Effects of “compound Ma-ol-asal" syrup on cancer-related fatigue

Effects of “compound Ma-ol-asal" syrup on cancer-related fatigue in gastrointestinal (GI) cancer patients who are undergoing chemotherapy

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191211045693N1

Enrollment

120

Registered

2022-08-20

Start date

2022-07-23

Completion date

Unknown

Last updated

2022-08-29

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

Conditions

Neoplastic (malignant) related fatigue. Neoplastic (malignant) related fatigue

Interventions

Intervention 1: Intervention group:In addition to all the standard and required medicines, patients with GI cancer-related fatigue receiving “compound Ma-ol-asal" syrup that is made by Niak Pharmaceut

. Intervention 2: Control group: In addition to all the standard and required medicines, patients with GI cancer-related fatigue receiving placebo that is made by Niak pharmaceutical company , 10 cc

Eligibility

Sex/Gender

All

Age

18 Years to 78 Years

Inclusion criteria

Inclusion criteria: 1.Age between 18- 70 years old 2. GI cancer (pathologically diagnosed) 3.Undergoing chemotherapy 4. Hemoglobin level at least 10g/dl 5. Hematocrit level at least 30% . 6. No clinical symptom of hypothyroidism 7. Visual Analogue Fatigue Scale (VAS)>=4

Exclusion criteria

Exclusion criteria: 1. Heart disease with unstable conditions 2. Liver disease with unstable conditions 3. Disabling pulmonary disease 4. Positive history of hypersensitivity to honey and its compounds 5. Positive history of hypersensitivity to each component of the “compound Ma-ol-asal" syrup. 6. Uncontrolled pain. 7. An individual who uses treatment due to known psychiatric disease 8.Pregnancy. 9. Simultaneous use of drugs that affect fatigue. 10. kidney disease with unstable conditions 11. Severe infection 12. Serious accompanying disease.

Design outcomes

Primary

Measure	Time frame
Score of Fatigue Severity "Visual Analogue Fatigue Scale". Timepoint: Week 0 (before the start of the intervention) and week 4 (after the start of the intervention). Method of measurement: Using Visual Analogue Fatigue Scale questionnaire.;Score of "The Cancer Fatigue Scale". Timepoint: The weeks of 0 and 4 after treatment. Method of measurement: The Cancer Fatigue Scale questionnaire.	—

Secondary

Measure	Time frame
Dyspepsia. Timepoint: Week 0 (before the start of the intervention) and week 4 (after the start of the intervention). Method of measurement: Likert scale.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAta Amani

Shahid Beheshti University of Medical Sciences

dr-amani@sbmu.ac.ir+98 21 8877 3521

Outcome results

None listed

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