Investigating the effect of Byolic CC product consumption along with standard treatment in patients with colon cancer

Comparison of clinical status and immune responses of patients with colon cancer under standard treatment with patients receiving a product containing the herbal immunomodulator Byolic CC along with standard treatment

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240304061158N3

Enrollment

Registered

2024-07-25

Start date

2024-07-10

Completion date

Unknown

Last updated

2024-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colon cancer. Malignant neoplasm of colon

Interventions

Intervention 1: Intervention group: Patients with colon cancer receive Byolic CC capsules produced by Behpad Tab for 2 months, once a day, preferably with meals along with their standard treatment. In

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Diagnosis of colon cancer in colonoscopy with histopathological examination

Exclusion criteria

Exclusion criteria: Necessity of surgery or emergency operation or radiotherapy Active infection Systemic immune disorders history of inflammatory bowel diseases pregnancy

Design outcomes

Primary

Measure	Time frame
Karnofsky performance scale index. Timepoint: The Karnofsky index will be calculated on day zero at the beginning of the study and day 60 at the end of the study. Method of measurement: The Karnofsky index is measured using physical examination checklist.	—

Secondary

Measure	Time frame
CEA index of colon cancer patients. Timepoint: The CEA index will be assessed on day zero at the beginning of the study and on day 60 at the end of the study. Method of measurement: The CEA index is calculated using a clinical examination checklist.;Counting of T CD3 CD8 and T CD4 cells. Timepoint: Counting of T CD8 CD3 and T CD4 cells will be done on day zero at the beginning of the study and on day 60 at the end of the study. Method of measurement: Counting of T CD8 CD3 and T CD4 cells will be done using flow cytometry.;Regulatory and inflammatory cytokines assay. Timepoint: Cytokines will be measured on day zero at the beginning of the study and day 60 at the end of the study. Method of measurement: Cytokines IL-10, TGF-ß, TNF, IL-6 will be measured using ELISA technique.;Cell cycle checkpoints mRNA expression. Timepoint: The expression of cell cycle checkpoint genes is measured on day 0 at the beginning of the study and on day 60 at the end of the study. Method of measurement: Gene expression measurement of cell cycle checkpoints (CTLA-4, PD-1) is performed by Real-time PCR technique.	—

Measure

Time frame

CEA index of colon cancer patients. Timepoint: The CEA index will be assessed on day zero at the beginning of the study and on day 60 at the end of the study. Method of measurement: The CEA index is calculated using a clinical examination checklist.;Counting of T CD3 CD8 and T CD4 cells. Timepoint: Counting of T CD8 CD3 and T CD4 cells will be done on day zero at the beginning of the study and on day 60 at the end of the study. Method of measurement: Counting of T CD8 CD3 and T CD4 cells will be done using flow cytometry.;Regulatory and inflammatory cytokines assay. Timepoint: Cytokines will be measured on day zero at the beginning of the study and day 60 at the end of the study. Method of measurement: Cytokines IL-10, TGF-ß, TNF, IL-6 will be measured using ELISA technique.;Cell cycle checkpoints mRNA expression. Timepoint: The expression of cell cycle checkpoint genes is measured on day 0 at the beginning of the study and on day 60 at the end of the study. Method of measurement: Gene expression measurement of cell cycle checkpoints (CTLA-4, PD-1) is performed by Real-time PCR technique.

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Countries

Iran (Islamic Republic of)

Contacts

Public Contactrahimlou bahman

Immunoregulation Research Center

bahman.rahimloo.73@gmail.com+98 21 6641 9712

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026