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Evaluate the effect of Nutraceutical Product (Onconeem) in patients with Colorectal Cancer

ABSTRACT: Intervention1: Onconeem: Onconeem 100 mg capsules will be taken twice daily along with SOC (palliative chemotherapy /radiotherapy of investigators choice) for a duration of 84 days Control Intervention1: Onconeem matching placebo: The placebo will be taken twice daily along with SOC (e.g., palliative chemotherapy/radiotherapy of investigator choice) for a duration of 84 days Primary outcome(s): Improvement in Quality of life (measured using FACT-G questionnaire) from baseline till End of treatment (EOT)Timepoint: Day 84 Study Design: Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded

DISEASE(S): Malignant Neoplasm Of Colon

PROVIDER: 30959 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Terminalia arjuna (Roxb.) Wight & Arn., a well known Traditional medicine an. popularly known as Arjuna, has a long antiquity of its role as a cardiac stimulant, and has been stipulated in the treatment of hypercholesterolemia, heart failure and atherosclerosis. The present study was carried out to access the effects of Terminalia arjuna as an adjuvant therapy in angiographically proven patients with stable coronary artery disease who were on conventional medications. The goal of the study was to establish whether Terminalia arjuna exerts beneficial effects in targetting disease signatures which remain unresponsive to the standard therapies currently employed in the clinics. The present study scientifically validates the therapeutic effects of this medicinal plant as an adjuvant therapy along with conventional drugs routinely used in the clinics for prevention and treatment of coronary artery disease. To access the effect of T.arjuna, a placebo-controlled, double blind randomized study was carried out in 100 angiographically proven non-diabetic patients with coronary artery disease having disease more than 3 months prior to their enrollment and using any combination of cardiac-related medications including ASA, ACEIs, ARBs, β-blockers and statins (Trial Registration Number : REF/2013/03/004810). Out of total 100 patients, 50 patients were on drug A and 50 patients were on drug B for a total duration of 6 months (Follow-up at 3 and 6 months). Both Drug as well as placebo was given in the form of capsule (500mg) provided by The Himalaya Drug Company, Bangalore. Method of concealment was through coded identical containers. All the participants, investigator, outcome Assessor and data-entry operator were blinded during the whole study. Micro-array was performed in 2 randomly selected patients in each sub-group i.e. Terminalia arjuna or Placebo at 3 and 6 months respectively. RNA extraction and hybridization was carried out using Affymetrix microarrays. Differential expression of genes in T.arjuna-treated and Placebo groups was studied to understand the specificity, efficacy and mechanism of action of T.arjuna.

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Evaluate the effect of Nutraceutical Product (Onconeem) in patients with Colorectal Cancer

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