Protocol summary
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Study aim
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Investigating the effect of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverum herbal capsules on the treatment of fungal, bacterial infections and vaginal inflammations
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Design
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Clinical trial with control group, with parallel groups, single-blind, randomized, on 100 patients. which random number table was used for randomization. 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) produced by Daru Darman Mahsan Nafis with limited responsibility by registration number 4831, and the control group was prescribed only placebo.
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Settings and conduct
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Clinical trial with control group, with parallel groups, single-blind, randomized, on 100 patients. which random number table was used for randomization. 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) produced by Daru Darman Mahsan Nafis with limited responsibility by registration number 4831, and the control group was prescribed only placebo.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: samples were diagnosed with vaginitis by a gynecologist, age group 20-50 years, being married.
Do not enter: Allergy to herbal medicines
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Intervention groups
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There are 100 married women who refer to women's specialist clinic due to vaginal infections.
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Main outcome variables
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Fungal infections، bacterial infections and inflammation
General information
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Reason for update
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Please, the name of the company that provides the drug to the researcher should be mentioned in the summary of the trial placed on the site
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20131110015349N4
Registration date:
2023-06-11, 1402/03/21
Registration timing:
registered_while_recruiting
Last update:
2023-06-27, 1402/04/06
Update count:
1
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Registration date
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2023-06-11, 1402/03/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-06-10, 1402/03/20
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Expected recruitment end date
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2023-09-11, 1402/06/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the effect of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverumherbal capsules on the treatment of fungal and bacterial infections and wound healing and vaginal inflammations
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Public title
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Investigating the effect of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverumherbal capsules on the treatment ofvaginal infection
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
.Willingness to participate in the study
They have a vaginal infection
Exclusion 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
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Age
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From 20 years old to 50 years old
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Gender
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Female
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Phase
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2-3
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Groups that have been masked
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Sample size
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Target sample size:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, a simple randomization model was used, using a lottery. In this way, 100 people who came to the office and met the entry criteria were assigned a number, then all the numbers were thrown into a ball and one person was selected by lottery. The intervention group and one person was assigned to the control group
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Participants do not know whether they are in the drug or placebo group. The herbal medicine is powdered and poured into a dark capsule cover, so that the contents cannot be seen. Placebo capsules are filled with dark colored flour. The participant does not know whether the capsule they are receiving is placebo or treatment.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-09-29, 1401/07/07
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Ethics committee reference number
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IR.IAU.NAJAFABAD.REC.1401.121
Health conditions studied
1
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Description of health condition studied
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Inflammatory disease of cervix uteri
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ICD-10 code
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N72
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ICD-10 code description
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Inflammatory disease of cervix uteri
2
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Description of health condition studied
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Candidiasis of vulva and vagina
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ICD-10 code
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B37.3
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ICD-10 code description
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Candidiasis of vulva and vagina
3
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Description of health condition studied
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Vaginitis
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ICD-10 code
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N76.0
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ICD-10 code description
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Acute vaginitis
Primary outcomes
1
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Description
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Inflammation
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Timepoint
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Before the intervention and one month after the intervention
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Method of measurement
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Pap smear result
2
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Description
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Fungal infections
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Timepoint
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Before the intervention and one month after the intervention
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Method of measurement
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Pap smear result
3
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Description
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Bacterial infection
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Timepoint
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Before the intervention and one month after the intervention
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Method of measurement
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Pap smear result
Intervention groups
1
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Description
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Intervention group: In this study, "the effect of Quercus, Punicagranatum, Malvasylvestris, Cinnamomumverumherbal capsules from Daru Darman Mahsan 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, single-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 2023.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Daru Darman Mahsan Nafis with limited responsibility by registration number 4831
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Proportion provided by this source
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50
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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confidentiality
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available