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Determination of the effect of Gingko Biloba​ extract on redox state of human serum and aqueous albumin in patients with senile cataract

Protocol summary

Study aim
Determination of The effect of Gingko Biloba​ extract on redox state of human serum and aqueous albumin in patients with senile cataract
Design
Community based, parallel-group, double-blinded, randomised controlled trial
Settings and conduct
200mg GbE supplement capsules and identical placebo was prescribed to the patients for 6 months post-cataract surgery, patients and their study-groups were coded and followed up using slit-lamp examination at 6,12 and 36 months post-op and their Fibrotic and Pearl Posterior Capsule Opacification was surveyed and graded. Data analyses were conducted using the coded data, so the patients, care-giver and data analyst were all blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: senile cataract Exclusion criteria: a ​history of cardiac, renal, neurologic, hematologic, DM, thyroidal and rheumatologic diseases, Receiving of estrogen-steroid, immunosuppressive and anticoagulant-anti platelet agents, History of ophthalmic diseases and surgery such as uveitis, retinitis pigmentosa and trabeculectomy
Intervention groups
GBE, capsule 200 mg PO​, daily for 16weeks
Main outcome variables
Fibrotic Posterior Capsule Opacification Pearl Posterior Capsule Opacification

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190912044755N1
Registration date: 2019-10-10, 1398/07/18
Registration timing: retrospective

Last update: 2019-10-10, 1398/07/18
Update count: 0
Registration date
2019-10-10, 1398/07/18
Registrant information
Name
Ahmad Ahmadzadeh Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3332 5734
Email address
ahmadzdh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-02-19, 1393/11/30
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
2015-02-19, 1393/11/30
Actual recruitment end date
2018-10-22, 1397/07/30
Trial completion date
2019-04-19, 1398/01/30
Scientific title
Determination of the effect of Gingko Biloba​ extract on redox state of human serum and aqueous albumin in patients with senile cataract
Public title
Survey of the effect of Gingko Biloba on cataract
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Senile cataract
Exclusion criteria:
History of cardiac diseases History of renal diseases History of neurological diseases History of Diabetes Mellitus History of rheumatologic diseases History of hematologic diseases History of thyroid diseases Receiving of estrogen-steroid, immunosuppressive and anticoagulant-anti platelet agents History of ophthalmic diseases and surgery
Age
From 50 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 146
More than 1 sample in each individual
Number of samples in each individual: 2
1 or 2 eyes in each patient
Actual sample size reached: 134
More than 1 sample in each individual
Actual sample size in each individual: 2
1 or 2 eyes in each patient
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization on an individual level using 4 number blocks created in excel software. Allocation concealment has been carried out.
Blinding (investigator's opinion)
Double blinded
Blinding description
A placebo identical to the GbE capsules was provided to the patients, so neither the patient nor the physician were aware of the supplementation. Patients and their data were coded and documented using codes and data analysis was carried out using these codes.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
17th km Khazarabad Blv
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2011-12-21, 1390/09/30
Ethics committee reference number
90-114

Health conditions studied

1

Description of health condition studied
Senile cataract
ICD-10 code
H25
ICD-10 code description
Age-related cataract

Primary outcomes

1

Description
Posterior Capsule Opacification
Timepoint
6, 12, 36 weeks after cataract surgery
Method of measurement
Slit-lamp bio microscopic examination of eyes

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: GBE,capsule 200 mg po,daily for 16weeks
Category
Prevention

2

Description
Control group: placebo,capsule 200 mg po,daily for 16weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Boali sina hospital of sari
Full name of responsible person
Ahmad Ahmadzadeh Amiri
Street address
Pasdaran Blv
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3334 3011
Email
ahmadzdh@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Deputy of research and technology of Mazandaran University of Medical Sciences
Street address
17 Km of Khazar abad Blv
City
Sari
Province
Mazandaran
Postal code
919748471
Phone
+98 11 3354 3081
Email
ahmadzdh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
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
Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ahmadzadeh Amiri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Vitreoretinal fellowship
Street address
Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3332 5734
Fax
+98 21 2293 0953
Email
ahmadzdh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ahmadzadeh Amiri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Vitreoretinal fellowship
Street address
Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3332 5734
Fax
+98 21 2293 0953
Email
ahmadzdh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ahmadzadeh Amiri
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Vitreoretinal fellowship
Street address
Pasdaran Blvd
City
Sari
Province
Mazandaran
Postal code
4815838477
Phone
+98 11 3332 5734
Fax
+98 21 2293 0953
Email
ahmadzdh@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
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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