An herbal medication as complementary conventional chemotherapy for gastric and esophageal cancer patients

Evaluation of the efficacy of Spinal-Z with conventional chemotherapy on the survival of gastric and esophageal cancer patients: A randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016092529963N1

Enrollment

Registered

2016-12-21

Start date

2008-04-01

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

Condition 1: Oesophagus cancer. Condition 2: Gastric cancer. Malignant neoplasm of oesophagus Malignant neoplasm of stomach

Interventions

Intervention 1: Intervention group: patients was treated with conventional chemotherapy plus Spinal-Z. Patients received 500 or 700 mg Spinal-Z oral capsules, 2 or 3 times a day. The spinal-Z capsule

Treatment - Drugs

Intervention group: patients was treated with conventional chemotherapy plus Spinal-Z. Patients received 500 or 700 mg Spinal-Z oral capsules, 2 or 3 times a day. The spinal-Z capsule was manufactured

Control group: Patients received conventional chemotherapy plus placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion criteria: Histologically confirmed esophageal squamous cell carcinoma or Adenocarcinoma of the distal esophagus or gastric cancer; The Largest diameter of the lesion = 10 mm based on Spiral-CT Scan; The absence of brain metastases; Karnofsky Performance status scale =70%; Age>=18 Exclusion criteria: Congestive heart failure (EF 5 folds the normal limits; Bilirubin serum = 5 mg per deciliter; serum Creatinine level > 2 milligrams per deciliter); WBC < 2500 per cubic millimeter of blood; Platelet count < 100,000 per cubic millimeter of blood ; Pregnant and nursing mothers; Any type of active infection ; IV drug users ; Major psychological disorders

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Overall survival. Timepoint: 30 months. Method of measurement: Patients were visited in 0, 8 and 24 weeks after the beginning of intervention, and their health status was evaluated. Patients then were followed up via telephone contacts and cancer registry data.	—

Secondary

Measure	Time frame
-. Timepoint: -. Method of measurement: -.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAsieh Shahrabi Farahani

Digestive Diseases Research Institute

asieh.farahani@yahoo.com+98 21 8241 5192

Outcome results

None listed

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