appearance, taste, and packaging to Nimsai Herbal. It was administered as one capsule per day for 10 consecutive days to ensure blinding and serve as a control for comparison.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=150 Participants
|
0 Participants
n=150 Participants
|
0 Participants
n=300 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
149 Participants
n=150 Participants
|
150 Participants
n=150 Participants
|
299 Participants
n=300 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=150 Participants
|
0 Participants
n=150 Participants
|
1 Participants
n=300 Participants
|
|
Age, Continuous
|
45.2 Years
STANDARD_DEVIATION 12.3 • n=150 Participants
|
45.7 Years
STANDARD_DEVIATION 12.5 • n=150 Participants
|
45.45 Years
STANDARD_DEVIATION 12.4 • n=300 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=150 Participants
|
78 Participants
n=150 Participants
|
156 Participants
n=300 Participants
|
|
Sex: Female, Male
Male
|
72 Participants
n=150 Participants
|
72 Participants
n=150 Participants
|
144 Participants
n=300 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Turkey
|
150 Participants
n=150 Participants
|
150 Participants
n=150 Participants
|
300 Participants
n=300 Participants
|
|
Hemorrhoid Grade at Baseline
Grade 2 Hemorrhoids
|
105 Participants
n=150 Participants
|
105 Participants
n=150 Participants
|
210 Participants
n=300 Participants
|
|
Hemorrhoid Grade at Baseline
Grade 3 Hemorrhoids
|
45 Participants
n=150 Participants
|
45 Participants
n=150 Participants
|
90 Participants
n=300 Participants
|
|
Composite Severity Score at Baseline
|
24.8 units on a scale
STANDARD_DEVIATION 6.7 • n=150 Participants
|
24.5 units on a scale
STANDARD_DEVIATION 6.5 • n=150 Participants
|
24.65 units on a scale
STANDARD_DEVIATION 6.6 • n=300 Participants
|
|
Overall Symptom VAS Score at Baseline
|
6.5 units on a scale
STANDARD_DEVIATION 1.9 • n=150 Participants
|
6.4 units on a scale
STANDARD_DEVIATION 1.8 • n=150 Participants
|
6.45 units on a scale
STANDARD_DEVIATION 1.85 • n=300 Participants
|
|
Participants with War Mode Hemorrhoids (via Parola Phenomenon)
|
60 Participants
n=150 Participants
|
57 Participants
n=150 Participants
|
117 Participants
n=300 Participants
|
|
Diabetes (%)
|
15 Participants
n=150 Participants
|
15 Participants
n=150 Participants
|
30 Participants
n=300 Participants
|
PRIMARY outcome
Timeframe: Day 10 (end of treatment period)Population: All randomized participants who completed the study (Full Analysis Set).
Hemorrhoid regression was defined as a reduction of at least one Goligher grade or a ≥75% reduction in composite hemorrhoid severity score by Day 10. (The Goligher Classification of Hemorrhoids is a 4-point scale (Grade I to IV) used for hemorrhoid severity, where higher scores indicate worse disease.)
Outcome measures
| Measure |
Nimsai Herbal Group
n=150 Participants
Participants in this arm received oral Nimsai Herbal (600 mg, one capsule per day) for 10 consecutive days.
|
Placebo Group
n=150 Participants
Participants in this arm received oral placebo (identical in appearance, taste, and packaging to Nimsai Herbal) for 10 consecutive days.
|
|---|---|---|
|
Hemorrhoid Regression Rate
|
117 Participants
|
33 Participants
|
Adverse Events
Nimsai Herbal Group
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nimsai Herbal Group
n=150 participants at risk
Participants in this arm received oral Nimsai Herbal (600 mg, one capsule per day) for 10 consecutive days.
|
Placebo Group
n=150 participants at risk
Participants in this arm received oral placebo (identical in appearance, taste, and packaging to Nimsai Herbal) for 10 consecutive days.
|
|---|---|---|
|
Gastrointestinal disorders
Mild GI discomfort
|
4.0%
6/150 • Number of events 6 • Adverse events were collected from randomization until the end of the study treatment period (Day 10), covering the entire intervention duration for each participant.
Adverse events were systematically collected at each study visit and through participant spontaneous reports. Each event's severity and relationship to the study intervention were assessed by blinded investigators, ensuring robust and unbiased safety data collection.
|
2.0%
3/150 • Number of events 3 • Adverse events were collected from randomization until the end of the study treatment period (Day 10), covering the entire intervention duration for each participant.
Adverse events were systematically collected at each study visit and through participant spontaneous reports. Each event's severity and relationship to the study intervention were assessed by blinded investigators, ensuring robust and unbiased safety data collection.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place