Comparison of the efficacy of oral Trigonella foenum-graecum seed extract and oral azithromycin in the severity of acne vulgaris; a randomized controlled clinical trial
The study conduct to determine the effect of Trigonella foenum-graecum on acne vulgaris. 20 patients with clinical diagnosis of acne vulgaris will refer to the dermatology department of the shahid faghihi hospital. Patients in the study must have mild to moderate acne (GAGS: 1-30) and aged 12 to 30 years old.
Participants either will receive two oral capsules each one containing 500 mg hydroalcoholic extract of Trigonella Foenum-graecum (fenugreek) seed or two azithromycin capsule (each one 125mg azithromycin) daily for two months. The azithromycin capsules will be similar in color, shape, size, and package to the fenugreek capsules. We will evaluate patients 30 and 60 days after starting of the trial to reassess clinical changes and ask them about any potential side effects (Such as allergic reactions, bloating, transient diarrhea, severe weight loss, hypoglycemia, dizziness and cold sweats).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015091123978N1
Registration date:2017-11-05, 1396/08/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-05, 1396/08/14
Registrant information
Name
Ali Mohammadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 5410
Email address
mohamad_al@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of oral Trigonella foenum-graecum seed extract and oral azithromycin in the severity of acne vulgaris; a randomized controlled clinical trial
Public title
Effect ot Fenugreek in treatment of Acne Vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 12 to 30 years; GAGS score between 1 and 30; signature consent form.
Exclusion criteria: previous consumption of oral acne controller medications, such as antibiotics, isotretinoin, oral contraceptive pills; administration of drugs that caused acne such as testosterone, progesterone, steroids, lithium, phenytoin, and isoniazid; patients with symptoms of endocrine disorders especially hyperandrogegism, including polycystic ovarian syndrome (oligomenorrhea, polycystic ovaries, hirsutism), Cushing syndrome (rapid weight gain, buffalo hump, moon face, excess sweating, purple or red striae on the body and hirsutism), CAH, androgen-secreting tumors, and acromegaly; severe skin problem; women who were pregnant or lactating.
Age
From 12 years old to 30 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
71345-1583
Approval date
2014-09-02, 1393/06/11
Ethics committee reference number
CT-P-9362-6852
Health conditions studied
1
Description of health condition studied
Acne vulgaris
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris
Primary outcomes
1
Description
Severity of skin lesions
Timepoint
At baseline, 30 and 60 days after intervention
Method of measurement
Global Acne Grading System (GAGS)
Secondary outcomes
1
Description
changes in lesions count (total, inflammatory, non-inflammatory and regional)
Timepoint
At baseline, 30 and 60 days after intervention
Method of measurement
visual counting
Intervention groups
1
Description
Intervention group, in addition to diet and hygienic recommendations, use capsules containing fenugreek hydro alcoholic extract 1g / d for 2 months.
Category
Treatment - Drugs
2
Description
Control group, in addition to diet and hygienic recommendations, use Azithromycin capsules 250mg/d for 2 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faghihi Hospital
Full name of responsible person
Mojdeh Sepaskhah
Street address
Zand street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Karim khan zand street, Shiraz University of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz university of medical science
Full name of responsible person
Ali Mohammadi
Position
Medical Student
Other areas of specialty/work
Street address
Zand street, School of Medicine
City
Shiraz
Postal code
Phone
+98 917 736 9270
Fax
Email
dr.mohammadi71@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mojdeh Sepaskhah
Position
Assistant Professor of Dermatology
Other areas of specialty/work
Street address
Karim Khan Street, Faghighi Hospital, Molecular Dermatology research center
City
Shiraz
Postal code
Phone
+98 71 3212 5592
Fax
Email
Sepaskhah_m@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Amir Hossein Babaei
Position
Medical Student
Other areas of specialty/work
Street address
Zand street, School of Medicine
City
Shiraz
Postal code
Phone
+98 917 739 5073
Fax
Email
babaei93@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)