INVESTIGATION OF THE ANTI-NEOPLASTIC EFFECT OF TRISHUL (AYURVEDIC AGENT) ON TUMOUR REGRESSION OF RECTAL CANCER- A PILOT STUDY

NCT07430696 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: Anticancer effect of Trishul
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Ayurvedic medicines are used extensively in Asia both for benign as well as malignant disease. Despite their widespread use there is scant scientific evidence to prove efficacy. There are anecdotal reports of effectiveness. Patients are often referred to ayurvedic physicians when all other options have been exhausted. We, at the university of Kelaniya , are planning a randomised double blind placebo controlled study to investigate the anticancer effects of an anticancer ayurvedic drug Trishul in patients with rectal cancer. Patients after discussion at the multidisciplinary discussion will be randomised into two groups. One group will receive the active drg and the other will receive matching placebo. This will be additional to the standard treatment advised by the multidisciplinary team. Treatment/Placebo will be started 4 weeks preoperatively and continued for 24 weeks postoperatively. Patients will be followed up in a standard manner. Evidence of any adverse effects, disease recurrence either locally or at a distant site will be recorded. Overall survival and disease free survival will be the primary endpoints.

Conditions

Efficacy of Trishul

Outcome Measures

Primary Outcomes (2)

• Overall survival

  5 years

• Overall survival

  overall survival in the treatment arm and placebo arm will be measured

  5 years

Study Arms (2)

treatment arm - Trishul caps

EXPERIMENTAL

Patients in the treatment arm will recive 750 mg trishul twice daily orally

Drug: Trishul 750 mg bd orally

Matching placebo

PLACEBO COMPARATOR

Drug: Trishul 750 mg bd orally

Interventions

Trishul 750 mg bd orally DRUG

Patients randomised to receive Trishul will be give 750 mg of the drug orally ywice daily

Matching placebo; treatment arm - Trishul caps

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kelaniya: lead

Central Study Contacts

Pramodh Chandrasinghe, PhD FRCS

CONTACT

+94773184301; pramodh@kln.ac.lk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Study Design A randomized, placebo-controlled phase II trial designed to evaluate the efficacy and safety of an Ayurvedic preparation (Trishul) combined with preoperative chemoradiotherapy versus chemoradiotherapy alone in patients with rectal cancer. A total of 40 eligible patients will be randomized in a 1:1 ratio to either the control group (standard chemoradiotherapy) or the intervention group (standard chemoradiotherapy plus Ayurvedic preparation). Randomization will be stratified by tumour stage (T3 vs T4), gender, patient age (\<40 years vs ≥40 years), and by tumour grade on biopsy specimens (Grade 1 and 11 vs Grade 111). Treatment will be administered over a standard 5-6week course of preoperative therapy, followed by surgical resection according to institutional protocols. In the ayurveda arm, ayurveda medication will be administered alongside neoadjuvant therapy and continued uninterruted for atotal of 12 weeks
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gastrointestinal surgery

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 24, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02