Evaluation of the effect of Shalomine in treatment of candidal vaginitis
Design
Clinical trial with control group, with parallel groups, randomized, phase 2 on 30 patients. Random number table is used for randomization.
Settings and conduct
The samples include women with candidal vaginitis according to their clinical symptoms. After completing the informed consent form by the volunteer patients, the doctor take the vaginal sample using a sterile swab. The swabs transfer to the laboratory with dextrose broth and culture on specific medium of Chrom Candida agar. After positive candida culture and diagnosis of candidal vaginitis, patients are randomly allocated into two groups of 15 persons and are given shalomin (2 cc of the drug deep into the vagina with a sterile syringe twice a day for 5 days). The second group are given the clotrimazole daily for a week. At the end of the treatment period, clinical vaginal examinations and culture are performed and the two groups are compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: aged between 18 and 50 years: Married; Have a spouse ; Consent to participate in the study ; Lack of sensitivity to herbal drugs; Lack of sensitivity to clotrimazole; Being Literate.
Exclusion criteria: Taking antibiotics and corticosteroids in the last two weeks according to the participant's statements; Existence of any wound or mass in the cervix based on observation with speculum ; using other herbal medicines; Have abnormal uterine bleeding
Intervention groups
Patients with candidal vaginitis taking shalomin: patients with candidal vaginitis taking clotrimazole
Main outcome variables
Vaginitis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190728044356N1
Registration date:2020-12-07, 1399/09/17
Registration timing:registered_while_recruiting
Last update:2020-12-07, 1399/09/17
Update count:0
Registration date
2020-12-07, 1399/09/17
Registrant information
Name
Sousan Akrami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 7443
Email address
sahm647094@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of vaginal Shallomine containing pure fraction of shallot extract and clotrimazole in treatment of candidal vaginitis
Public title
Clinical trial on comparing the effect of vaginal Shallomine containing the pure fraction of shallot extract and clotrimazole in treatment of candidal vaginitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
aged between 18 and 50 years
Be married
Have 1 spouse
Have consent to participate in the study
Not allergic to herbal medicines
Not allergic to clotrimazole
Be literate
Exclusion criteria:
They have been taken antibiotics and corticosteroids for the past two weeks, according to the participant
Have any sores or lumps in the cervix based on observation with speculum
Present use of other herbal medicines
Have abnormal uterine bleeding
Age
From 18 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
This randomized controlled trial was designed in two parallel groups using a random block table of 8 blocks of 4. Random sequences were generated using WinPEPI (version 11.43) and the ratio assignment was 1: 1.
For example, block 1: 1: A 2: A 3: B 4: B
The codes are the letters A and B, the letter A being the test drug, and the letter B the control. The drugs were numbered sequentially, but the patient and physician did not know the codes. Codes are assigned to patients in the order of patient entry. After the results are announced, the numbers are matched by the epidemiologist with the codes and it is determined which number is related to the test and which number is related to the control.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research of Ahvaz Jundishapur University
Street address
University City, Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences and Health Services, Ground Floor
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Approval date
2020-10-26, 1399/08/05
Ethics committee reference number
IR.AJUMS.REC.1399.564
Health conditions studied
1
Description of health condition studied
Candidiasis
ICD-10 code
B37
ICD-10 code description
Candidiasis
2
Description of health condition studied
Candidiasis of vulva and vagin
ICD-10 code
B37.3
ICD-10 code description
Candidiasis of vulva and vagina
Primary outcomes
1
Description
Percentage of people with candidal vaginitis
Timepoint
Examination of Candida in the patient's vaginal discharge before the intervention and one week after taking the drug
Method of measurement
culture and Laboratory diagnosis of Candida
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Shalomine, 2 cc, deep vaginal inoculation with sterile syringe, twice daily for 5 days
Category
Treatment - Drugs
2
Description
Intervention group: Clotrimazole, daily for one week
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Obstetrics and Gynecology Clinic
Full name of responsible person
Raziyeh Mohammad Jafari
Street address
Naderi Street, between Ferdowsi and Hafez
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 61 3223 1317
Email
mohamadjafari-r@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mansour Amin
Street address
Ahvaz - Golestan Blvd., Shahr-e Daneshgahi, Esfand St., Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 61 3333 7077
Email
sahm647094@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Sousan Akrami
Position
student
Latest degree
Master
Other areas of specialty/work
Microbiology
Street address
Department of Microbiology, Ahvaz Jundishapur University of Medical Sciences, Esfand St., Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 61 3373 8283
Email
sahm647094@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mansour Amin
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Department of Medical Microbiology, Ahvaz Jundishapur University of Medical Sciences, Esfand St., Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 61 3373 8204
Email
mnsamin@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sousan Akrami
Position
student
Latest degree
Master
Other areas of specialty/work
Microbiology
Street address
Department of Medical Microbiology, Ahvaz Jundishapur University of Medical Sciences, Esfand St., Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
15794- 61357
Phone
+98 61 3373 8283
Email
s.akrami1992@gmail.com
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
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available