Protocol summary
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Study aim
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Objective of this study: The results proved the effectiveness of the herbal composition on sex hormones as well as prolactin in infertile men.
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Design
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Clinical trial, single-blind and comparative
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Settings and conduct
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This study was performed during 2014-2015 in the infertility clinic of Umm Leila in Bandar Abbas. Fifty infertile men aged 22-42 years were randomly selected by inclusion criteria and 30 patients in the intervention group received two 500 mg capsules daily including herbal composition. The 20 patients in the control group received a placebo twice a day, in the morning and evening for three consecutive months.
At the end of the three-month period, the ability of sperm and sex hormones and prolactin criteria in the intervention group was evaluated and compared with before taking herbal supplements and the control group. The person collecting information and analyzing the study was completely blind to all the information of the groups and the intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: infertile men between 22 and 42 years of age, sperm count < 20 million per milliliter, morphology < 20%, progressive motility < 50%
Exclusion criteria: varicocele, testicular atrophy, azoospermia.
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Intervention groups
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The intervention group, besides a standard infertility medical treatment prescribed by a physician, received two 500mg capsules on a daily basis containing an herbal composition of palm pollen essence (350 mg) and black seed powder (250 mg) in the morning and at night for 3 months.
Control group: In addition to receiving standard infertility medication, patients also received two 500 mg placebo capsules in the morning and night for three months.
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Main outcome variables
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Changes in sperm parameters, sex hormones and prolactin
General information
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Reason for update
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Edition and revision of the research methodology: As these data describe an invention, The content needs to be updated now. Thus, it received a new ethical code from the ethical committee
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2015020120895N1
Registration date:
2015-11-08, 1394/08/17
Registration timing:
retrospective
Last update:
2021-09-24, 1400/07/02
Update count:
1
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Registration date
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2015-11-08, 1394/08/17
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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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Hormozgan University of Medical sciences
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Expected recruitment start date
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2015-01-31, 1393/11/11
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Expected recruitment end date
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2015-06-22, 1394/04/01
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Actual recruitment start date
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2015-01-31, 1393/11/11
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Actual recruitment end date
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2015-06-22, 1394/04/01
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Trial completion date
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2015-06-22, 1394/04/01
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Scientific title
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The effect of Herbal composition on sex hormones level: a Single-blinded, comparative controlled clinical trial
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Public title
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Evaluating the effect of an herbal complement on sex hormones in infertile men
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Infertile men between 22 and 42 years of age
No allergy to the consumption of herbal medicines
Sperm count less than 20 million per milliliter
morphology < 20%
progressive motility < 50%
Exclusion criteria:
history of genetic disorder
anomaly in reproductive system
Consumption of fertilizing drugs for at least 6 months before participating in this study
Varicocele
Testicular atrophy
Azospermia
Ejaculation disorder
Candidate for intracytoplasmic injection of sperm
unwillingness to take part in the study
trauma to testicles
alcohol abuse
history of systemic disorder
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Age
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From 22 years old to 42 years old
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Gender
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Male
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
62
Actual sample size reached:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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A simple randomization is provided with a sealed envelope.
In this method, a number of cards selected by the researcher as the intervention group and the same number of cards for the control group are considered; Then, by merging the cards together (flipping the cards), a card is taken out and its allocation is recorded, and that card is returned to the other cards after being taken out. The cards are then merged again and another card is removed. This process continues until a random sequence is reached according to the sample size.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The data collector who evaluates the outcome has no information about the coded packets and their contents and does not know what kind of intervention the intervention group and the control group will receive.
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Placebo
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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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2016-03-04, 1394/12/14
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Ethics committee reference number
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IR.HUMS.REC.1394.201
Health conditions studied
1
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Description of health condition studied
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Male infertility
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ICD-10 code
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N46.1
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ICD-10 code description
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Oligospermia
Primary outcomes
1
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Description
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Sperm Motility
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Timepoint
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Before the intervention and three months after the intervention
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Method of measurement
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Determination of sperm motility using CASA computer system
2
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Description
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Sperm count
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Timepoint
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Before the intervention and three months after the intervention
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Method of measurement
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Determination of sperm count using CASA computer system
3
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Description
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The amount of LH
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Timepoint
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Before the intervention and three months after the intervention
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Method of measurement
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Measurement of LH by Radioimmunoassay
4
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Description
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The amount of FSH
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Timepoint
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Before the intervention and three months after the intervention
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Method of measurement
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Measurement of FSH by radioimmunoassay
5
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Description
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The amount of prolactin
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Timepoint
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Before the intervention and three months after the intervention
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Method of measurement
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Measurement of prolactin by Radioimmunoassay
Intervention groups
1
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Description
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The intervention group, besides a standard treatment prescribed by an urologist, received two 500 mg capsules containing 350 mg of pollen essence powder and 250 grams of black seed powder every morning and night for three months. Within 90 days, every patient received 180 capsules in sealed coded envelopes. The herbal composition capsules were manufactured by the Golbadistan Company.
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Category
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Treatment - Drugs
2
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Description
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The control group received 180 capsules of placebo(500 mg) in the same shape and color as the medicine used in the intervention group besides the standard treatment for 3 months. The placebo was manufactured by Golbadistan Company.
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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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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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Bandare-abbas 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available