HemorrhoidPhase 3NAJ2NCT07669662
Nimsai Herbal for Grade 2-3 Hemorrhoids: A Quadruple-Blind Placebo-Controlled Mechanistic Trial
A Phase 3 study testing Nimsai Herbal in people with Hemorrhoid and Hemorrhoidal Disease, run by Nimsai Academia at 1 site in Turkey (Türkiye).
Trial summary
This randomized, quadruple-blind, placebo-controlled clinical trial evaluates the efficacy and safety of Nimsai Herbal, a proprietary oral phytotherapeutic formulation, in 50 participants aged 18-70 years with endoscopically confirmed Grade 2-3 internal hemorrhoids. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hemorrhoid, Hemorrhoidal Disease
- What is being tested?
- Nimsai Herbal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jun 2026to 2 Jul 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Endoscopically confirmed Grade 2 or 3 internal hemorrhoids
- History of hemorrhoidal symptoms persisting for more than 6 weeks prior to screening
- Age 18 to 70 years inclusive at time of informed consent
- Willingness and ability to provide written informed consent
- Willingness and ability to comply with all study procedures, schedules, and follow-up requirements
Who cannot join
- Diagnosis of Grade 1 or Grade 4 hemorrhoids
- Any known anorectal malignancy or suspicion of malignancy
- Active bleeding from sources other than hemorrhoids
- Currently pregnant or lactating women, or women of childbearing potential not using effective contraception
- Known hypersensitivity or allergy to any component of Nimsai Herbal or placebo
- Significant systemic diseases including severe cardiovascular disease, severe renal impairment, severe hepatic dysfunction, or uncontrolled diabetes mellitus (HbA1c > 9%)
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- Any medical or psychiatric condition that might compromise participant safety or data integrity
- Participation in another interventional clinical trial within 30 days prior to screening
- Use of concurrent treatments for hemorrhoids within 7 days prior to screening
- History of hemorrhoidectomy or other invasive hemorrhoid procedures within the last 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Nimsai Academia Clinical Research Center
Bursa
Cem Atabiner, 05324593292, info@nimsai.com
About this study
Official title: Quadruple-Blind, Placebo-Controlled, Parallel-Group Randomized Controlled Trial to Evaluate the Efficacy and Safety of Nimsai Herbal in Patients With Grade 2-3 Hemorrhoids
This randomized, quadruple-blind, placebo-controlled clinical trial evaluates the efficacy and safety of Nimsai Herbal, a proprietary oral phytotherapeutic formulation, in 50 participants aged 18-70 years with endoscopically confirmed Grade 2-3 internal hemorrhoids. Participants will be randomly assigned in a 1:1 ratio to receive either Nimsai Herbal (600 mg) or identical placebo once daily for 10 consecutive days. The primary endpoint is hemorrhoid regression at Day 10, defined as either a reduction in Goligher grade or a ≥75% reduction in composite hemorrhoid severity score. Secondary endpoints include change in symptom severity measured by Visual Analog Scale and complete symptom resolution rate. The study is designed as a mechanistic signal-detection investigation based on the War-Drill Model, which posits venous congestion as the primary initiating event in hemorrhoid pathogenesis.
Read the detailed description
This is a prospective, single-center, quadruple-blind, placebo-controlled, parallel-group randomized controlled trial designed as a mechanistic signal-detection study. The trial evaluates the War-Drill Model of hemorrhoid pathogenesis, which proposes that venous congestion, rather than primary vascular deformation, constitutes the indispensable initiating event in hemorrhoid formation. The model distinguishes two hemodynamic phenotypes: War Mode, associated with systemic inflammation and sustained venous congestion, and Drill Mode, characterized by hormonally mediated transient venous engorgement.
A total of 50 participants with endoscopically confirmed Grade 2-3 internal hemorrhoids and symptom duration exceeding 6 weeks will be randomized 1:1 to Nimsai Herbal (600 mg once daily) or matching placebo for 10 consecutive days. The study employs quadruple blinding, with participants, care providers, investigators, and outcomes assessors all masked to treatment assignment. An independent Data Safety Monitoring Board will provide ongoing safety oversight.
The primary outcome is hemorrhoid regression rate at Day 10, defined as either reduction in Goligher grade or ≥75% reduction in composite severity score. Secondary outcomes include mean change in self-reported symptom severity (VAS) and complete symptom resolution rate. Safety outcomes include incidence of mild gastrointestinal discomfort, serious adverse events, and withdrawals due to adverse events. Diabetic participants will be specifically monitored for transient diarrhea during Days 1-3.
The Parola Phenomenon, a patient-reported clinical indicator, will be assessed at baseline to stratify participants into War Mode and Drill Mode phenotypes for exploratory subgroup analyses.
The trial is prospectively registered on ClinicalTrials.gov and approved by the Nimsai Academia Ethics Committee. Written informed consent will be obtained from all participants. The complete study protocol, statistical analysis plan, and de-identified individual participant data will be made publicly available through the Dryad Digital Repository.
- Conditions
- Hemorrhoid, Hemorrhoidal Disease
- Being tested
- Nimsai Herbal, Placebo
- Keywords
- venous stasis, War-Drill Model, Parola Phenomenon, phytotherapy, Nimsai Herbal, quadruple-blind
- Medical subject headings
- Hemorrhoids, Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nimsai HerbalDietary supplement
600 mg oral capsule taken once daily. Contains a proprietary blend of Centella asiatica extract, Curcuma longa extract, and Piper nigrum extract.
PlaceboOther
Identical-appearing oral capsule containing inert ingredients, matched for taste and packaging.
| Study group | Role | What they receive |
|---|---|---|
| Nimsai Herbal Group | Experimental | Participants in this arm will receive Nimsai Herbal capsules (600 mg) orally once daily for 10 consecutive days. Nimsai Herbal is a proprietary oral phytotherapeutic formulation. The product is approved as a food supplement by the Turkish Ministry of Agriculture and Forestry (TEG Approval No: 015473-13.12.2022). Receives: Dietary Supplement: Nimsai Herbal |
| Placebo Group | Placebo comparator | Participants in this arm will receive placebo capsules identical in appearance, taste, and packaging to Nimsai Herbal, administered orally once daily for 10 consecutive days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemorrhoid Regression Rate
Percentage of participants achieving a clinical response at Day 10, defined as either a reduction in Goligher grade or a ≥75% reduction in composite hemorrhoid severity score from baseline. The composite score is the sum of clinician-assessed scores for pain, bleeding, itching, and swelling, each rated on a 0-10 Visual Analog Scale (total range 0-40).
Measured: Day 10
Secondary outcomes (2)
Visual Analog Scale Symptom Score Change
Mean change from baseline in self-reported overall hemorrhoid symptom severity at Day 10, measured on a 0-10 Visual Analog Scale (0 = no symptoms, 10 = most severe symptoms).
Measured: Baseline to Day 10
Symptom Resolution Rate
Percentage of participants achieving complete resolution of all baseline hemorrhoid symptoms (composite severity score = 0) at Day 10.
Measured: Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start22 Jun 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion2 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nimsai Academia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07669662
- Sponsor's protocol ID
- NA-2026-01
- Acronym
- NAJ2
- Status last verified
- Jun 2026
- First submitted
- 20 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the reported results, including baseline characteristics, primary and secondary outcome data, and safety data.
Publications
Atabiner C. The War-Drill Model of Hemorrhoid Pathogenesis. Research Square. 2025. doi:10.21203/rs.3.rs-6607959/v1
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadruple-Blind, Placebo-Controlled, Parallel-Group Randomized Controlled Trial to Evaluate the Efficacy and Safety of Nimsai Herbal in Patients With Grade 2-3 Hemorrhoids
- ClinicalTrials.gov ID
- NCT07669662
- Acronym / sponsor ID
- NAJ2 / NA-2026-01
- Conditions
- Hemorrhoid, Hemorrhoidal Disease
- Keywords
- venous stasis, War-Drill Model, Parola Phenomenon, phytotherapy, Nimsai Herbal, quadruple-blind
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nimsai AcademiaUniversity, hospital or other
- Study start
- 22 Jun 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 2 Jul 2026 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, quadruple-blind, placebo-controlled clinical trial evaluates the efficacy and safety of Nimsai Herbal, a proprietary oral phytotherapeutic formulation, in 50 participants aged 18-70 years with endoscopically confirmed Grade 2-3 internal hemorrhoids. Participants will be randomly assigned in a 1:1 ratio to receive either Nimsai Herbal (600 mg) or identical placebo once daily for 10 consecutive days. The primary endpoint is hemorrhoid regression at Day 10, defined as either a reduction in Goligher grade or a ≥75% reduction in composite hemorrhoid severity score. Secondary endpoints include change in symptom severity measured by Visual Analog Scale and complete symptom resolution rate. The study is designed as a mechanistic signal-detection investigation based on the War-Drill Model, which posits venous congestion as the primary initiating event in hemorrhoid pathogenesis.
Detailed description
This is a prospective, single-center, quadruple-blind, placebo-controlled, parallel-group randomized controlled trial designed as a mechanistic signal-detection study. The trial evaluates the War-Drill Model of hemorrhoid pathogenesis, which proposes that venous congestion, rather than primary vascular deformation, constitutes the indispensable initiating event in hemorrhoid formation. The model distinguishes two hemodynamic phenotypes: War Mode, associated with systemic inflammation and sustained venous congestion, and Drill Mode, characterized by hormonally mediated transient venous engorgement.
A total of 50 participants with endoscopically confirmed Grade 2-3 internal hemorrhoids and symptom duration exceeding 6 weeks will be randomized 1:1 to Nimsai Herbal (600 mg once daily) or matching placebo for 10 consecutive days. The study employs quadruple blinding, with participants, care providers, investigators, and outcomes assessors all masked to treatment assignment. An independent Data Safety Monitoring Board will provide ongoing safety oversight.
The primary outcome is hemorrhoid regression rate at Day 10, defined as either reduction in Goligher grade or ≥75% reduction in composite severity score. Secondary outcomes include mean change in self-reported symptom severity (VAS) and complete symptom resolution rate. Safety outcomes include incidence of mild gastrointestinal discomfort, serious adverse events, and withdrawals due to adverse events. Diabetic participants will be specifically monitored for transient diarrhea during Days 1-3.
The Parola Phenomenon, a patient-reported clinical indicator, will be assessed at baseline to stratify participants into War Mode and Drill Mode phenotypes for exploratory subgroup analyses.
The trial is prospectively registered on ClinicalTrials.gov and approved by the Nimsai Academia Ethics Committee. Written informed consent will be obtained from all participants. The complete study protocol, statistical analysis plan, and de-identified individual participant data will be made publicly available through the Dryad Digital Repository.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nimsai Herbal Group | Experimental | Dietary Supplement: Nimsai HerbalParticipants in this arm will receive Nimsai Herbal capsules (600 mg) orally once daily for 10 consecutive days. Nimsai Herbal is a proprietary oral phytotherapeutic formulation. The product is approved as a food supplement by the Turkish Ministry of Agriculture and Forestry (TEG Approval No: 015473-13.12.2022). |
| Placebo Group | Placebo comparator | Other: PlaceboParticipants in this arm will receive placebo capsules identical in appearance, taste, and packaging to Nimsai Herbal, administered orally once daily for 10 consecutive days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Endoscopically confirmed Grade 2 or 3 internal hemorrhoids
- History of hemorrhoidal symptoms persisting for more than 6 weeks prior to screening
- Age 18 to 70 years inclusive at time of informed consent
- Willingness and ability to provide written informed consent
- Willingness and ability to comply with all study procedures, schedules, and follow-up requirements
Key exclusion criteria (10 listed)
- Diagnosis of Grade 1 or Grade 4 hemorrhoids
- Any known anorectal malignancy or suspicion of malignancy
- Active bleeding from sources other than hemorrhoids
- Currently pregnant or lactating women, or women of childbearing potential not using effective contraception
- Known hypersensitivity or allergy to any component of Nimsai Herbal or placebo
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nimsai Herbal600 mg oral capsule taken once daily. Contains a proprietary blend of Centella asiatica extract, Curcuma longa extract, and Piper nigrum extract. | Dietary supplement | Nimsai Herbal Group |
| PlaceboIdentical-appearing oral capsule containing inert ingredients, matched for taste and packaging. | Other | Placebo Group |
Primary outcome
Hemorrhoid Regression Rate
Time frame: Day 10
Percentage of participants achieving a clinical response at Day 10, defined as either a reduction in Goligher grade or a ≥75% reduction in composite hemorrhoid severity score from baseline. The composite score is the sum of clinician-assessed scores for pain, bleeding, itching, and swelling, each rated on a 0-10 Visual Analog Scale (total range 0-40).
2 secondary outcomes
Visual Analog Scale Symptom Score Change
Time frame: Baseline to Day 10
Symptom Resolution Rate
Time frame: Day 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- BackgroundAtabiner C. The War-Drill Model of Hemorrhoid Pathogenesis. Research Square. 2025. doi:10.21203/rs.3.rs-6607959/v1
- Nimsai Academia Research InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the reported results, including baseline characteristics, primary and secondary outcome data, and safety data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nimsai Herbal in people with Hemorrhoid and Hemorrhoidal Disease, run by Nimsai Academia at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cem Atabiner (05324593292, info@nimsai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemorrhoid Regression Rate (time frame: Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07669662, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.