The effect of Spinal-z in gastric adenocarcinoma

Efficacy of Spinal-Z compared with placebo in metastatic gastric adenocarcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2013010111967N1

Enrollment

Registered

2013-03-03

Start date

2012-11-21

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Gastric adenocarcinoma. Neoplasm of stomach. cardia. body. pyloric. lesser curvature of stomach. Greater curvature of stomach

Interventions

Intervention 1: 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 c

Treatment - Drugs

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 bot

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.

Eligibility

Sex/Gender

All

Age

15 Years to 65 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Dysphagia. Timepoint: Every 3 weeks until 3 months. Method of measurement: Questionnaire.;Abdominal pain. Timepoint: Every 3 weeks until 3 months. Method of measurement: Questionnaire.;Anorexia. Timepoint: Every 3 weeks until 3 months. Method of measurement: Questionnaire.;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).;Fasting blood sugar. Timepoint: Every 3 weeks until 3 months. Method of measurement: Laboratory kit of blood sugar.;Blood pressure. Timepoint: Every 3 weeks until 3 months. Method of measurement: Mercury Sphyngomanometer.;Hemoglobin. Timepoint: Every 3 weeks until 3 months. Method of measurement: Hemoglobinometer( with cyanmethemoglobin).;Liver enzymes. Timepoint: Every 6 weeks until 3 months. Method of measurement: Laboratory kit of liver enzymes.;Erythrocyte sedimentation rate(ESR). Timepoint: Every 6 weeks until 3 months. Method of measurement: Westergren( laboratory method).;Platelets. Timepoint: Every 3 weeks until 3 months. Method of measurement: Electronics impedance( laboratory method).;White blood cells. Timepoint: Every 3 weeks until 3 months. Method of measurement: Electronics impedance( laboratory method).	—

Measure

Time frame

Dysphagia. Timepoint: Every 3 weeks until 3 months. Method of measurement: Questionnaire.;Abdominal pain. Timepoint: Every 3 weeks until 3 months. Method of measurement: Questionnaire.;Anorexia. Timepoint: Every 3 weeks until 3 months. Method of measurement: Questionnaire.;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).;Fasting blood sugar. Timepoint: Every 3 weeks until 3 months. Method of measurement: Laboratory kit of blood sugar.;Blood pressure. Timepoint: Every 3 weeks until 3 months. Method of measurement: Mercury Sphyngomanometer.;Hemoglobin. Timepoint: Every 3 weeks until 3 months. Method of measurement: Hemoglobinometer( with cyanmethemoglobin).;Liver enzymes. Timepoint: Every 6 weeks until 3 months. Method of measurement: Laboratory kit of liver enzymes.;Erythrocyte sedimentation rate(ESR). Timepoint: Every 6 weeks until 3 months. Method of measurement: Westergren( laboratory method).;Platelets. Timepoint: Every 3 weeks until 3 months. Method of measurement: Electronics impedance( laboratory method).;White blood cells. Timepoint: Every 3 weeks until 3 months. Method of measurement: Electronics impedance( laboratory method).

—

Secondary

Measure	Time frame
Vomiting. Timepoint: Every 3 weeks until 3 months. Method of measurement: Questionnaire.;Itching. Timepoint: Every 3 weeks until 3 months. Method of measurement: Questionnaire.;Nausea. Timepoint: Every 3 weeks until 3 months. Method of measurement: Questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactEhsanpour. Ali, MD

Ahvaz Jundishapur University of Medical Sciences

ali990ehs@yahoo.com+98 61 1374 3013

Outcome results

None listed

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