Protocol summary

Summary
This study is a single blind, clinical trial that evaluates the effects of Spinal-z on patients with metastatic gastric adenocarcinoma. The Patients who enter this study are between 15 and 65 years old and they have received pathologic diagnosis of gastric adenocarcinoma (stage 4). The Patients with creatinine over than 2 or Ejection Fraction less than 45%, are excluded from the study. About 78 patients are evaluated in this study. The patients are divided randomly interventional and control. The patients do not know about 2 group interventional and control (single blind). The patients in interventional group are treated by 6 Spinal-z capsules daily (2 capsules after breakfast, 2 capsules after lunch and 2 capsules after dinner). The control group is treated by 6 capsules of placebo in the same order. There is no difference between placebo and spinal-z capsules in shape, weight, color, taste and odor. The patients are visited and evaluated once every three weeks for 3 months. The patients are evaluated for digestive signs (dysphagia, abdominal pain and anorexia), itching, nausea, vomiting, Blood urea nitrogen, creatinine, fasting blood sugar, blood pressure, heart rate, hemoglobin, platelets, white blood cells, and their liver enzymes are evaluated every 6 weeks. Digestive signs scale from 0 to 10 score and according to this scaling, patients are divided to, mild (1-3), moderate (4-6), severe (7-10) and zero (0). The patients are excluded from the study in case of exposure to severe complications, or disagreement to carry on the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013010111967N1
Registration date: 2013-03-03, 1391/12/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-03-03, 1391/12/13
Registrant information
Name
Alireza Ghanbaran
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1337 7065
Email address
ghanbaran.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz JundiShapur University of Medical Sciences
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2013-01-20, 1391/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Spinal-Z compared with placebo in metastatic gastric adenocarcinoma
Public title
The effect of Spinal-z in gastric adenocarcinoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The Patients who enter this study are between 15 and 65 years old and they have received pathologic diagnosis of gastric adenocarcinoma (stage 4) Exclusion criteria: Patients with creatinine over than 2 and Ejection Fraction less than 45% and exposure to severe complications.
Age
From 15 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 78
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee, Ahvaz Jundishapur University of Medical Sciences
Street address
Ethics Committee, Ahvaz Jundishapur University of Medical Sciences, Golestan Street, Ahvaz
City
Ahvaz
Postal code
61357-15794
Approval date
2012-10-27, 1391/08/06
Ethics committee reference number
ETH-639

Health conditions studied

1

Description of health condition studied
Gastric adenocarcinoma
ICD-10 code
c16,c16-1,
ICD-10 code description
Neoplasm of stomach. cardia. body. pyloric. lesser curvature of stomach. Greater curvature of stomach

Primary outcomes

1

Description
Dysphagia
Timepoint
Every 3 weeks until 3 months
Method of measurement
Questionnaire

2

Description
Abdominal pain
Timepoint
Every 3 weeks until 3 months
Method of measurement
Questionnaire

3

Description
Anorexia
Timepoint
Every 3 weeks until 3 months
Method of measurement
Questionnaire

4

Description
Glomerular filtration rate(GFR)
Timepoint
Every 3 weeks until 3 months
Method of measurement
Cockcroft-Gault: CrCl (mL/min) = (140 – age (years) x weight (kg) x [0.85 if female])/(72 x sCr (mg/dL)

5

Description
Fasting blood sugar
Timepoint
Every 3 weeks until 3 months
Method of measurement
Laboratory kit of blood sugar

6

Description
Blood pressure
Timepoint
Every 3 weeks until 3 months
Method of measurement
Mercury Sphyngomanometer

7

Description
Hemoglobin
Timepoint
Every 3 weeks until 3 months
Method of measurement
Hemoglobinometer( with cyanmethemoglobin)

8

Description
Liver enzymes
Timepoint
Every 6 weeks until 3 months
Method of measurement
Laboratory kit of liver enzymes

9

Description
Erythrocyte sedimentation rate(ESR)
Timepoint
Every 6 weeks until 3 months
Method of measurement
Westergren( laboratory method)

10

Description
Platelets
Timepoint
Every 3 weeks until 3 months
Method of measurement
Electronics impedance( laboratory method)

11

Description
White blood cells
Timepoint
Every 3 weeks until 3 months
Method of measurement
Electronics impedance( laboratory method)

Secondary outcomes

1

Description
Vomiting
Timepoint
Every 3 weeks until 3 months
Method of measurement
Questionnaire

2

Description
Itching
Timepoint
Every 3 weeks until 3 months
Method of measurement
Questionnaire

3

Description
Nausea
Timepoint
Every 3 weeks until 3 months
Method of measurement
Questionnaire

Intervention groups

1

Description
The patients in interventional group are treated by 6 Spinal-z capsules daily (2 capsules after breakfast, 2 capsules after lunch and 2 capsules after dinner) for 3 months. Spinal-z capsules is a botanical medicine. Each capsule contains the essence of the Peganum Harmala Linn. Its most effective substance is B- carboline alkaloids, which can control and restrain the duplication of malignant cells, and is produced by Daroupakhsh MFG company.
Category
Treatment - Drugs

2

Description
The patients in control group are treated by 6 placebo Capsules daily(2 capsules after breakfast, 2 capsules after lunch and 2 capsules after dinner) for 3 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Ehsanpour. Ali, MD
Street address
Shafa Hospital, Golestan Street, Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz JundiShapur University of Medical Sciences
Full name of responsible person
Feghei, MD
Street address
Vice chancellor for research, Ahvaz JundiShapur University of Medical Sciences, Golestan Street, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz JundiShapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Ehsanpour. Ali, MD
Position
Internist
Other areas of specialty/work
Street address
Shafa Hospital, Golestan Street, Ahvaz
City
Ahvaz
Postal code
61357-33119
Phone
+98 61 1374 3013
Fax
+98 61 1374 3013
Email
ali990ehs@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hoseinzadeh. Mehran, MD
Position
Hematologist
Other areas of specialty/work
Street address
Shafa Hospital, Golestan Street, Ahvaz
City
Ahvaz
Postal code
61357-33119
Phone
+98 61 1374 3013
Fax
Email
hoseinzadehmehran@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Zalaki. shahlla
Position
Other areas of specialty/work
Street address
Golestan Hospital, Golestan Street, Ahvaz
City
Ahvaz
Postal code
61357-33119
Phone
+98 61 1374 3013
Fax
+98 61 1374 3013
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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