Comparison of the effect of curcumin tablets with metronidazole tablets on the treatment of bacterial vaginosis
Design
This study is a clinical trial. By referring to women's outpatient clinics in Alborz province, 90 eligible people are selected to enter the study. Without blinding, sampling is done by simple random sampling. One group is given metronidazole 500 tablets and the other group is given 40 nano curcumin capsules. Participants in both groups come 2 weeks after taking the medication to check for improvement.
Settings and conduct
Methods: If the disease is confirmed in eligible individuals, patients will be randomly divided into two groups of metronidazole 500 tablets and curcumin nano 40 capsules (every 12 hours for 7 nights).collection place: Women's outpatient clinics in Alborz province
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Age 18- 49 years
2. Being married
3- Lack or absence
4 - No pregnancy and lactation
5- Proof of bacterial vaginosis
6- Not having allergies to curcumin (turmeric) or other medicinal plants
7. No history of known chronic disease
8. Not using herbal medicines and chemicals related to the treatment of genital infections during the last two weeks
9 - No active gastrointestinal ulcers and also no bile problems and gallstones
Exclusion criteria:
1- Getting pregnant during treatment
2. The presence of other vaginal infections
3. Complications or allergies to curcumin
4. The reluctance of the participant to continue the research
Intervention groups
Intervention group: 45 people with bacterial vaginosis who use curcumin nano 40 capsule instead of metronidazole treatment.
Control group: 45 people with bacterial vaginosis who receive routine treatment with metronidazole 500.
Main outcome variables
Improve the symptoms of bacterial vaginosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120414009463N61
Registration date:2020-12-02, 1399/09/12
Registration timing:registered_while_recruiting
Last update:2020-12-02, 1399/09/12
Update count:0
Registration date
2020-12-02, 1399/09/12
Registrant information
Name
Zahra Behboodi Moghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
behboodi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
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
Comparison of the effect of curcumin tablets with metronidazole tablets on the treatment of bacterial vaginosis
Public title
Comparison of the effect of curcumin tablets with metronidazole tablets on the treatment of bacterial vaginosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Age 18- 49 years
2. Being married
3 - Do not be menopause
4 - No pregnancy and lactation
5- proof of bacterial vaginosis
6- Not having allergies to curcumin (turmeric) or other medicinal plants
7. No history of known chronic disease
8. Not using herbal medicines and chemicals related to the treatment of genital infections during the last two weeks
9 - No active gastrointestinal ulcers and also no bile problems and gallstones
Exclusion criteria:
1.Pregnancy during treatment
2. The presence of other vaginal infections
3. Complications or allergies to curcumin
4. The reluctance of the participant to continue the research
5 - not following the correct method of treatment (forgetting to take medicine for more than one night)
6- Use of systemic antibiotics to treat non-bacterial systemic infection during treatment
Age
From 18 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling of this study will be random using block method. In this way, all eligible people enter the study after providing complete explanations and obtaining informed consent and are randomly placed in one of the two intervention or control groups with a quadruple blocking method. In this way, we will consider the letter A for the intervention group and the letter B for the control group. Then write all the permutation compounds of the letters A, A and B, B, which are 6 combinations (AABB for combination 1, ABBA for combination 2, etc.) and from combinations 1 to 6, a combination will be randomly selected. . For example, if combination 1 is selected, it means that the first and second people will be in the intervention group and the third and fourth people will be in the control group. Sampling will continue until the desired number of samples in each group is reached.
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 of Tehran University of Medical Sciences and Health Services
Street address
Keshavarz Boulevard, corner of Quds Street, central building
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-12-22, 1398/10/01
Ethics committee reference number
IR.TUMS.FNM.REC.1399.093
Health conditions studied
1
Description of health condition studied
Bacterial vaginosis treatment
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Vaginosobacterial treatment with nanocurcumin 40 capsules
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The primary outcome is the percentage of people who have improved after taking oral curcumin tablets to treat bacterial vaginosis.
Timepoint
Periods of disease evaluation, before the intervention and two weeks after starting metronidazole and curcumin tablets
Method of measurement
Existence of three of Amsel's four standard signs
Secondary outcomes
empty
Intervention groups
1
Description
.Intervention group: Study participants who meet the inclusion criteria are treated with 40 nanocurcumin capsules every 12 hours for one week.
Category
Treatment - Drugs
2
Description
Control group: Participants in the study who meet the inclusion criteria are treated with metronidazole 500 tablets every 12 hours for one week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Women's outpatient clinics in Alborz province
Full name of responsible person
Sakineh Mohammadi
Street address
School of Nursing and Midwifery - Tehran University of Medical Sciences - Nosrat Sharghi - Tohid Square - Tehran - Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4227
Fax
+98 21 6105 4537
Email
sm-golyas99@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saeed Goodarzi
Street address
Tehran, Enghelab Square, 16 Azar St., Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 2966 1717
Email
goodarzi_s@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
medical University Tehran
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
Tehran University of Medical Sciences
Full name of responsible person
Zahra Behboodi Moghadam
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery - Tehran University of Medical Sciences - Nosrat Sharghi - Tohid Square - Tehran - Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4227
Email
Behboodi@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sakine Mohammadi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery - Tehran University of Medical Sciences - Nosrat Sharghi - Tohid Square - Tehran - Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4227
Email
sm_golyas99@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sakineh Mohammadi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery - Tehran University of Medical Sciences - Nosrat Sharghi - Tohid Square - Tehran - Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4227
Email
sm_golyas99@ yahoo.com
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
I have not decided yet - the release schedule is not clear yet