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The Effect of Piloshot Capsule on Symptoms and Emotional Status in Patients with Chronic Fatigue Syndrome: A Randomized Double-Blind Clinical Trial

The Effect of Piloshot Capsule on Symptom Severity and Emotional Status in Patients with Chronic Fatigue Syndrome: A Randomized Double-Blind Placebo-Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250802066731N1
Enrollment
50
Registered
2025-08-09
Start date
2025-08-31
Completion date
Unknown
Last updated
2025-08-19

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

Conditions

Chronic Fatigue Syndrome.

Interventions

Intervention 1: Treatment Group : Receives: 2 Piloshot capsules (500 mg each, produced by BSK Pharmaceutical Company) daily Dosage: 1 capsule in morning + 1 capsule in evening Durati

Sponsors

Zahedan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Definitive diagnosis of Chronic Fatigue Syndrome based on the Chronic Fatigue Syndrome Questionnaire Age above 18 years and below 65 years

Exclusion criteria

Exclusion criteria: Active medical conditions that could explain chronic fatigue (e.g., untreated hypothyroidism, sleep apnea, narcolepsy, drug side effects) Unresolved prior medical diagnoses (e.g., chronic hepatitis, malignancies) Current or history of psychiatric disorders (e.g., major depressive disorder with psychotic/melancholic features, bipolar disorder, schizophrenia, anxiety disorders, dementia, eating disorders) Use of medications that may interfere with study results or cannot be safely discontinued Pregnancy or lactation Non-compliance with study follow-up Tobacco use, alcohol consumption, or substance abuse

Design outcomes

Primary

MeasureTime frame
Severity of chronic fatigue syndrome symptoms. Timepoint: Baseline (pre-intervention) - Week 4 post-treatment - Week 8 post-treatment - Week 12 post-treatment. Method of measurement: Standardized fatigue severity questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Vahidi

Zahedan University of Medical Sciences

a.vahidi@zaums.ac.ir+98 54 3351 3778

Outcome results

None listed

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