A Phase 3 interventional study of Nimsai Herbal and Placebo in Hemorrhoid and Hemorrhoidal Disease, sponsored by Nimsai Academia. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Nimsai Academia · Phase 3, Interventional, and Treatment
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.
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.
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's planned enrollment of 50 is below 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.
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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.
History of hemorrhoidal symptoms persisting for more than 6 weeks prior to screening
Age 18 to 70 years inclusive at time of
Willingness and ability to provide written informed consent
Willingness and ability to comply with all study procedures, schedules, and follow-up requirements
Exclusion Criteria:
Any known anorectal or suspicion of malignancy
Active bleeding from sources other than hemorrhoids
Currently pregnant or lactating women, or women of not using effective
Known 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 ( > 9%)
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
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Dietary Supplement: Nimsai Herbal
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.
Other: Placebo
600 mg oral capsule taken once daily. Contains a proprietary blend of Centella asiatica extract, Curcuma longa extract, and Piper nigrum extract.
Identical-appearing oral capsule containing inert ingredients, matched for taste and packaging.
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).
Time frame: Day 10
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).
Time frame: 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.
Time frame: Day 10
Incidence of Mild Gastrointestinal Discomfort
Percentage of participants reporting mild gastrointestinal adverse events (nausea, bloating, dyspepsia) during the 10-day intervention period.
Time frame: Baseline to Day 10
Incidence of Serious Adverse Events
Percentage of participants experiencing serious adverse events as defined by ICH GCP guidelines during the 10-day intervention period.
Time frame: Baseline to Day 10
Incidence of Transient Diarrhea in Diabetic Participants
Number of diabetic participants experiencing transient diarrhea resolving spontaneously within 24-48 hours during the first three days of the intervention.
Time frame: Days 1-3
Plan to share: Yes — De-identified individual participant data underlying the reported results, including baseline characteristics, primary and secondary outcome data, and safety data.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Starting 6 months after publication of the primary manuscript in a peer-reviewed journal. Data will remain accessible indefinitely thereafter, or for as long as ethically and legally permissible under relevant data privacy regulations.
Access criteria: Qualified researchers who submit a methodologically sound and ethically approved research proposal. Access requires a signed Data Use Agreement between the requesting institution and Nimsai Academia. Data will be shared through a secure controlled-access platform and used solely for non-commercial scientific research purposes.
Data sharing details ↗ · doi.org
Start is estimated for Jun 2026; primary completion for Jul 2026, 0 months later.
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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