Evaluation of the Effect of Ethanolic extract of Trachyspermum ammi as adjuvant in the reduction of bleeding in patients with IBD
Design
This clinical trial will be performed on 64 patients, divided into two groups of 32, including a control group and parallel groups. A simple double-blind, randomized study will be performed in this study.
Settings and conduct
The study is performed in the Liver and Digestive Clinic of Tohid Hospital in Sanandaj. The intervention group is given two 250 mg capsule of Ethanolic extract of Trachyspermum ammi daily for three months, along with standard treatment. The control group is given two placebo daily for three months with standard treatment.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age 18 to 75 years,Patients diagnosed with ulcerative colitis by a gastroenterologist Exclusion Criteria: Crohn's disease, Pregnancy, Breastfeeding, History of allergy to herbal medicines
Intervention groups
Intervention group: ethanolic extract of Trachyspermum ammi, oral capsule, 250 mg, twice a day for three months with standard treatment.
Control group: placebo containing starch, oral capsule, 250 mg, twice a day for three months with standard treatment.
Main outcome variables
number of bowel movements per day; the amount of daily bleeding from the rectum; classification of bleeding by a physician; OB; Hb; CRP; ESR
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190415043279N10
Registration date:2021-03-05, 1399/12/15
Registration timing:registered_while_recruiting
Last update:2021-03-05, 1399/12/15
Update count:0
Registration date
2021-03-05, 1399/12/15
Registrant information
Name
Pezhman Sharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3324 9435
Email address
p.sharifi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-10-23, 1400/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Ethanolic extract of Trachyspermum ammi as adjuvant in the reduction of bleeding in patients with IBD
Public title
Effect of Trachyspermum ammi in the reduction of bleeding in patients with IBD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 75 years
Patients diagnosed with Ulcerative colitis by a gastroenterologist
Exclusion criteria:
Crohn's disease
Pregnancy
Breastfeeding
History of allergy to herbal medicines
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
For apply randomization, the permuted block randomization will be used with quadruple blocks. Blocks will be produced by using the online site (www.sealedenvelope.com).
Using block randomization method and online statistical software (www.sealedenvelope.com), 64 patients will be divided into two equal groups of intervention and control in 8 blocks of 4. To hide random sequences, the sealed envelope method is used. First, a random sequence is created by one of the mentioned methods. then based on the sample size a number of envelopes with aluminum wrappers (in order to obscure the contents of the envelopes) are prepared and each of the random sequences created is recorded on a card. Finally, the lids of the envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, according to the order of entry of eligible participants into the study, one of the envelopes is opened in order and the assigned group of the participant is revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
All supplements and placebo capsules will be identical with respect to appearance and will differ only in the encoding of the capsules. The treatment code of the intervention supplements will be blind for subjects, investigators and staff involved in the conduct of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Pasdaran Blvd., Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
66117713446
Approval date
2020-09-08, 1399/06/18
Ethics committee reference number
IR.MUK.REC.1399.140
Health conditions studied
1
Description of health condition studied
Ulcerative colitis
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis
Primary outcomes
1
Description
Number of daily bowel movements
Timepoint
Beginning and end of the intervention
Method of measurement
Disease Activity Questionnaire
2
Description
Daily rectal bleeding
Timepoint
Beginning and end of the intervention
Method of measurement
Disease Activity Questionnaire
3
Description
Classification of bleeding according to symptoms and tests by a physician
Timepoint
Beginning and end of the intervention
Method of measurement
Disease Activity Questionnaire
4
Description
Fecal occult blood
Timepoint
Beginning and end of the intervention
Method of measurement
Stool test
5
Description
Blood Hemoglobin
Timepoint
Beginning and end of the intervention
Method of measurement
CBC test
6
Description
C-Reactive Protein
Timepoint
Beginning and end of the intervention
Method of measurement
Agglutination method
7
Description
Erythrocyte sedimentation rate (ESR)
Timepoint
Beginning and end of the intervention
Method of measurement
ESR device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Capsule containing Ethanolic extract of Trachyspermum ammi at two dose of 250 mg per day for three consecutive months. These oral capsules of Ethanolic extract of Trachyspermum ammi will be prepared by a reputable pharmacist.
Category
Placebo
2
Description
Control group: Placebo in capsules at two dose of 250 mg per day for three consecutive months. These placebo oral capsules contain starch and will be prepared by a reputable pharmacist.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Liver and Digestive Clinic of Tohid Hospital, Sanandaj
Full name of responsible person
Dr Farshad Sheikh esmaeili
Street address
Tohid Hospital, Tohid Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6616813131
Phone
+98 87 3328 6112
Email
dr_s_smaili@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr. Afshin Maleki
Street address
Vice Chancellor for research of Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran.
City
Sanandaj
Province
Kurdistan
Postal code
6617713466
Phone
+98 87 3366 4645
Email
maleki43@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Dr Farshad Sheikhesmaeili
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Liver and Digestive
Street address
Tohid Hospital, Tohid Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Email
dr_s_smaili@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr Farshad Sheikhesmaeili
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Liver and Digestive
Street address
Tohid Hospital, Tohid Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6616813131
Phone
+98 87 3328 6112
Email
dr_s_smaili@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Pezhman Sharifi
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Microbiology
Street address
Research Department, Tohid Hospital, Tohid Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6616813131
Phone
+98 87 3324 9435
Fax
+98 87 3324 9435
Email
p.sharifi@muk.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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