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Evaluation of Malva Sylvestris. formulation on Radiation proctitis

ABSTRACT: Intervention 1: In the intervention group patient should use sachet of Malva, 12 mg in 3 dosage that should brewed in boiled water, from first day of radiation until end of that.(each pocket is 4 g). Intervention 2: All patients in control group take powder of placebo which is designed for this study in 4 mg packets in three dosages a day orally with a glass of hot water.;Prevention;Placebo;In the intervention group patient should use sachet of Malva, 12 mg in 3 dosage that should brewed in boiled water, from first day of radiation until end of that.(each pocket is 4 g);All patients in control group take powder of placebo which is designed for this study in 4 mg packets in three dosages a day orally with a glass of hot water. Primary outcome(s): Anal Burning. Timepoint: Every 3 weeks. Method of measurement: visual analog scale 0-10.;Diarrhea. Timepoint: every 3 week. Method of measurement: visual analog scale 0-10.;Fecal incontinence. Timepoint: every 3 weeks. Method of measurement: visual analog scale.;Fecal urgency. Timepoint: every 3 weeks. Method of measurement: visual analog scale.;Anal bleeding. Timepoint: every 3 weeks. Method of measurement: visual analog scale.;Excretion of mucous. Timepoint: every 3 weeks. Method of measurement: visual analog scale. Study Design: Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.

DISEASE(S): Radiation Proctitis

PROVIDER: 2479569 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Intervention 1: Intervention group: Patients with colorectal cancer, stage 4 which receive chemotherapy and vaccine. The allogene vaccine (including three colon cancer cell lines) will be injected in two periods. The first period consists of three consecutive doses: the first dose will be injected one week after diagnosis /surgery, the following two doses will be injected with a week interval. One week after the third injection, chemotherapy will begin. After the first period, chemotherapy begins and continues for six months. The second period of the vaccine starts one month after chemotherapy and includes three consecutive vaccine doses with a distance of one week. Chemotherapy begins and continues two weeks after the sixth injection. 300 million tumor cells (108 cells from each cancer cell line) with 1 million BCG organisms are injected intradermally in the first and second injections. The third, fourth, fifth, and sixth injections contain 300 million irradiated tumor cells. Intervention 2: Control group: Patients with colorectal cancer, stage 4 which receive Chemotherapy treatment 5 weeks after diagnosis /surgery. Primary outcome(s): Measuring the levels of CA19-9. Timepoint: 6 months after the last vaccination. Method of measurement: via Elisa method.;Measuring the levels of CEA. Timepoint: 6 months after the last vaccination. Method of measurement: via Elisa method.;Measuring the levels of alanine aminotransferase. Timepoint: 6 months after the last vaccination. Method of measurement: via Elisa method.;Measuring the levels of aspartate aminotransferase. Timepoint: 6 months after the last vaccination. Method of measurement: via Elisa method.;Measuring the levels of alkaline phosphatase. Timepoint: 6 months after the last vaccination. Method of measurement: via Elisa method.;Measuring the levels of glutamyl tarnspeptidase. Timepoint: 6 months after the last vaccination. Method of measurement: via Elisa method.;Investigation of tumor formation. Timepoint: 6 months after the last vaccination. Method of measurement: via colonoscopy. Study Design: Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.

Project description:Intervention 1: Stinging nettle tablet, produced in the company of barijessence, 400 mg tablet, three times a day for 3 months in intervention group. Intervention 2: Placebo, tablets containing starch, produced in Tehran University of Medical Sciences, 400 mg tablet, three times a day for 3 months in control group.;Treatment - Drugs;Placebo;Stinging nettle tablet, produced in the company of barijessence, 400 mg tablet, three times a day for 3 months in intervention group;Placebo, tablets containing starch, produced in Tehran University of Medical Sciences, 400 mg tablet, three times a day for 3 months in control group. Primary outcome(s): Erythrocyte Sedimentation Rate. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Automation Method (mm/h).;High- sensitivity C- reactive protein. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is mg/dl.;Quality of life. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Inflammatory Bowel Disease Questionnaire-Short Form.;White blood cell. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Flow cytometry Method (cells/ml).;Superoxide dismutase. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is ng/ml.;Platelet. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: Flow cytometry Method (cells/µl).;Fecal calprotectin. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is µg/g.;Tumor necrosis factor alpha. Timepoint: At the Beginning of intervention and 3 months after Beginning of the intervention. Method of measurement: It is measured by kit (ELISA methods) and the unit is ng/ml. Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization is done by stratified blocked randomization. Placebo in the form of a double-blind to the participants in this study given. Researchers and patients are blinded to the treatment and placebo groups.

Project description:Intervention 1: Intervention group: Subjects in the intervention group receive curcumin-piperine capsules (daily intake of 500 mg curcumin plus 5 mg piperine) for 8 weeks (n=36). The participants take one capsule every day, which was contained in an unlabeled bottle. Capsules are from Sami Labs company (Bangalore, India). Intervention 2: Control group: Placebo capsules are prepared by a similar company and are similar to the curcumin capsules regarding the color, shape and size. The control group receive a placebo capsule containing lactose plus 5 mg piperine for a period of 8 weeks (n=36). The participants take one capsule every day, which was contained in an unlabeled bottle. Capsules are from Sami Labs company (Bangalore, India). Primary outcome(s): Tumor necrosis factor alpha. Timepoint: Before the intervention and 8 weeks after taking drug or placebo. Method of measurement: Sandwich and competitive chemiluminescence immunoassays.;Interleukin 6. Timepoint: Before the intervention and 8 weeks after taking drug or placebo. Method of measurement: Sandwich and competitive chemiluminescence immunoassays.;Total quality of life score. Timepoint: Before the intervention and 8 weeks after taking drug or placebo. Method of measurement: Using EORTC QLQ questionnaire. Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly assigned to one of the treatment groups based on random allocation sequence generated by a statistician: 1) Drug: a group receiving liposomal curcumin capsules (500 mg/day) for 8 weeks (n=36), 2) Placebo: the control group who taking a placebo capsule for a period of 8 weeks (n=36).The tables of the Fleiss book were used to generate the random allocation sequence. The allocation scheme was consecutively numbered in envelopes which opened sequentially by an independent person, not involved in the study, Blinding description: All volunteers, care providers and statistician were blinded after assignment to intervention. So that, the capsules containers were coded as A and B by a non-researcher person and remained confidential until statistical analysis. The placebo capsules were similar to the drugs regarding the weight and c

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Evaluation of Malva Sylvestris. formulation on Radiation proctitis

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