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Comparison of Nigella sativa versus Clotrimazole in remedy of Vaginal Candidiasis

Protocol summary

Summary
Objective: comparison of Nigella sativa versus Clotrimazole in remedy of Vaginal Candidiasis. Design: Randomize, Single blind, Interventional, Without placebo. Inclusion criteria: Married women between 18-49 years old; Patients who had a single sexual partner and they themselves were the only sexual partner of their respective spouse; Women who had not used antibiotics, immunosuppressive drugs, vaginal drugs 14 days before the study; Patients who were not at pregnancy or breast-feeding stage and did not consume alcohol. Exclusion criteria: patients with pregnancy, diabetes and immunodeficiency. Target sample size: 100 People. Primary outcome measure: Vaginal wall secretion, In the first visit and 7 to 14 days after first visit, By using speculum. Intervention group: Nigella sativa suppository, 2%, once a day for a week. Control group: Clotrimazole suppository, 100 ml, once a day for a week

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014111920001N1
Registration date: 2014-12-30, 1393/10/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-12-30, 1393/10/09
Registrant information
Name
Nafiseh Saghafi
Name of organization / entity
Ghaem Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 4499
Email address
saghafin@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2006-06-01, 1385/03/11
Expected recruitment end date
2007-03-01, 1385/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Nigella sativa versus Clotrimazole in remedy of Vaginal Candidiasis
Public title
Treatment of Vaginal Candidiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Married women between 18-49 years old; Patients who had a single sexual partner and they themselves were the only sexual partner of their respective spouse; Women who had not used antibiotics, immunosuppressive drugs, or vaginal drugs 14 days before the study; Patients who were not at pregnancy or breast-feeding stage and did not consume alcohol. Exclusion criteria: patients with pregnancy, diabetes and immunodeficiency.
Age
From 18 years old to 49 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice chancellor for research, Mashhad University of Medical Sciences
Street address
Ghoreishi building, Daneshgah St, Vice chancellor of research, Mashhad
City
Mashhad
Postal code
Approval date
2005-08-17, 1384/05/26
Ethics committee reference number
84138

Health conditions studied

1

Description of health condition studied
Vaginal Candidiasis
ICD-10 code
B37.3
ICD-10 code description
Candidiasis of vulva and vagina

Primary outcomes

1

Description
Vaginal wall secretion
Timepoint
In the first visit and 7 to 14 days after first visit
Method of measurement
By using speculum

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Nigella sativa suppository, 2%, once a day for a week.
Category
Treatment - Drugs

2

Description
Control group: Clotrimazole suppository, 100 ml, once a day for a week.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Nafiseh Saghafi
Street address
Ghaem Hospital, Ahmadabad St, Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of medical Sciences
Full name of responsible person
Mohammad Ramezani
Street address
Ghoreishi building, Daneshgah St, Vice chancellor of research, Mashhad
City
Mashhad
Grant name
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad 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
Ghaem Hospital
Full name of responsible person
Nafiseh Saghafi
Position
Assistant Professor
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmadabad St, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3840 0001
Fax
Email
Quaem.Medical.Center@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ghaem Hospital
Full name of responsible person
Nafiseh Saghafi
Position
Assistant Professor
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmadabad St, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3840 0001
Fax
Email
saghafin@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ghaem Hospital
Full name of responsible person
Nafiseh Saghafi
Position
Assistant professor
Other areas of specialty/work
Street address
Ghaem Hospital, Ahmadabad St, Mashhad
City
Mashhad
Postal code
Phone
+98 51 3840 0001
Fax
Email
saghafin@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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