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Effect of Vaginal Product of Descurainia sophia- Honey derived from Iranian Traditional Medicine on Clinical and Laboratory in Patients with Cervicitis

Protocol summary

Summary
Objective: To investigate the effect of vaginal product Descurainia Sophia- honey on clinical and laboratory findings of patients with cervicitis Design: before and after clinical trial Setting and conduct: After completing the questionnaire, patients will undergo vaginal examination by researcher and examination results will be recorded in a form designed by the researcher. A sample will be taken from patients who haven't experienced the Pap test within the past one year. Cervical and vaginal samples taken for culture and doctor will be sent to laboratories. 48 to 72 hours after complete administration of drugs, the samples will be again sent for culture. Participants: Patients aged between 17 and 55 with cervicitis diagnosed by gynecologist who wish to participate in the study. In case of pregnancy, lactation, addiction, history of pelvic surgery, cervical polyps, any other chronic disorder associated with cervical, previous Pap smear with abnormal cells, or concomitant use of herbal drugs for her illness, the patient will be excluded from the study. Interventions: After final diagnosis, patients will be treated with traditional medicine product Descurainia Sophia- honey for two weeks, an applicator of the medicine contents every night. Main outcome of the study: improvement in wound size and depth of the cervical ulcer.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015110824951N1
Registration date: 2016-01-13, 1394/10/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-01-13, 1394/10/23
Registrant information
Name
Razieh Nabimeybodi
Name of organization / entity
Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Me
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 8021
Email address
r.nabimeybodi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
School of Traditional Medicine and Materia Medica Research Center of Shahid Beheshti university of medical sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Vaginal Product of Descurainia sophia- Honey derived from Iranian Traditional Medicine on Clinical and Laboratory in Patients with Cervicitis
Public title
Effect of Vaginal Product of Descurainia sophia- Honey derived from Iranian Traditional Medicine on Clinical and Laboratory in Patients with Cervicitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women aged 17-55 with cervicitis; diagnosed by a gynecologist, who did not respond to antibiotic treatment or have relapsed during the past 6 months and are willing to participate in the study. Exclusion criteria: pregnancy; lactation; addiction; a history of pelvic surgery; cervical polyps; any other chronic disorder associated with cervix; previous Pap smear with abnormal cells; or concomitant use of herbal or chemical drugs for his illness. Exclusion criteria during the study that there is a Pap test result of abnormal cells; patients who are experiencing side effects; patients need to have surgery or other interventions; patients with a personal question have decided to withdraw from the study.
Age
From 17 years old to 55 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Formuation of drug in this study is derived from authoritative sources of Iranian Traditional medicine

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Beheshti University of Medical Sciences
Street address
Shahid Beheshti university of Medical Sciences, Shahid Chamran highway, Velenjak St
City
Tehran
Postal code
1516745811
Approval date
2015-09-06, 1394/06/15
Ethics committee reference number
IR.SBMU.RAM.REC.1394.165

Health conditions studied

1

Description of health condition studied
Cervicitis
ICD-10 code
N72
ICD-10 code description
Inflammatory disease of cervix uteri

Primary outcomes

1

Description
Cervical ulcer size
Timepoint
Before the intervention, after intervention
Method of measurement
Physical examination

2

Description
The depth of the ulcer
Timepoint
Before the intervention, after intervention
Method of measurement
Physical examination

Secondary outcomes

1

Description
Endocervical discharge culture
Timepoint
Before the intervention, after intervention
Method of measurement
Culture results based on laboratory results

2

Description
Vaginal discharge culture
Timepoint
Before the intervention, after intervention
Method of measurement
Culture results based on laboratory results

3

Description
Adenexal tenderness
Timepoint
Before the intervention, after intervention
Method of measurement
Physical examination

4

Description
discharge
Timepoint
Before the intervention, after intervention
Method of measurement
Physical examination and patient based on VAS

5

Description
burning
Timepoint
Before the intervention, after intervention
Method of measurement
VAS (visual analoge scale)

6

Description
Itching
Timepoint
Before the intervention, after intervention
Method of measurement
VAS

7

Description
Pain during intercourse
Timepoint
Before the intervention, after intervention
Method of measurement
Pos/Neg

8

Description
Post coital bleeding
Timepoint
Before the intervention, after intervention
Method of measurement
Pos/Neg

Intervention groups

1

Description
Use an applicator of traditional medicine products discurainia sophia honey for two weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Comprehensive Women's Arash hospital
Full name of responsible person
Nabimeybodi Razieh
Street address
next to police station, Rashid intersection, the second gate Tehranpars, Tehranpars, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
School of Traditional Medicine and Materia Medica Research Center Shahid Beheshti
Full name of responsible person
Tansaz Mojgan
Street address
No.8, Shams Alley, Opposite Street Tavanir, Vali Asr Street, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Traditional Medicine and Materia Medica Research Center Shahid Beheshti
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
Traditional Medicine and Materia Medica Research Center, Department of Traditional Medicine, School
Full name of responsible person
Nabimeybodi Razieh
Position
M.D,Ph.D Candidated of Iranian Traditional Medicine
Other areas of specialty/work
Street address
No.8, Shams Alley, opposite Street Tavanir, Vali Asr Street, Tehran
City
Tehran
Postal code
1516745811
Phone
00982188778028, 00982188773521
Fax
Email
r.nabimeybodi@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Me
Full name of responsible person
Tansaz Mojgan
Position
M.D, Ph.D Assistant Professor Department of Traditional Medicine
Other areas of specialty/work
Street address
No.8, Shams Alley, opposite Street Tavanir, Vali Asr Street, Tehran
City
Tehran
Postal code
1516745811
Phone
+98 21 8877 8028
Fax
Email
tansaz_mojgan@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Traditional Medicine, Traditional Medicine and Materia Medica Research Center, Shahid Behe
Full name of responsible person
Nabimeybodi Razieh
Position
MD/Ph.D candidated of Iranian Traditional Medicine
Other areas of specialty/work
Street address
No.8 Shams Alley, opposite Street Tavanir, Vali Asr Street, Tehran
City
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Fax
+98 21 8879 5008
Email
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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