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Ancient herb meets modern science: can trishul fight rectal cancer?

NCT ID NCT07430696

Disease control Sponsor: University of Kelaniya Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests whether an Ayurvedic drug called Trishul can help shrink rectal tumors and improve survival. Forty adults with advanced rectal cancer will receive either Trishul or a placebo pill, in addition to their standard treatment (chemo-radiation and surgery). The study is double-blind and placebo-controlled, meaning neither patients nor doctors know who gets the real drug. The main goal is to see if Trishul improves overall survival and disease-free survival over 24 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Trishul (Ayurvedic drug)
What this could lead to
If it works, this could point toward a safe, plant-based add-on treatment to improve survival in rectal cancer.
What could go wrong
This is a very small early pilot study (40 people). The drug is unproven, and results may show no benefit over placebo. Side effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria:• Adults aged over18 years, stratified for \<40 vs. \>40 years. * Histologically confirmed diagnosis of adenocarcinoma of the rectum stratified for grade of tumour of biopsy samples (Grade 1 and 11 vs 111) * Tumour classified as clinical stage T3-T4 and/or node-positive (N1-N2) without distant metastases (M0), based on MRI or CT. * Suitable for preoperative chemoradiotherapy and surgical resection. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (See appendix) * Normal haematological, renal, and hepatic serum biochemistry. * Ability to provide informed consent. Exclusion Criteria:• Evidence of distant metastases (M1 disease). * Prior pelvic radiotherapy, chemotherapy, or Ayurvedic therapy targeting cancer. * Known allergy or intolerance to medication. * Inflammatory bowel disease or other significant gastrointestinal disorders. * Pregnant or breastfeeding women. * Concurrent participation in another interventional clinical trial. * Any condition deemed by the investigator to interfere with study participation.

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Conditions

The condition(s) this trial relates to.

rectal cancer rectum adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Efficacy of trishul

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.