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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

Protocol summary

Study aim
To evaluate the effect of Piloshot capsule on symptom improvement and emotional status in patients with chronic fatigue syndrome
Design
This is a randomized, double-blind, parallel-group, controlled, phase 3 clinical trial conducted on 50 patients. For randomization in this study, the allocation sequence will be generated using R software (version 4.2.2) with block randomization (block sizes of 4 and 6).
Settings and conduct
This randomized double-blind placebo-controlled clinical trial enrolls 50 patients randomly allocated into two 25-subject groups. Medication allocation is coded by an independent head nurse.Assessments using DASS-21 questionnaire are conducted at baseline and weeks 4, 8, and 12, with data analyzed using SPSS version 30. Blinding of patients, physicians, and technicians is maintained using matched placebos and coding.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Confirmed diagnosis of Chronic Fatigue Syndrome based on international criteria,Age between 18-65 years,Willing and able to complete study questionnaires,Signed informed consent form Exclusion Criteria: Active medical conditions such as untreated hypothyroidism or severe sleep apnea, History of major psychiatric disorders (schizophrenia, bipolar disorder), Use of CNS-affecting medications, Pregnancy or lactation,History of substance abuse within past 6 months
Intervention groups
The intervention group will receive two 500 mg Piloshot capsules daily (morning and evening) for 8 weeks.The control group will receive an identical placebo in appearance, color, and packaging, following the same dosing schedule.All participants will receive standardized medication instructions.Treatment adherence will be monitored through:Pill count of remaining capsules. Daily patient self-reports of medication intake
Main outcome variables
Severity of chronic fatigue syndrome symptoms,DASS-21 questionnaire score

General information

Reason for update
Acronym
PSC
IRCT registration information
IRCT registration number: IRCT20250802066731N1
Registration date: 2025-08-09, 1404/05/18
Registration timing: prospective

Last update: 2025-08-09, 1404/05/18
Update count: 0
Registration date
2025-08-09, 1404/05/18
Registrant information
Name
Ali وحیدی
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5570
Email address
a.vahidi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-08-31, 1404/06/09
Expected recruitment end date
2026-03-18, 1404/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The Effect of Piloshot Capsule on Symptoms and Emotional Status in Patients with Chronic Fatigue Syndrome: A Randomized Double-Blind Clinical Trial
Purpose
Supportive
Inclusion/Exclusion 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:
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Medical Sciences Campus, Zahedan University of Medical Sciences, "Professor Habibollah Hosseini Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2025-07-18, 1404/04/27
Ethics committee reference number
IR.ZAUMS.REC.1404.154

Health conditions studied

1

Description of health condition studied
Chronic Fatigue Syndrome
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
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

Secondary outcomes

empty

Intervention groups

1

Description
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 .
Category
Treatment - Drugs

2

Description
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)
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Baharan Psychiatric Hospital
Full name of responsible person
Ali Vahidi
Street address
Baharan Psychiatric Teaching Hospital, Imam Khomeini Ave., Across from Grain Storage Facility
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9819713955
Phone
+98 54 3351 3778
Email
a.vahidi@zaums.ac.ir
Web page address
https://baharan.zaums.ac.ir/cantact

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Alireza Ansari Moghaddam
Street address
School of Medicine, Zahedan University of Medical Sciences, Persian Gulf Blvd., Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2116
Email
ansariaLireza@yahoo.com
Web page address
https://research.zaums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ali Vahidi
Position
Resident of Psychiatry
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Baharan Psychiatric Teaching Hospital, Imam Khomeini Ave., Across from Grain Storage Facility
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9819713955
Phone
+98 54 3351 3778
Email
a.vahidi@zaums.ac.ir
Web page address
https://baharan.zaums.ac.ir/cantact

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ali Vahidi
Position
"Resident of Psychiatry"
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Baharan Medical Center, Imam Khomeini Ave., Across from Grain Storage Facility
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9819713955
Phone
+98 54 3351 3778
Email
a.vahidi@zaums.ac.ir
Web page address
https://baharan.zaums.ac.ir/cantact

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ali Vahidi
Position
Resident of Psychiatry
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Baharan Psychiatric Hospital, Imam Khomeini Street, Opposite Wheat Silo
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9819713955
Phone
+98 54 3351 3778
Email
a.vahidi@zaums.ac.ir
Web page address
https://baharan.zaums.ac.ir/cantact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
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 the data will become available and for how long
6 months after publication of the results
To whom data/document is available
General Use
Under which criteria data/document could be used
Here are professional ways to reference ethical compliance in your manuscript:
From where data/document is obtainable
Electronic mail
What processes are involved for a request to access data/document
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.
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