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Evaluation of the effect of black seed (Nigella sativa) on symptom severity in food-induced Irritable Bowel Syndrome.

Protocol summary

Study aim
the aim of this study was to evaluate the effect of nigella sativa on symptom severity in patients with food- induced irritable bowel syndrome IBS and to assess whether the improvement in IBS symptoms was maintained after discontinuation of the intervention.
Design
A prospective, single-arm interventional trial
Settings and conduct
Conducted at outpatient gastroenterology/internal medicine clinics in Mosul, Iraq on food-triggered IBS patients. After baseline assessment, patients took daily raw Nigella sativa seeds for 2 weeks, followed by a 2-week post-treatment evaluation. Open-label, unblinded, non-placebo-controlled study.
Participants/Inclusion and exclusion criteria
Patients between the ages of 18 and 52 who met the Rome IV diagnostic criteria for IBS and reported recurrent gastrointestinal symptoms that were commonly brought on by or made worse by specific meals were assessed for eligibility. The following were the exclusion criteria: Inflammatory bowel disease, coeliac disease, and gastrointestinal cancer are examples of organic gastrointestinal illnesses. severe long-term systemic problems (such uncontrolled cardiovascular disease, hepatic dysfunction, or renal failure). Sensitivities or allergy to Nigella sativa. lactation or pregnancy. Use of additional probiotics, herbal remedies, or typical IBS medicines (such as laxatives, antispasmodics, or antidiarrheals) within two weeks previous to baseline.
Intervention groups
Each participant received a pre-weighed box containing 30 g of raw, whole Nigella sativa seeds; this corresponds to a daily chewing of 2 g for 15 consecutive days.
Main outcome variables
The primary outcome variable is the change in the severity of gastrointestinal symptoms related to food-induced IBS (such as abdominal pain, bloating, and bowel habit changes)

General information

Reason for update
Acronym
NS - IBS
IRCT registration information
IRCT registration number: IRCT20260806070557N1
Registration date: 2026-08-29, 1405/06/07
Registration timing: retrospective

Last update: 2026-08-29, 1405/06/07
Update count: 0
Registration date
2026-08-29, 1405/06/07
Registrant information
Name
Zahraa Younus
Name of organization / entity
The University of Al-Hamdaniya
Country
Iraq
Phone
+964 770 516 2692
Email address
pharmacistzahra89@uohamdaniya.edu.iq
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-04-01, 1405/01/12
Expected recruitment end date
2026-09-01, 1405/06/10
Actual recruitment start date
2026-04-01, 1405/01/12
Actual recruitment end date
2026-07-01, 1405/04/10
Trial completion date
2026-07-01, 1405/04/10
Scientific title
Evaluation of the effect of black seed (Nigella sativa) on symptom severity in food-induced Irritable Bowel Syndrome.
Public title
Effect of black seed (Nigella sativa) on symptom severity in food-induced Irritable Bowel Syndrome.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Adult aged 18 - 52 years All with food- induced irritable bowel syndrome who met the study eligibility criteria And agreed to participate in this study.
Exclusion criteria:
Inflammatory bowel disease coeliac disease, gastrointestinal cancer are examples of organic gastrointestinal illnesses severe long-term systemic problems (such uncontrolled cardiovascular disease, hepatic dysfunction, or renal failure). Sensitivities or allergy to Nigella sativa. lactation or pregnancy
Age
From 18 years old to 52 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
not applicable

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
University of Al- Hamdaniya - research ethics committee
Street address
Mosul - Bartella
City
Mosul - Bartella
Postal code
41001
Approval date
2026-03-29, 1405/01/09
Ethics committee reference number
UH.2026.003

Health conditions studied

1

Description of health condition studied
Food - induced irritable bowel syndrome
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome

Primary outcomes

1

Description
Change in Irritable Bowel Syndrome (IBS) symptom severity score, including abdominal pain, bloating, and bowel habit frequency.
Timepoint
Measured at baseline (day 0), at the end of the 2-week active intervention period, and at the end of the 2-week post-intervention follow-up phase.
Method of measurement
Evaluated using a standardized IBS symptom severity questionnaire and self-reported patient symptom score logs.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: intervention group: Each participant received a pre-weighed box containing 30 g of raw, whole Nigella sativa seeds (2 g daily for 15 days). Participants were instructed to chew the seeds thoroughly (0.67 g per meal) after main meals and swallow them with water.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Private Outpatient Gastroenterology and Internal Medicine Clinics
Full name of responsible person
Zahraa Younus Saeed
Street address
Mosul - Bartella
City
Mosul - Bartella
Postal code
41001
Phone
+964 770 516 2692
Email
zahraays1989@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
self funding
Full name of responsible person
Zahraa Younus
Street address
Mosul - Bartella
City
Mosul - Bartella
Postal code
41001
Phone
+964 770 516 2692
Email
zahraays1989@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
self funding
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Foreign
Category of foreign source of funding
Sponsor: country of origin
Country of origin
IQ
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Al-Hamdaniya
Full name of responsible person
Zahraa Younus Saeed
Position
assistant lecturer
Latest degree
Master
Other areas of specialty/work
Medical Pharmacy
Street address
Mosul - Bartella
City
Mosul - Bartella
Province
Nineveh
Postal code
41001
Phone
+964 770 516 2692
Email
zahraays1989@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Al-Hamdaniya
Full name of responsible person
Zahraa Younus Saeed
Position
Assistant lecturer
Latest degree
Master
Other areas of specialty/work
Medical Pharmacy
Street address
Mosul - Bartella
City
Mosul - Bartella
Province
Nineveh
Postal code
41001
Phone
+964 770 516 2692
Email
zahraays1989@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Al-Hamdaniya
Full name of responsible person
Zahraa Younus Saeed
Position
assistant lecturer
Latest degree
Master
Other areas of specialty/work
Medical Pharmacy
Street address
Mosul - Bartella
City
Mosul - Bartella
Province
Nineveh
Postal code
41001
Phone
+964 770 516 2692
Email
zahraays1989@gmail.com

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
Undecided - It is not yet known if there will be 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
All collected de-identified individual participant data, study protocol, statistical analysis plan, and informed consent form.
When the data will become available and for how long
Data will become available immediately upon publication of the study results and will remain available for 5 years.
To whom data/document is available
Qualified researchers and academicians upon reasonable request.
Under which criteria data/document could be used
For scientific research, meta-analysis, and validation of study findings only.
From where data/document is obtainable
Directly from the principal investigator via email.
What processes are involved for a request to access data/document
email to the principal investigator along with a brief research proposal. Responses will be provided within 2-4 weeks.
Comments
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