Studying of Black Seed effect on colorectal cancer
Ontology highlight
ABSTRACT:
DISEASE(S): Malignant Neoplasm Of Rectum,Malignant Neoplasm Of Rectosigmoid Junction,Condition 1: Colorectal Cancer. Condition 2: Colon Cancer. Condition 3: Rectum Cancer,Malignant Neoplasm Of Colon
PROVIDER: 2496470 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:Intervention 1: L-Lisyne powder 1.5g twice per day in combination with drugs of chemical therapy for patients in treatment group.
The duration of treatment with L-lysin is 3 month. Intervention 2: In control group : placebo is powder as the same shape and color as L-lysine in combination with chemotherapy drugs ,twice a day foe 3 month.;Treatment - Drugs;Treatment - Drugs;L-Lisyne powder 1.5g twice per day in combination with drugs of chemical therapy for patients in treatment group.
The duration of treatment with L-lysin is 3 month.;In control group : placebo is powder as the same shape and color as L-lysine in combination with chemotherapy drugs ,twice a day foe 3 month.
Primary outcome(s): ERCC1(Excision repair cross-complementing rodent repair deficiency, complementation group 1). Timepoint: Baseline and 3 monhts following the end of treatment. Method of measurement: ELISA kit.;VEGF(Vascular endothelial growth facto). Timepoint: Baseline and 3 monhts following the end of treatment. Method of measurement: ELISA kit.;DPD(Dihydropyrimidine dehydrogenase deficiency. Timepoint: Baseline and 3 monhts following the end of treatment. Method of measurement: ELISA kit.;TS(Thymidylate synthase). Timepoint: Baseline and 3 monhts following the end of treatment. Method of measurement: ELISA kit.;CEA-Carcino Embryonic Antigen. Timepoint: Baseline and 3 monhts following the end of treatment. Method of measurement: ELISA kit.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention.
| 2480091 | ecrin-mdr-crc
Project description:Intervention 1: group two take a combination of probiotic and honey (two probiotic capsules and 30 grams honey per day, one capsule and 15 grams honey in the morning after breakfast and another one capsule in the evening, and 15 grams honey at night). Intervention 2: group three are the control group receive two placebo capsules (containing 500 mg of corn starch) per day, one capsule in the morning after breakfast and another one in the evening. Intervention 3: group one take probiotics )contained: Lactobacillus casei 1.5 × 109 CFU, Lactobacillus acidophilus 1.5 × 1010 CFU, Lactobacillus rhamnosus 3.5 × 109 CFU, Lactobacillus bulgaricus 2.5 × 108 CFU, Bifidobacterium breve 1 × 1010 CFU, Bifidobacterium longum 5 × 108 CFU and Streptococcus thermophilus 1.5 × 108 CFU per 500 mg(; two probiotic capsules per day, one capsule in the morning after breakfast and another one in the evening.;Treatment - Drugs;Treatment - Drugs;Treatment - Drugs;group two take a combination of probiotic and honey (two probiotic capsules and 30 grams honey per day, one capsule and 15 grams honey in the morning after breakfast and another one capsule in the evening, and 15 grams honey at night);group three are the control group receive two placebo capsules (containing 500 mg of corn starch) per day, one capsule in the morning after breakfast and another one in the evening;group one take probiotics )contained: Lactobacillus casei 1.5 × 109 CFU, Lactobacillus acidophilus 1.5 × 1010 CFU, Lactobacillus rhamnosus 3.5 × 109 CFU, Lactobacillus bulgaricus 2.5 × 108 CFU, Bifidobacterium breve 1 × 1010 CFU, Bifidobacterium longum 5 × 108 CFU and Streptococcus thermophilus 1.5 × 108 CFU per 500 mg(; two probiotic capsules per day, one capsule in the morning after breakfast and another one in the evening
Primary outcome(s): Diarrhea grade. Timepoint: Weekly from one week before radiotherapy until end of treatment. Method of measurement: Common Toxicity Criteria system.;Stool consistency score. Timepoint: Weekly from one week before radiotherapy until end of treatment. Method of measurement: Bristol scales.;Blood cell counts. Timepoint: Weekly from one week before radiotherapy until end of treatment. Method of measurement: cell counter machine.;Serum IgA level. Timepoint: Weekly from one week before radiotherapy until end of treatment. Method of measurement: Autoanalyzer machine.
Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
| 2485704 | ecrin-mdr-crc
Project description:Intervention 1: intervention:
6 mg melatonin every night for 30 days. Intervention 2: control:
10 mg zolpidem at night for 30 days.;Treatment - Drugs;Treatment - Drugs;intervention:
6 mg melatonin every night for 30 days;control:
10 mg zolpidem at night for 30 days
Primary outcome(s): Sleep quality. Timepoint: At baseline, 1 month after the baseline and 2 months after baseline. Method of measurement: Pittsburgh Questionnaire.;Sleep quality. Timepoint: At baseline, 2 weeks and 1 month after the baseline and 2 months after baseline. Method of measurement: GSQS Questionnaire.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.
| 2488847 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: Nanocurcumin 40 mg capsule formulated by Exir Nanosina Inc. thrice a day (after breakfast, lunch and dinner) for 6 21-day courses of XELOX or FOLFOX regimen. Intervention 2: Control group: Placebo with the same appearance prepared by Exir nano Sina Inc. thrice a day (after breakfast, lunch and dinner) for 6 21-day courses of XELOX or FOLFOX regimen.
Primary outcome(s): Metastatic extent. Timepoint: after three courses of chemotherapy and the end of six courses. Method of measurement: Periodic Radiography.;Assess CRP levels. Timepoint: At the beginning and after the end of three and six chemotherapy courses. Method of measurement: Blood test.;Assess CEA and CA19-9 levels. Timepoint: At the end of three courses and six courses of chemotherapy. Method of measurement: Blood test.;Radiographic response of the tumor. Timepoint: after three courses of chemotherapy and the end of six courses. Method of measurement: (RECIST1.1), based on the doctor’s clinical examination.
Study Design: Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization using Randomization.com will implemented. This method uses simple randomization models such as head or tail, using a random number table or using computer randomization methods, and for example, each client by dropping coin will include in control or intervention group. This method is very simple to implement. Patients will receive enrollment number 1 or 2, respectively, and enter one of two groups of drugs or placebo, Blinding description: Nano-curcumin and placebo soft gels packages in identical bottle will be delivered to the clinician. Patients who meet the inclusion criteria will be selected by clinician to be included in the study, randomly assigned to a drug or placebo group and be given a bottle with A or B mark. The physician and the resident of clinical pharmacy will evaluate patients in the course of treatment. Dat
| 2501499 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: bowel preparation with polyethilenglycol and bisacodyl tablet since 24 hours befor trearment and also rifaximin 400 mg BD since 7 days befor treatment. Intervention 2: Control group: bowel preparation with polyethilenglycol and bisacodyl tablet since 24 hours befor trearment.
Primary outcome(s): Rectal volume. Timepoint: Before(basement) and 7 days after oral Rifaximin. Method of measurement: HDR plus 3.0.8 brachytherapy , treatment planning, Bebig & Ziegler company.;Rectal Dose-volume parameters. Timepoint: Before(basement) and 7 days after oral Rifaximin. Method of measurement: HDR plus 3.0.8 brachytherapy treatment planning, Bebig & Ziegler company.
Study Design: Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.
| 2501076 | ecrin-mdr-crc
Project description:Intervention 1: The intervention is implementing the critical path, that all patient interventions, including tests, diet, patient education is defined in specific line time. At the end of intervention patient satisfaction measured by satisfaction questionair, length of stay and complication of surgery record from patient file. Intervention 2: All interventions in control group performed with routin hospital.;Treatment - Drugs;The intervention is implementing the critical path, that all patient interventions, including tests, diet, patient education is defined in specific line time. At the end of intervention patient satisfaction measured by satisfaction questionair, length of stay and complication of surgery record from patient file.;All interventions in control group performed with routin hospital.
Primary outcome(s): Patient satisfaction. Timepoint: The end of intervention. Method of measurement: Satisfaction questionair.;Complications after surgery. Timepoint: During the intervention. Method of measurement: Recorded from patient file.;Length of stay. Timepoint: End of intervention. Method of measurement: Record from patient file.
Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.
| 2481410 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: Nanosiline Marine 70 mg capsule (softgel sinalive 70mg) prepared by Elixir Nanosina Company twice a day (after breakfast and dinner) for 6 21-day courses of XELOX or FOLFOX diet. Intervention 2: Control group: Placebo with the same appearance prepared by Exiranano Sina Company twice a day (after breakfast and dinner) for 6 21-day courses of XELOX or FOLFOX diet.
Primary outcome(s): Assess CRP levels. Timepoint: At the beginning and after the end of three and six chemotherapy courses. Method of measurement: Blood test.;Assess CEA and CA19-9 levels. Timepoint: At the end of three courses and six courses of chemotherapy. Method of measurement: Blood test.;Radiographic response of the tumor. Timepoint: Then three courses of chemotherapy and the end of six courses. Method of measurement: (RECIST1.1), based on the doctor’s clinical examination.;Metastatic extent. Timepoint: Then three courses of chemotherapy and the end of six courses. Method of measurement: Periodic Radiography.
Study Design: Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: With the help of a randomization list provided by randomization.com site, patients in the order of inclusion in the study will receive code 1 or 2 and will be included in placebo or medication group, Blinding description: Nano-silymarin and placebo soft gels packages in identical-looking bottle will be delivered to the clinician. Patients who meet the inclusion criteria will be selected by clinician to be included in the study, randomly assigned to a drug or placebo group and be given a bottle with A or B mark. The physician and the resident of clinical pharmacy will evaluate patients in the course of treatment. Data collection and analysis will be performed by the clinical pharmacy resident and the clinical pharmacist. All of them will be unaware that A or B is on medication or placebo until the end of the study and data analysis.
| 2501497 | ecrin-mdr-crc
Project description:Intervention 1: Daily supplementation of one 100 mg capsule with food (starting from a week before chemotherapy until the end of second chemotherapy cycle ( a total of 7 weeks). Intervention 2: Daily supplementation of one placebo capsule with food (starting form a week before chemotherapy until the end of second chemotherapy cycle ( a total of 7 weeks).;Placebo;Daily supplementation of one 100 mg capsule with food (starting from a week before chemotherapy until the end of second chemotherapy cycle ( a total of 7 weeks);Daily supplementation of one placebo capsule with food (starting form a week before chemotherapy until the end of second chemotherapy cycle ( a total of 7 weeks)
Primary outcome(s): Serum levels of Matrix Metalloproteinase-7 , 9 (MMP-7,9). Timepoint: Before and after the intervention (7 weeks). Method of measurement: ElISA.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.
| 2487787 | ecrin-mdr-crc
Project description: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.
| 2479569 | ecrin-mdr-crc
Project description:Intervention 1: Control group: Placebo was given every 12 hours/ orally from 4 days before through 10 days after operation. Intervention 2: Case group: Balance capsule made in England was given every 12 hours/ orally from 4 days before through 10 days after operation.;Treatment - Drugs;Treatment - Drugs;Control group: Placebo was given every 12 hours/ orally from 4 days before through 10 days after operation;Case group: Balance capsule made in England was given every 12 hours/ orally from 4 days before through 10 days after operation
Primary outcome(s): Surgical site infection. Timepoint: beginning of intervention and first, second, third, tenth and thirtieth days after operation. Method of measurement: fever, respiratory rate, pulse rate, pulse rate, cellulitis, dyscharge.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Giving the medicine to the patients was arranged in a double blind method so as to guarantee the minimum of the physician´s personal prejudgment when filling the patients’ form and the maximum of the patient´s cooperation. Neither the physician nor the patients had any knowledge about the type of medicine.
| 2480678 | ecrin-mdr-crc