Protocol summary
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Study aim
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Evaluation of oral N-acetylcysteine administration on reduction of oxidative stress, heavy metal concentration and serum lipid profile in women with endometriosis
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Design
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This is a parallel, non-blinded, randomized controlled clinical trial
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Settings and conduct
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this study will be done at the Fatemezahra Infertility Center of Babol University of Medical Sciences. Sixty women with endometriosis will be divided into two groups (30 in each group), intervention group will be received routine treatment with n-acetylcysteine and comparison group received routine treatment. Index of lipid peroxidation, total antioxidant capacity and carbonyl will be measured. Determination of iron and lactate dehydrogenase in blood samples of patients by spectrophotometric method and determination of 8-hydroxy-2-doxy guanosine as an indicator of DNA oxidative stress by ELISA and heavy metals by atomic absorption and lipid indices Spectrophotometry will be performed.
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Participants/Inclusion and exclusion criteria
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Endometriosis, 20-45 years old, not taking antioxidants and non-clinical, or surgical treatment in the past 6 months, no chronic diseases such as: hepatitis, thalassemia anemia, diabetes , infectious diseases and Inflammatory.
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Intervention groups
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The experimental group will receive routine treatment and a 6-week oral administration of N-acetylcysteine at a daily dose of 8.1 g daily (3 g daily for obese women). The control group will receive only routine treatment.
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Main outcome variables
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Malondialdehyde, lactate dehydrogenase, total antioxidant capacity, zinc, copper, lead, cadmium, nickel, chromium and lipid indices.
General information
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Reason for update
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Modification of sample age and incorrect typing correction
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20100411003684N9
Registration date:
2020-01-27, 1398/11/07
Registration timing:
registered_while_recruiting
Last update:
2020-05-16, 1399/02/27
Update count:
1
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Registration date
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2020-01-27, 1398/11/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice-Chancellor for research of Babol University of Medical Sciences
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Expected recruitment start date
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2019-09-22, 1398/06/31
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Expected recruitment end date
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2020-09-21, 1399/06/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Eeffect of oral administration of N- acetyl cysteine on decrease of oxidative stress , Concentration of heavy metals and lipid profile in Women with Endometriosis
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Public title
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Eeffect of oral administration of N- acetyl cysteine in Women with Endometriosis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Women with endometriosis
َAge 20-35 years old
Laparoscopic diagnosis of endometriosis
Not taking antioxidant supplements
Lack of chronic diseases such as: diabetes- hepatitis- thalassemia anemia-infectious and inflammatory diseases
No clinical or surgical treatment for the past six months
Lack of polycystic ovary
Exclusion criteria:
Non-use of medication
Thalassemia. Diabetes- Hepatitis- Anemia-Infectious and Inflammatory diseases.
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Age
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From 20 years old to 35 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2012-12-09, 1391/09/19
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Ethics committee reference number
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MUBABOL.HRI.REC.1393.1671
Health conditions studied
1
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Description of health condition studied
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Endometriosis
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ICD-10 code
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N80.8
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ICD-10 code description
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Other endometriosis
Primary outcomes
1
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Description
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Malondialdehyde (MDA)
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Timepoint
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6 Weeks
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Method of measurement
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TBARS Method (Spectrophotometry)
2
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Description
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Total antioxidant capacity (TAC)
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Timepoint
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6 Weeks
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Method of measurement
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FRAP Method
3
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Description
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Blood Iron
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Timepoint
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6 Weeks
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Method of measurement
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Spectrophotometry
4
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Description
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Lactate dehydrogenase (LDH)
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Timepoint
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6 Weeks
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Method of measurement
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Spectrophotometry
5
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Description
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8-OH-2-deoxy-Guanosine (8-OHdG)
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Timepoint
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6 Weeks
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Method of measurement
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ELISA
6
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Description
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Carbonyl
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Timepoint
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6 Weeks
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Method of measurement
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Levin Method
7
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Description
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DPPH index
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Timepoint
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6 Weeks
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Method of measurement
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Spectrophotometry
Secondary outcomes
1
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Description
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Levels of Lead
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Timepoint
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6 week
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Method of measurement
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Atomic absorption
2
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Description
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Levels of cadmium
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Timepoint
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6 Week
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Method of measurement
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Atomic absorption
3
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Description
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Levels of nickel
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Timepoint
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6 Week
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Method of measurement
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Atomic absorption
4
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Description
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Levels of chromium
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Timepoint
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6 Week
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Method of measurement
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Atomic absorption
5
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Description
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Levels of High Density Lipoprotein (HDL)
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Timepoint
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6 Week
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Method of measurement
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Spectrophotometer
6
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Description
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Levels of Low Density Lipoprotein (LDL)
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Timepoint
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6 Week
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Method of measurement
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Spectrophotometer
7
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Description
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Levels of Triglyceride
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Timepoint
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6 Week
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Method of measurement
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Spectrophotometer
8
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Description
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Levels of Cholesterol
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Timepoint
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6 Week
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Method of measurement
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Spectrophotometer
9
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Description
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Levels of Cu
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Timepoint
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6 Week
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Method of measurement
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Spectrophotometer
10
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Description
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Levels of Zn
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Timepoint
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6 Week
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Method of measurement
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Spectrophotometer
11
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Description
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Levels of Zn
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Timepoint
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6 Week
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Method of measurement
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Spectrophotometer
12
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Description
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Level of Carbonyl
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Timepoint
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6 Week
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Method of measurement
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Spectrophotometer
13
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Description
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DPPH Index
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Timepoint
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6 Week
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Method of measurement
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Spectrophotometer
Intervention groups
1
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Description
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Oral administration of N- acetyl cysteine with dose of 1/8 gr/day (overweight women 3 gr/day) during 6 weeks in addition to routine medication in women with endometriosis.
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Category
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Treatment - Drugs
2
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Description
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The control group will be received routine medication.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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913438
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Babol University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Data on the main outcome will be available
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When the data will become available and for how long
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Six months after the publication of result
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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It is not yet known
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From where data/document is obtainable
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professor Soleiman Mahjoub
smahjoub20@yahoo.com OR s.mahjoub@mubabol.ac.ir
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What processes are involved for a request to access data/document
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Two weeks after application
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Comments
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