Investigating the effect of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverumherbal capsules on the treatment of fungal and bacterial infections and wound healing and vaginal inflammations
Investigating the effect of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverum herbal capsules on the treatment of fungal, bacterial infections and vaginal inflammations
Design
After obtaining permission, the case group of 100 people and the control group of 100 people who have been proven to have vaginal infections will enter the study. Vaginal infections before and after the intervention will be investigated by clinical examination by a gynecologist and pap smear test.
Pap smear will be taken before the intervention and 4 weeks after the treatment. The intervention group was prescribed herbal capsules of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverum (one vaginally every night) in separate groups and only placebo was prescribed to the control group.
Settings and conduct
After obtaining permission, the case group of 100 people and the control group of 100 people who have been proven to have vaginal infections will enter the study. Vaginal infections before and after the intervention will be investigated by clinical examination by a gynecologist and pap smear test.
Pap smear will be taken before the intervention and 4 weeks after the treatment. The intervention group was prescribed herbal capsules of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverum (one vaginally every night) in separate groups and only placebo was prescribed to the control group.
Participants/Inclusion and exclusion criteria
The sample's vaginitis has been recorded by a gynecologist.
the age group of 20-50 years
be married
Intervention groups
There are 100 married women in Isfahan who refer to women's specialist clinic due to vaginal infections.
Main outcome variables
Fungal infections، bacterial infections and inflammation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131110015349N4
Registration date:2023-06-11, 1402/03/21
Registration timing:registered_while_recruiting
Last update:2023-06-11, 1402/03/21
Update count:1
Registration date
2023-06-11, 1402/03/21
Registrant information
Name
Maryam Allahdadian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1668 7140
Email address
allahdadian@iaufala.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-10, 1402/03/20
Expected recruitment end date
2023-09-11, 1402/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverumherbal capsules on the treatment of fungal and bacterial infections and wound healing and vaginal inflammations
Public title
Investigating the effect of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverumherbal capsules on the treatment ofvaginal infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Have a history of diseases that weaken the immune system, diabetes, or metabolic diseases.
They are taking chemical drugs for vaginitis.
Unwilling patients will be excluded from the study.
Exclusion criteria:
Age
From 20 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were assigned to intervention and control groups by throwing a coin (line or lion).
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants and the clinical caregiver did not know whether they were in the drug or placebo group
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad University- Najafaba Branch
Street address
Research Ethics Committees of Islamic Azad University- Najafaba Branch
City
Najafabad
Province
Isfehan
Postal code
۸۵۱۴۱۴۳۱۳۱
Approval date
2022-09-29, 1401/07/07
Ethics committee reference number
IR.IAU.NAJAFABAD.REC.1401.121
Health conditions studied
1
Description of health condition studied
Inflammatory disease of cervix uteri
ICD-10 code
N72
ICD-10 code description
Inflammatory disease of cervix uteri
2
Description of health condition studied
Candidiasis of vulva and vagina
ICD-10 code
B37.3
ICD-10 code description
Candidiasis of vulva and vagina
3
Description of health condition studied
Vaginitis
ICD-10 code
N76.0
ICD-10 code description
Acute vaginitis
Primary outcomes
1
Description
inflammation
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Pap smear result
2
Description
Fungal infections
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Pap smear result
3
Description
Bacterial infection
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Pap smear result
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, "the effect of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverumherbal capsules from Daru Derman Mehsan Nafis with limited responsibility by registration number 4831 on the dependent variables of fungal and bacterial infections and vaginal inflammations in women is investigated. On the other hand, the study will be conducted in case and control groups, and the allocation of control and case groups was random. This clinical trial, double-blind, placebo-controlled, and two-group before and after, will be conducted on 100 people with vaginal infections who will visit the women's office in Isfahan during 2014.
Category
Treatment - Drugs
2
Description
Control group: In the control group, a pap smear was taken first, and then a placebo was given to the patient, and after one month the results of the pap smear were checked.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecologist's office
Full name of responsible person
maryam allahdadian
Street address
Falavarjan, Islamic Azad University
City
Isfahan
Province
Isfehan
Postal code
8451731167
Phone
+98 31 3742 0134
Fax
Email
maryamallahdadian@yahoo.com
Web page address
https://falavarjan.iau.ir/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
maryamallahdadian
Street address
Falavarjan,Islamic Azad University
City
Isfahan
Province
Isfehan
Postal code
8451731167
Phone
+98 31 3742 0134
Email
maryamallahdadian@yahoo.com
Web page address
https://falavarjan.iau.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mahsan Nafis Pharmaceutical Co., Ltd
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Allahdadian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Basij Boulevard, Islamic Azad University, Falavarjan branch
City
Isfahan
Province
Isfehan
Postal code
8451731167
Phone
+98 31 3742 0134
Email
maryamallahdadian@yahoo.com
Web page address
https://falavarjan.iau.ir/fa
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Allahdadian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Basij Boulevard, Islamic Azad University, Falavarjan branch
City
Isfahan
Province
Isfehan
Postal code
8451731167
Phone
+98 31 3742 0134
Email
maryamallahdadian@yahoo.com
Web page address
https://falavarjan.iau.ir/fa
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Allahdadian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Basij Boulevard, Islamic Azad University, Falavarjan branch
City
Isfahan
Province
Isfehan
Postal code
8451731167
Phone
+98 31 3742 0134
Email
maryamallahdadian@yahoo.com
Web page address
https://falavarjan.iau.ir/fa
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
confidentiality
Study Protocol
No - There is not 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available