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IRCT20250802066731N1 IRCT 2025-08-09 Zahedan University of Medical Sciences The Effect of Piloshot Capsule on Symptoms and Emotional Status in Patients with Chronic Fatigue Syndrome: A Randomized Double-Blind Clinical Trial PSC 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 2025-08-31 anticipated 50 Complete https://irct.ir/trial/85335 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: n this study, the random sequence will be generated using R software version 4.2.2 with block randomization (block sizes of 4 and 6). Participants will be randomly allocated using sequentially numbered sealed envelopes to either the intervention group (receiving Piloshot capsule) or control group (receiving placebo). Outcome assessments will be conducted in a double-blind manner by both researchers and participants, with allocation codes maintained by an independent statistics unit.", Blinding description: In this study, both participants and assessing researchers will remain unaware of the assigned treatment (Piloshot or placebo).The intervention and placebo capsules will be designed to be identical in appearance, color, odor, and packaging.allocation information will be accessible only to the independent statistician who will not participate in treatment or evaluation procedures.Allocation codes will remain concealed until completion of final data analysis. 3 Chronic Fatigue Syndrome. 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 Duration: 8 weeks of continuous treatment . Intervention 2: Control group: Receives: Placebo (manufactured by Mashhad University of Medical Sciences School of Pharmacy) Matching: Identical in shape, color, and packaging to active drug Schedule: Same dosing regimen as treatment groupStudy Procedures Randomization & Blinding:Treatment assignment by independent head nurse Secure coding system implementation Double-blind maintenance (participants & investigators). Yes - There is a plan to make this available What will be shared: Participants will be coded to facilitate data access and management; however, only primary outcomes will be published, and no individual participant data will be disclosed under any circumstances." When: 6 months after publication of the results To whom: General Use Conditions: Here are professional ways to reference ethical compliance in your manuscript: Where to obtain: Electronic mail How to obtain: The requester must first send an email message explaining the purpose of data usage. Within one week, the information will be sent to the applicant with applicable terms and restrictions. Comments:
public Ali Vahidi
Baharan Psychiatric Teaching Hospital, Imam Khomeini Ave., Across from Grain Storage Facility
Zahedan Iran (Islamic Republic of) 9819713955 +98 54 3351 3778 a.vahidi@zaums.ac.ir Zahedan University of Medical Sciences scientific Ali Vahidi
Baharan Medical Center, Imam Khomeini Ave., Across from Grain Storage Facility
Zahedan Iran (Islamic Republic of) 9819713955 +98 54 3351 3778 a.vahidi@zaums.ac.ir Zahedan University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of Chronic Fatigue Syndrome based on the Chronic Fatigue Syndrome Questionnaire Age above 18 years and below 65 years 18 years 65 years Both 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 Treatment - Drugs Placebo Treatment Group : Receives: 2 Piloshot capsules (500 mg each, produced by BSK Pharmaceutical Company) daily Dosage: 1 capsule in morning + 1 capsule in evening Duration: 8 weeks of continuous treatment . Control group: Receives: Placebo (manufactured by Mashhad University of Medical Sciences School of Pharmacy) Matching: Identical in shape, color, and packaging to active drug Schedule: Same dosing regimen as treatment groupStudy Procedures Randomization & Blinding:Treatment assignment by independent head nurse Secure coding system implementation Double-blind maintenance (participants & investigators) 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. Zahedan University of Medical Sciences Approved 2025-07-18 Ethics Committee of Zahedan University of Medical Sciences Medical Sciences Campus, Zahedan University of Medical Sciences, "Professor Habibollah Hosseini Square Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)