An interventional study of Nimsai Herbal and Placebo in Hemorrhoids and Hemorrhoidal Disease, sponsored by Nimsai Academia. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-07-31.
Sponsored by Nimsai Academia · Not applicable, Interventional, and Treatment
This study investigated a new understanding of hemorrhoid formation and evaluated a novel systemic treatment. For 200 years, hemorrhoids were conventionally understood as isolated swollen veins. However, our new "War-Drill Model" proposes that hemorrhoids are primarily caused by blood pooling (venous congestion) in the anal region, which then secondarily leads to vascular deformation. This congestion is hypothesized to arise from either underlying health issues ("War Mode") or natural physiological and hormonal changes ("Drill Mode"). We conducted a double-blind, placebo-controlled randomized controlled trial on 300 patients with Grade 2-3 hemorrhoids to evaluate the efficacy and safety of Nimsai Herbal. This study explores the potential for "War Mode" hemorrhoids to serve as an early warning sign for other serious underlying conditions and aims to validate a novel systemic therapeutic approach.
The current understanding of hemorrhoid pathogenesis has remained largely unchanged for over two centuries, positing hemorrhoids primarily as isolated venous dilatations or prolapses. This traditional view, however, fails to adequately explain the high recurrence rates post-treatment, the limited efficacy of topical agents, and the often-debilitating symptomatology. Our extensive research, culminating in the "War-Drill Model" and the "Sine Qua Non Hypothesis," fundamentally challenges this conventional paradigm. We propose that hemorrhoids are not primarily structural abnormalities but rather a manifestation of underlying venous congestion, which then secondarily leads to vascular deformation and associated symptoms. This congestion acts as the indispensable (sine qua non) prerequisite for the development of both symptomatic and asymptomatic hemorrhoidal disease.
The "War-Drill Model" further categorizes this venous congestion based on its etiology:
War Mode Hemorrhoids: These are hypothesized to arise from chronic or passive venous congestion triggered by an underlying systemic or local inflammatory process or pathology. Examples include inflammatory bowel diseases (Crohn's disease, ulcerative colitis), anal fissures, rectal polyps, liver diseases causing portal hypertension, and various other systemic conditions affecting vascular flow or integrity. Crucially, "War Mode" hemorrhoids may serve as a critical "biological early-warning system," prompting investigations that could lead to the early diagnosis of up to 20 distinct and potentially severe internal diseases.
Drill Mode Hemorrhoids: These are hypothesized to be transient vascular engorgements resulting from physiological hormonal fluctuations, typically observed during periods of significant endocrine change such as adolescence, pregnancy, lactation, menopause, and andropause. These episodes are often self-limiting, resolving as hormonal balance stabilizes.
To validate a systemic therapeutic approach based on this new model, we conducted a double-blind, placebo-controlled, parallel-group Randomized Controlled Trial (RCT) (Protocol ID: NA-2024-01). The study enrolled 300 participants aged 18-70 years with endoscopically confirmed Grade 2-3 internal hemorrhoids and a history of symptoms for over 6 weeks. Participants were randomized to receive either Nimsai Herbal (a novel systemic botanical formulation, 600 mg daily) or an identical placebo for 10 consecutive days.
The primary outcome measure was hemorrhoid regression rate, defined as a reduction of at least one Goligher grade by Day 10, assessed via anoscopic examination and clinical evaluation. Secondary outcomes included incidence of adverse events. The study utilized the "Parola Phenomenon," a simple clinical maneuver designed by Atabiner, as part of patient assessment, aiming to differentiate War Mode from Drill Mode hemorrhoids.
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's enrollment of 300 is above the median of 100 across 183 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Nimsai Academia is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Endoscopically confirmed Grade 2 or 3 internal hemorrhoids.
History of hemorrhoidal symptoms >6 weeks.
Age 18-70 years at the time of enrollment.
Provided written prior to any study-related procedures.
Willingness and ability to comply with all study procedures and follow-up visits.
Exclusion Criteria:
Grade 1 or 4 hemorrhoids.
Any known anorectal or suspicion of malignancy.
Pregnancy or lactation.
Known or allergy to Nimsai Herbal components or placebo ingredients.
Significant systemic diseases (e.g., severe cardiovascular, renal, hepatic, or hematological disorders) that could affect study participation or safety.
Participation in another clinical trial within 30 days prior to screening.
Any condition that, in the opinion of the investigator, might compromise the safety of the participant or the integrity of the study data.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm received oral Nimsai Herbal (600 mg, one capsule per day) for 10 consecutive days.
Dietary Supplement: Nimsai Herbal
Participants in this arm received oral placebo (identical in appearance, taste, and packaging to Nimsai Herbal) for 10 consecutive days.
Dietary Supplement: Placebo
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.
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.
Hemorrhoid Regression Rate
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.)
Time frame: Day 10 (end of treatment period)
| Milestone | Nimsai Herbal Group | Placebo Group |
|---|---|---|
| Started | 150 | 150 |
| Completed | 150 | 150 |
| Not completed | 0 | 0 |
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.)
| Participants | Nimsai Herbal Group | Placebo Group |
|---|---|---|
| Hemorrhoid Regression Rate | 117 | 33 |
Collected over Adverse events were collected from randomization until the end of the study treatment period (Day 10), covering the entire intervention duration for each participant.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nimsai Herbal Group | 0/150 (0%) | 0/150 (0%) | 6/150 (4%) |
| Placebo Group | 0/150 (0%) | 0/150 (0%) | 3/150 (2%) |
| Event | Nimsai Herbal Group | Placebo Group |
|---|---|---|
| Mild GI discomfortGastrointestinal disorders | 6/150 | 3/150 |
All randomized participants (N=300) were included in the baseline analysis population, as complete baseline data were obtained for all individuals.
| Age, Categorical(Participants) | Nimsai Herbal Group | Placebo Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 149 | 150 | 299 |
| >=65 years | 1 | 0 | 1 |
| Age, Continuous(Years) | Nimsai Herbal Group | Placebo Group | Total |
|---|---|---|---|
| Mean | 45.2 ± 12.3 | 45.7 ± 12.5 | 45.45 ± 12.4 |
| Sex: Female, Male(Participants) | Nimsai Herbal Group | Placebo Group | Total |
|---|---|---|---|
| Female | 78 | 78 | 156 |
| Male | 72 | 72 | 144 |
| Race and Ethnicity Not Collected(Participants) | Nimsai Herbal Group | Placebo Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Nimsai Herbal Group | Placebo Group | Total |
|---|---|---|---|
| Turkey | 150 | 150 | 300 |
| Hemorrhoid Grade at Baseline(Participants) | Nimsai Herbal Group | Placebo Group | Total |
|---|---|---|---|
| Grade 2 Hemorrhoids | 105 | 105 | 210 |
| Grade 3 Hemorrhoids | 45 | 45 | 90 |
| Composite Severity Score at Baseline(units on a scale) | Nimsai Herbal Group | Placebo Group | Total |
|---|---|---|---|
| Mean | 24.8 ± 6.7 | 24.5 ± 6.5 | 24.65 ± 6.6 |
| Overall Symptom VAS Score at Baseline(units on a scale) | Nimsai Herbal Group | Placebo Group | Total |
|---|---|---|---|
| Mean | 6.5 ± 1.9 | 6.4 ± 1.8 | 6.45 ± 1.85 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Individual participant data (IPD) that underlie the results reported in this article, after de-identification, will be available upon reasonable request to qualified researchers who submit a methodologically sound proposal. Data will be shared through a secure platform, subject to a data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Individual participant data and supporting information will be available starting 6 months after the official publication of the primary manuscript in a peer-reviewed journal. The data will remain accessible indefinitely thereafter, or for as long as ethically and legally permissible under relevant data privacy regulations and institutional policies.
Access criteria: Access to de-identified individual participant data (IPD) and supporting documentation (including the study protocol, statistical analysis plan, and informed consent form) will be granted to qualified researchers. Researchers must submit a methodologically sound and ethically approved research proposal that aligns with the original study's objectives or adds significant scientific value. Access will be provided through a secure, controlled-access platform, requiring a signed Data Use Agreement (DUA) between the requesting institution and Nimsai Academia. This agreement will outline strict terms for data use, confidentiality, and proper attribution, ensuring compliance with all applicable privacy regulations (e.g., GDPR, HIPAA equivalents). Data will be used solely for non-commercial scientific research purposes.
Data sharing details ↗ · kecioutdoor.com.tr
Ran from Oct 2021 to primary completion in Oct 2021, 0 months.
Results were first posted in Jul 2025, 3 years 9 months after primary completion.
Of 65 non-industry interventional studies with no phase under Hemorrhoids, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's 0 months is below that.
Counting every sponsor, half of 70 studies reached it within 23 months; a quarter within 10 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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