Protocol summary

Summary
The aim of study is Comparision the effect of Quercus Oak in contraction of vaginal muscles in women with Vaginal Relaxation. 120 persons of the women with relaxation of vaginal muscles, since2012-05-21 to 22/8/2012 candidate surgery colporaphy and get married at the first step to be considerate. But didnt history of chronic disease (diabetes, blood pressure, heart) at himself and husband and it haven’t sexual problems at himself (sexual unable, premature ejaculation) and haven’t genito urinary infection . Sampling be done as chance of have feature unite of to be considerate and be done as quota according to number of references to center. After to explain goals of search to simple and give aware testimonial for to participate in study, all of the women for to certain degree of prolapsed to classify in position of Litotomy Check up and according to pelvic prolapsed pop_Q standard and form of questionnaire number1 (information of disease demographic), questionnaire number2 (questionnaire sexual satisfaction PISQ), and to be complete before to be prescription gel vaginal extract of quercus oak in clinic same center educational by disease.All interventional groups one certain dose (10-15 and 20 gr with 1/5%-2%AND 2/5%) were recived.In contorl group was recived basic jell without extract. In all of the patterns, these extract uses in 3days time after finish to be period and before sexual contact as vaginal.. After last doses use order to sexual contact . One day after uses gel, diseases to be considerate about affective of drug and probably advers effect of drug to be recorded .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138804071842N2
Registration date: 2012-11-26, 1391/09/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-11-26, 1391/09/06
Registrant information
Name
Nahid Lorzadeh
Name of organization / entity
Lorestan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 1420 6099
Email address
lorzadeh.n@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Lorestan University Of Medical Sciences
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Quercus Oak in contraction of Vaginal Muscles in women with Vaginal Relaxation
Public title
The Effect of Quercus oak in Treatment o f Vaginal Relaxation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: pelvic organ prolapsed; relaxation of vaginal muscles; get married Exclusion criteria: chronic disease (diabetes, blood pressure, heart) at himself and husband; sexual problems (sexual unable, premature ejaculation); infection of genitourinary Tract
Age
From 18 years old to 50 years old
Gender
Female
Phase
1
Groups that have been masked
None
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Lorestan University Of Medical Sciences
Street address
Reserch Center, Kamalvand Street
City
Khoramabad
Country
Iran (Islamic Republic of)
Postal code
Approval date
2011-10-25, 1390/08/03
Ethics committee reference number
200/56146

Health conditions studied

1

Description of health condition studied
vaginal relaxation
ICD-10 code
N81
ICD-10 code description
Female genital prolapse

Primary outcomes

1

Description
contraction of vaginal smooth muscles
Timepoint
Before and one day after intervention
Method of measurement
PISQ Standard questionary

Secondary outcomes

1

Description
Adverse effects (pain,burn)
Timepoint
One day after intervention
Method of measurement
Standard Questionary

Intervention groups

1

Description
First group was received 10 gr Quercus oak extract 1/5% for 3 days in vaginal form .
Category
Treatment - Drugs

2

Description
secound group was received 15 gr Quercus oak extract 2 % for 3 days in vaginal form
Category
Treatment - Drugs

3

Description
Third group was received 20 gr Quercus oak extract 2/5 % for 3 days in vaginal form
Category
Treatment - Drugs

4

Description
contorl group was recived basic jell without extract for 3days time after finish to be period and before sexual contact as vaginal
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Asali Hospital
Full name of responsible person
Nahid Lorzadeh
Street address
No2, salashour avenue, Enghlab street
City
Khoramabad
Country
Iran (Islamic Republic of)

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Razi Herbal Drug Center Of Lorestan University Of Medical Sciences
Full name of responsible person
Mohamadhasan Kayedi
Street address
Herbal Drug Center, Shafa Street
City
Khoramabad
Country
Iran (Islamic Republic of)
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi Herbal Drug Center Of Lorestan 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
Lorestan University Of Medical Sciences
Full name of responsible person
Nahid Lorzadeh
Position
Associate Prof
Other areas of specialty/work
Street address
Asali Women Hospital
City
Khoramabad
Country
Iran (Islamic Republic of)
Postal code
Phone
+98 66 1320 1790
Fax
Email
nahid442000@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Lorestan University Of Medical Sciences
Full name of responsible person
Nahid Lorzadeh
Position
Associate Prof
Other areas of specialty/work
Street address
Asali Women Hospital, Ghasiabad
City
Khoramabad
Country
Iran (Islamic Republic of)
Postal code
Phone
+98 66 1320 1790
Fax
Email
nahid442000@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
Nahid Lorzadeh
Position
Associate prof
Other areas of specialty/work
Street address
No 2, salashour avenue, Enghlab street
City
Khoramabad
Country
Iran (Islamic Republic of)
Postal code
6816787147
Phone
+98 66 1320 1790
Fax
+98 66 1320 4519
Email
nahid442000@yahoo.com
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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