Objectives: Comparing the effectiveness and safety of cryotherapy in comparison with Chinese herbal medicine in the treatment of chronic cervicitis and cervical erosion.
Design: randomized Controlled Trial.
Setting and conduct: 70 patients with chronic cervicitis or cervical erosion referred to gynecology clinic of Imam Reza and Ghaem hospitals will be entered to the study. All subjects will be evaluated for study outcomes at 48 hours after treatment, week 1, 3 days after the end of menstruation, weeks 6 and 12.
Major Inclusion and Exclusion criteria: Cervicovaginal smears class 1 or 2; no report of papilloma or CIN).
Intervention: herbal treatment (experimental)and cryotherapy (control).
Main outcome measures: the cervicitis degree, side effects, complications and recurrence rate and the time of recovery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201512107265N4
Registration date:2016-06-14, 1395/03/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-14, 1395/03/25
Registrant information
Name
Hoda Azizi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1855 2188
Email address
azizih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research of Mashhad University of Medical Sciences
Expected recruitment start date
2015-12-19, 1394/09/28
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of cryotherapy in comparison with Chinese herbal medicine in the treatment of chronic cervicitis and cervical erosion
Public title
Efficacy and safety of cryotherapy in comparison with Chinese herbal medicine in the treatment of chronic cervicitis and cervical erosion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Developing chronic cervicitis or cervical erosion; Papanicolaou smear class 1 or 2; Normal colposcopy.
Exclusion criteria: Papanicolaou smear indicating papilloma or CIN; Sensitivity to plastic materials; Cervical prolapse greater than grade 1
Age
From 12 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Subjects will be randomly assigned to study groups using a random number table.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
MUM's central office, Daneshgah street, Mashhad
City
Mashhad
Postal code
Approval date
2012-03-14, 1390/12/24
Ethics committee reference number
900410
Health conditions studied
1
Description of health condition studied
Chronic cervicitis
ICD-10 code
N72
ICD-10 code description
Inflammatory disease of cervix uteri
Primary outcomes
1
Description
the degree of cervicitis
Timepoint
Before intervention, 48 hours after the intervention, one week after the intervention, 3 days after the end of the next menstruation and at weeks 6 and 12
Method of measurement
clinical examination of cervix (observation) and recording in the study check list
Secondary outcomes
1
Description
complications
Timepoint
48 hours after the intervention, one week after the intervention, 3 days after the end of the next menstruation and at weeks 6 and 12
Method of measurement
questionnaire
2
Description
Time to treatment response
Timepoint
Before intervention, 48 hours after the intervention, one week after the intervention, 3 days after the end of the next menstruation and at weeks 6 and 12
Method of measurement
clinical examination of cervix (observation) and recording in the study check list
Intervention groups
1
Description
Intervention group: Cervicitis Treatment Tray which is a patent made by Beijing Jinyongyuan Medical applianceco. It mainly contains Cortex Phellodendri. The herbal formulation is placed on a plastic tray which is geometrically compatible with cervix. The tray is passed through the vaginal spaculum and to be put on the cervix and removed 24 to 48 hours later.
Category
Treatment - Drugs
2
Description
Control group: cryotherapy
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology Clinic of Imam Reza Hospital
Full name of responsible person
Dr. Nayereh Khadem
Street address
Gynecology Clinic, Imam Reza Hospital, Ibn Sina Street
City
Mashhad
2
Recruitment center
Name of recruitment center
Gynecology Clinic of Ghaem Hospital
Full name of responsible person
Dr. Malihe hasanzade
Street address
Gynecology Clinic, Ghaem Hospital, Ahmadabad Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
MUM's central office, Daneshgah street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Department of Chinese and Complementary Medicine
Full name of responsible person
Dr Hoda Azizi
Position
MD, PhD in Acupuncture, Assistant Professor
Other areas of specialty/work
Street address
Center of Acupuncture and massage, Imam Reza Hospital
City
Mashhad
Postal code
Phone
+98 51 3855 2188
Fax
Email
azizih@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gynecology Research Center
Full name of responsible person
Dr Nayereh Khadem
Position
Gynecologist, Associate professor
Other areas of specialty/work
Street address
Gynecology Research Center, Imam Reza Hospital
City
Mashhad
Postal code
Phone
+98 51 3854 3031
Fax
Email
khademn@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hoda Azizi
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Chinese and Complementary Medicine
City
Mashhad
Postal code
Phone
+98 51 3855 2188
Fax
Email
azizih@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)