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The effect of Herbal composition on sex hormones level: a Single-blinded, comparative controlled clinical trial

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History
# Registration date Revision Id
2 2021-05-08, 1400/02/18 198956
1 2015-11-08, 1394/08/17 18450
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  • Protocol summary

    The aim of this study is evaluation of efficacy of phonix powder capsule on quality of sperm parameters of infertile men. Inclusion criteria is sperm count less than 20 million per mili liter; abnormal morphology; progressive motility less than 50 percent and exclusion criteria is varicocele; testicular atrophy; azoospermia; erectile dysfunction; candidate for ICSI (Intra Cytoplasmic Sperm Injection) ; consumption of alcohol; medications or opiods; unwillingness to partipate; death of the patient. Population target is patients refer to urology clinic in Shahid Mohammadi hospital. Phonix powder capsule 1 gram 4 times a day is given to the case group and the routine empirical medication is given to the control group. After 3 months, semenalysis is performed
    empty
    هدف از انجام این مطالعه تاثیر پودر گرده خرما بر کیفیت پارامترهای اسپرم مردان نابارور می باشد، معیار ورود، تعداد اسپرم کمتر از 20 میلیون در میلی لیتر؛ موفولولوژی کمتر از 20 درصد؛ تحرک پیشرونده کمتر از پنجاه درصد و معیار خروج از مطالعه، واریکوسل؛ آتروفی بیضه؛ آزواسپرمی؛ اخلال در انزال؛ کاندید تزریق داخل سیتوپلاسمی اسپرم ؛ مصرف هرگونه داروالکل یا مواد مخدر؛ عدم تمایل بیمار؛ فوت بیمار خواهد بود. جمعيت مورد مطالعه افراد مراجعه کننده به کلینیک اورلوژی بیمارستان شهید محمدی خواهد بود و حجم نمونه 50 نفر خواهد بود گروه شاهد درمان مرسوم ناباروری شامل ویتامین E و ال کارنیتین را دریافت می کنند و گروه مورد کپسول گیاهی مگزا را دریافت می کنند. تصادفی سازی بوسیله جایگشت انجام می شود. کپسول های یک گرمی مگزا 4 بار در روز به مدت 3 ماه به بیمار داده می شود. سپس میزان تحرک، شکل، تعداد اسپرم ها اندازه گیری خواهد شد.
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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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    هدف از انجام این مطالعه: تاثیر ترکیب گیاهی بر هورمونهای جنسی همچنین پرولاکتین در مردان نابارور بوده است.
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    Clinical trial, single-blind and comparative
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    کارآزمایی بالینی ، یک سو کور و مقایسه ای
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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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    این مطالعه طی سالهای۱۳۹۳ -1394 در کلینیک نازایی ام لیلای شهر بندرعباس انجام شد. 50 مرد نابارور 22-42 ساله با معیارهای ورود بطور تصادفی انتخاب شد و 30 نفر در گروه مداخله هر روز دو عدد کپسول 500 میلی گرمی شامل ترکیب گیاهی دریافت میکردند. 20 نفر در گروه کنترل دارونما دو بار در روز، به مدت سه ماه متوالی بصورت هر روز، صبح و شب دریافت کردند. پایان هر هفته از طریق تماس تلفنی مصرف مکمل گیاهی و دارونما در هر دو گروه چک میشد. این پاکت ها حاوی 180 کپسول مکمل گیاهی جهت گروه کنترل و 180 عدد پلاسبو بوده که توسط شرکت گلبدستان، تهیه شده است. بعد از اتمام دوره سه ماهه توانایی معیارهای اسپرم و هورمونهای جنسی و پرولاکتین در گروه مداخله ارزیابی و با قبل از مصرف مکمل گیاهی و گروه کنترل مقایسه شد. شخص جمع اوری کننده اطلاعات و انالیز کننده مطالعه نسبت به کلیه اطلاعات گروه ها و مداخله کاملا کور بوده است.
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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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    معیارهای ورود به مطالعه: مردان نابارور با سن 22 تا 42 سال، تعداد اسپرم کمتر از 20 میلیون در میلی لیتر، موفولولوژی کمتر از 20 درصد، تحرک پیشرونده کمتر از پنجاه درصد معیارهای خروج: واریکوسل، آتروفی بیضه، آزواسپرمی
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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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    گروه مداخله: بیماران علاوه بر دریافت درمان دارویی استاندارد ناباروری توسط پزشک ، هر روز دو عدد کپسول 500 میلی گرمی شامل ترکیب گیاهی عصاره پودر گرده نخل (350 میلیگرم) و عصاره پودرسیاهدانه(250 میلیگرم) صبح و شب را نیز برای مدت سه ماه دریافت کردند. گروه کنترل: بیماران علاوه بر دریافت درمان دارویی استاندارد ناباروری ،هر روز دو عدد کپسول 500 میلی گرمی دارونما صبح و شب را نیز برای مدت سه ماه دریافت کردند.
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    Changes in sperm parameters, sex hormones and prolactin
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    تغییرات در پارامترهای اسپرم، هورمونهای جنسی، پرولاکتین

  • General information

    20
    22
    45
    42
    Not blinded
    Single blinded
    1
    Not used
    Used
    2-3
    3
    50
    62
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    50
    2015-01-21, 1393/11/01
    2015-01-31, 1393/11/11
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    2015-01-31, 1393/11/11
    empty
    2015-06-22, 1394/04/01
    empty
    2015-06-22, 1394/04/01
    empty
    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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    انجام ادیت و اصلاح متد مطالعه. طبق اینکه این اطلاعات مربوط به یک اختراع است هم اکنون باید اطلاعات ان updated شود و به همین دلیل کد اخلاق جدید در شورای کمیته اخلاق دانشگاه دریافت کرد.
    Efficacy of phonix powder capsule on quality of sperm parameters of infertile men
    Evaluating the effect of an herbal complement on sex hormones in infertile men
    تاثیر پودر گرده خرما بر کیفیت پارامترهای اسپرم مردان نابارور
    بررسی هورمونهای جنسی مردان نابارور پس از دریافت مکمل گیاهی: یک مطالعه کارازمایی بالینی یک سو کور
    Clinical trial of efficacy of phonix powder capsule on quality of sperm parameters of infertile men
    The effect of Herbal composition on sex hormones level: a Single-blinded, comparative controlled clinical trial
    کارآزمایی بالینی تاثیر پودر گرده خرما بر کیفیت پارامترهای اسپرم مردان نابارور
    تاثیر ترکیب گیاهی بر سطح هورمون های جنسی: کارازمایی بالینی یک سو کور و مقایسه ای
    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%
    مردان نابارور با سن 22 تا 42 سال
    عدم حساسیت به مصرف گیاهان دارویی
    تعداد اسپرم کمتر از 20 میلیون در میلی لیتر
    موفولولوژی کمتر از 20 درصد
    تحرک پیشرونده کمتر از پنجاه درصد
    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
    سابقه اختلالات ژنتیکی
    ناهنجاری دستگاه تولید مثل
    مواد و داروهای باروری حداقل به مدت شش ماه قبل از شرکت.
    واریکوسل
    آتروفی بیضه
    آزواسپرمی
    اخلال در انزال
    کاندید تزریق داخل سیتوپلاسمی اسپرم
    عدم تمایل بیمار
    ضربه بیضه
    سو مصرف الکل
    سابقه اختلالات سیستمیک
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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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    تصادفی سازی ساده با پاکت مهروموم شده تهیه شده است. در اين روش تعدادي كارت به انتخاب پژوهشگر به عنوان گروه مداخله و همان تعداد كارت براي گروه کنترل در نظر گرفته مي شود؛ سپس با ادغام كردن كارت ها با هم (بر زدن كارت ها) يك كارت خارج شده و تخصيص آن ثبت مي شود و آن كارت پس از خارج شدن مجدداً به جمع ساير كارت ها برگردانده مي شود. سپس كارت ها مجدداً با هم ادغام شده و يك كارت ديگر خارج مي شود. اين روند تا رسيدن به يك توالي تصادفي مطابق با حجم نمونه ادامه مي يابد.
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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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    مسئول جمع آوری داده ها که پیامد را ارزیابی می کند اطلاعی در مورد پاکت های کد بندی و محتویات انها ندارد و نمی داند که گروه مداخله و گروه کنترل چه نوع مداخله ایی را دریافت می کنند.
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  • Ethics committees

    #1
    2015-01-10, 1393/10/20
    2016-03-04, 1394/12/14
    HEC-93-12-4
    IR.HUMS.REC.1394.201

  • Health conditions studied

    #1
    N46
    N46.1
    Male infertility
    Oligospermia

  • Primary outcomes

    #1
    Sperm count
    Sperm Motility
    تعداد اسپرم
    حرکت اسپرم
    3 months after intervention
    Before the intervention and three months after the intervention
    سه ماه پس از شروع مداخله
    قبل از مداخله و سه ماه پس از اتمام مداخله
    Semen analysis
    Determination of sperm motility using CASA computer system
    آزمایش آنالیز اسپرم
    تعیین حرکت اسپرم با استفاده سیستم کامپیوتری کازا
    #2
    Sperm motility
    Sperm count
    تحرک اسپرم
    تعداد اسپرم
    3 months after intervention
    Before the intervention and three months after the intervention
    سه ماه پس از شروع مداخله
    قبل از مداخله و سه ماه پس از اتمام مداخله
    Semen analysis
    Determination of sperm count using CASA computer system
    آزمایش آنالیز اسپرم
    تعیین تعداد اسپرم با استفاده سیستم کامپیوتری کازا
    #3
    Sperm morphology
    The amount of LH
    مورفولوژی اسپرم
    مقدار LH
    3 months after intervention
    Before the intervention and three months after the intervention
    سه ماه پس از شروع مداخله
    قبل از مداخله و سه ماه پس از اتمام مداخله
    Semen analysis
    Measurement of LH by Radioimmunoassay
    آزمایش آنالیز اسپرم
    اندازه گیری LH با روش Radioimmunoassay
    #4
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    The amount of FSH
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    مقدار FSH
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    Before the intervention and three months after the intervention
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    قبل از مداخله و سه ماه پس از اتمام مداخله
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    Measurement of FSH by radioimmunoassay
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    اندازه گیری FSH با روش Radioimmunoassay
    #5
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    The amount of prolactin
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    مقدار پرولاکتین
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    Before the intervention and three months after the intervention
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    قبل از مداخله و سه ماه پس از اتمام مداخله
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    Measurement of prolactin by Radioimmunoassay
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    اندازه گیری پرولاکتین با روش Radioimmunoassay

  • Secondary outcomes

    #1
    Improvement of sperm PH and increase of libido
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    بهبود pH و افزایش میل جنسی
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    3months after intervention
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    سه ماه پس از مداخله
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    Semen Analysis and according to patient
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    آنالیز آنالیز اسپرم و اظهارات بیمار
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  • Intervention groups

    #1
    Intervention of case group: Mogza capsule (1 g): Phoenix dactylifera pollen 0.5 gram; Nigella Satvia seed powder 0.3 gram; Colchicum seed powder 0.1 gram; Alpinia seed powder 0.1 gram.
    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.
    مداخله در گروه بیمار: کپسول یک گرمی گیاهی مگزا شامل نیم گرم گرده نخل خرما؛1 دهم گرم خولنجان؛ 1 دهم گرم سورنجان و 3 دهم گرم سیاهدانه بصورت پودر شده که 4 بار در روز داده می شود.
    گروه مداخله: علاوه بر درمان استاندارد توسط متخصص ارولوژی ، هر روز دو کپسول 500 میلی گرمی حاوی ترکیب 350 میلی گرم پودر عصاره گرده نخل و 250 میلی گرم پودر عصاره سیاهدانه که، یک عدد صبح و یک عدد شب به مدت سه ماه دریافت کردند. هر بیمار در 90 روز 180 کپسول در پاکت بسته بندی شده کد دار دریافت میکرد. کپسول مکمل گیاهی توسط شرکت گلبدستان تهیه شد.
    #2
    Intervention Control: Vitamin E 400 unit per day; L-Carnitine daily
    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.
    مداخله در گروه شاهد: کپسول ویتامینE ، 400 واحد در روز و ال کارنی تین یک بار در روز
    گروه کنترل نیز 180 کپسول، 500 میلی گرمی پلاسبو را با همان رنگ و شکل دارویی گروه مداخله علاوه بر درمان استاندارد برای مدت سه ماه مصرف نمودند. پلاسبو توسط شـركت گلبدسـتان تهیه شد.

  • Recruitment centers

    #1
    Name of recruitment center - English: Fertility and Infertility Research Center of Hormozgan
    Name of recruitment center - Persian: مرکز تحقیقات باروری و ناباروری هرمزگان
    Full name of responsible person - English: Soghra Fallahi
    Full name of responsible person - Persian: صغری فلاحی
    Street address - English: Shahid Naser Boulevard , Shariati Hospital, Fertility and Infertility Research Center of Hormozgan
    Street address - Persian: بلوار شهید ناصر، بیمارستان شریعتی، مرکز تحقیقات باروری و ناباروری هرمزگان
    City - English: Bandar-e Abbas
    City - Persian: بندرعباس
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Umm Leila Fertility and Infertility Clinic
    Name of recruitment center - Persian: کلینیک باروری و ناباروی ام لیلا
    Full name of responsible person - English: Soghra Fallahi
    Full name of responsible person - Persian: صغری فلاحی
    Street address - English: Enghelab St. Infertility Clinic, Umm Leila Hospital, Bandar Abbas,Iran
    Street address - Persian: ایران، بندرعباس، بیمارستان ام لیلا، کلینیک ناباروری، خیابان انقلاب
    City - English: Bandar-e Abbas
    City - Persian: بندرعباس
    Province: Hormozgan
    Country: Iran (Islamic Republic of)
    Postal code: 7915868462
    Phone: +98 76 3333 7192
    Fax: +98 76 3333 7192
    Email: fallahi.leila@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Private
    Name of organization / entity - Persian: خصوصی
    Full name of responsible person - English: Dr Soghra Fallahi
    Full name of responsible person - Persian: دکتر صغری فلاحی
    Street address - English: Jomhouri boulevard, Shahid Mohammadi Hospital, Vice Chancellor for Research of Tabriz University of Medical Sciences, Molecular Medicine Research Center
    Street address - Persian: بلوار جمهوری، بیمارستان شهید محمدی، معاونت تحقیقات و فناوری، مرکز تحقیقات و فناوری، مرکز تحقیقات پزشکی پزشکی مولکولی
    City - English: Bandar-e Abbas
    City - Persian: بندرعباس
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Soghra Fallahi
    Full name of responsible person - Persian: دکتر صغری فلاحی
    Street address - English: Jomhuri Eslami Blvd, Kamarbandi St,Shahid Mohammadi Hospital, Reproduction and Infertility Research Center,Bandar Abbas, Iran
    Street address - Persian: ایران، بندرعباس، بیمارستان شهید محمدی، بلوار جمهوری اسلامی،خیابان کمربندی ،مرکز تحقیقات باروری و ناباروری
    City - English: Bandar-e Abbas
    City - Persian: بندرعباس
    Province: Hormozgan
    Country: Iran (Islamic Republic of)
    Postal code: 7915868462
    Phone: +98 76 3333 7192
    Fax:
    Email: fallahi.leila@gmail.com
    Web page address:
    empty
    Public
    empty
    Domestic
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    Academic
    Private
    Bandare-abbas University of Medical Sciences
    خصوصی
    دانشگاه علوم پزشکی بندرعباس

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Hormozgan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی هرمزگان
    Full name of responsible person - English: Dr Soghra Fallahi
    Full name of responsible person - Persian: دکتر صغری فلاحی
    Position - English: Molecular Medicine PhD Candidate
    Position - Persian: دانشجوی دکترای تخصصی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shahid Naser Boulevard , Shariati Hospital, Fertility and Infertility Research Center of Hormozgan
    Street address - Persian: بلوار شهید ناصر، بیمارستان شریعتی، مرکز تحقیقات باروری و ناباروری هرمزگان
    City - English: Bander-e Abbas
    City - Persian: بندرعباس
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 09173691399
    Phone: +98 76 3333 7192
    Mobile: +98 917 369 1399
    Fax: +98 76 3333 7192
    Email: fallahi.leila@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Soghra Fallahi
    Full name of responsible person - Persian: دکتر صغری فلاحی
    Position - English: PhD in Reproductive Biology
    Position - Persian: دکترای بیولوژی تولید مثل
    Latest degree: phd
    Area of specialty/work: 22
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Fertility/Infertility Research Center, Ring road, Jomhouri Islami Blvd., Shahid Mohammadi Hospital, Bandar Abbas, Iran.
    Street address - Persian: ایران، بندرعباس، بیمارستان شهید محمدی، بلوار جمهوری اسلامی،خیابان کمربندی ،مرکز تحقیقات باروری و ناباروری
    City - English: Bander-e Abbas
    City - Persian: بندرعباس
    Province: Hormozgan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 09173691399
    Phone: +98 76 3333 7192
    Mobile: +98 917 369 1399
    Fax: +98 76 3333 7192
    Email: fallahi.leila@gmail.com
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Hormozgan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی هرمزگان
    Full name of responsible person - English: Dr Soghra Fallahi
    Full name of responsible person - Persian: دکتر صغری فلاحی
    Position - English: Molecular Medicine PhD Candidate
    Position - Persian: دانشجوی دکترای تخصصی پزشکی مولکولی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shahid Naser Boulevard , Shariati Hospital, Fertility and Infertility Research Center of Hormozgan
    Street address - Persian: بلوار شهید ناصر، بیمارستان شریعتی، مرکز تحقیقات باروری و ناباروری هرمزگان
    City - English: Bander-e Abbas
    City - Persian: بنرعباس
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7919915519
    Phone: +98 76 3333 7192
    Mobile: +98 917 369 1399
    Fax: +98 76 3333 7192
    Email: fallahi.leila@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Soghra Fallahi
    Full name of responsible person - Persian: دکتر صغری فلاحی
    Position - English: Reproductive biology PhD student
    Position - Persian: دانشجوی دکترای تخصصی پژوهشی تولید مثل
    Latest degree: phd
    Area of specialty/work: 22
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Fertility and Infertility Research Center, Shahid Mohammadi Hospital, Kamarbandi St, Jomhuri Eslami Blvd, Bandar Abbas, Hormozgan, Iran
    Street address - Persian: ایران، بندرعباس، بیمارستان شهید محمدی، بلوار جمهوری اسلامی،خیابان کمربندی ،مرکز تحقیقات باروری و ناباروری
    City - English: Bander-e Abbas
    City - Persian: بنرعباس
    Province: Hormozgan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7919915519
    Phone: +98 76 3333 7192
    Mobile: +98 917 369 1399
    Fax: +98 76 3333 7192
    Email: fallahi.leila@gmail.com
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Hormozgan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی هرمزگان
    Full name of responsible person - English: Dr Soghra Fallahi
    Full name of responsible person - Persian: دکتر صغری فلاحی
    Position - English: PhD Candidate of Molecular Medicine
    Position - Persian: دانشجوی دکترای تخصصی پژوشی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shahid Naser Boulevard , Shariati Hospital, Fertility and Infertility Research Center of Hormozgan
    Street address - Persian: بلوار شهید ناصر، بیمارستان شریعتی، مرکز تحقیقات باروری و ناباروری هرمزگان
    City - English: Bandar-e Abbas
    City - Persian: بندرعباس
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7919915519
    Phone: +98 76 3333 7192
    Mobile: +98 917 369 1399
    Fax: +98 76 3333 7192
    Email: fallahi.leila@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Soghra Fallahi
    Full name of responsible person - Persian: دکتر صغری فلاحی
    Position - English: Reproductive biology PhD student
    Position - Persian: دانشجوی دکترای تخصصی پژوهشی بیولوژی تولید مثل
    Latest degree: phd
    Area of specialty/work: 22
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Fertility/Infertility Research Center, Ring road, Jomhouri Islami Blvd., Shahid Mohammadi Hospital, Bandar Abbas, Iran.
    Street address - Persian: ایران، بندرعباس، بیمارستان شهید محمدی، بلوار جمهوری اسلامی،خیابان کمربندی ،مرکز تحقیقات باروری و ناباروری
    City - English: Bandar-e Abbas
    City - Persian: بندرعباس
    Province: Hormozgan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7919915519
    Phone: +98 76 3333 7192
    Mobile: +98 917 369 1399
    Fax: +98 76 3333 7192
    Email: fallahi.leila@gmail.com
    Web page address:

  • Sharing plan

    undecided
    no
    no
    no
    no
    no
    no
    empty
    As the present clinical trial is currently patented as a new invention, and now the whole process of commercialization is being completed. Thus in near future we may publish the findings.
    empty
    با توجه به این یک مطالعه بالینی حاضر بصورت اختراع ثبت شده است و در حال حاضر کلیه روند کارهای تجاری سازی ان در حال تکمیل است از این رو در اینده تصمیم بر انتشار نتایج یافته های این مطالعه خواهم داشت.

Protocol summary

Study aim
Objective of this study: The results proved the effectiveness of the herbal composition on sex hormones as well as prolactin in infertile men.
Design
Clinical trial, single-blind and comparative
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
Changes in sperm parameters, sex hormones and prolactin

General information

Reason for update
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
Acronym
IRCT registration information
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
Registration date
2015-11-08, 1394/08/17
Registrant information
Name
Soghra Fallahi
Name of organization / entity
Hormozgan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 76 3333 7192
Email address
lfallahi@hums.ac.ir
Recruitment status
Recruitment complete
Funding source
Hormozgan University of Medical sciences
Expected recruitment start date
2015-01-31, 1393/11/11
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
2015-01-31, 1393/11/11
Actual recruitment end date
2015-06-22, 1394/04/01
Trial completion date
2015-06-22, 1394/04/01
Scientific title
The effect of Herbal composition on sex hormones level: a Single-blinded, comparative controlled clinical trial
Public title
Evaluating the effect of an herbal complement on sex hormones in infertile men
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 22 years old to 42 years old
Gender
Male
Phase
3
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 62
Actual sample size reached: 50
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Single blinded
Blinding description
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethis ommittee of Bandar Abbas University of Medical Sciences
Street address
Fertility and infertility researh enter,Shahid Mohammadi Hospital,Kamarbandi st., Jomhuri Eslami Blvd., Bandar Abbas, Hormozgan,Iran.
City
Bandar Abbas
Province
Hormozgan
Postal code
7919915519
Approval date
2016-03-04, 1394/12/14
Ethics committee reference number
IR.HUMS.REC.1394.201

Health conditions studied

1

Description of health condition studied
Male infertility
ICD-10 code
N46.1
ICD-10 code description
Oligospermia

Primary outcomes

1

Description
Sperm Motility
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Determination of sperm motility using CASA computer system

2

Description
Sperm count
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Determination of sperm count using CASA computer system

3

Description
The amount of LH
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Measurement of LH by Radioimmunoassay

4

Description
The amount of FSH
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Measurement of FSH by radioimmunoassay

5

Description
The amount of prolactin
Timepoint
Before the intervention and three months after the intervention
Method of measurement
Measurement of prolactin by Radioimmunoassay

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Treatment - Drugs

2

Description
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.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Umm Leila Fertility and Infertility Clinic
Full name of responsible person
Soghra Fallahi
Street address
Enghelab St. Infertility Clinic, Umm Leila Hospital, Bandar Abbas,Iran
City
Bandar-e Abbas
Province
Hormozgan
Postal code
7915868462
Phone
+98 76 3333 7192
Fax
+98 76 3333 7192
Email
fallahi.leila@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr Soghra Fallahi
Street address
Jomhuri Eslami Blvd, Kamarbandi St,Shahid Mohammadi Hospital, Reproduction and Infertility Research Center,Bandar Abbas, Iran
City
Bandar-e Abbas
Province
Hormozgan
Postal code
7915868462
Phone
+98 76 3333 7192
Email
fallahi.leila@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandare-abbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr Soghra Fallahi
Position
PhD in Reproductive Biology
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Fertility/Infertility Research Center, Ring road, Jomhouri Islami Blvd., Shahid Mohammadi Hospital, Bandar Abbas, Iran.
City
Bander-e Abbas
Province
Hormozgan
Postal code
09173691399
Phone
+98 76 3333 7192
Fax
+98 76 3333 7192
Email
fallahi.leila@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr Soghra Fallahi
Position
Reproductive biology PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Fertility and Infertility Research Center, Shahid Mohammadi Hospital, Kamarbandi St, Jomhuri Eslami Blvd, Bandar Abbas, Hormozgan, Iran
City
Bander-e Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3333 7192
Fax
+98 76 3333 7192
Email
fallahi.leila@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr Soghra Fallahi
Position
Reproductive biology PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Fertility/Infertility Research Center, Ring road, Jomhouri Islami Blvd., Shahid Mohammadi Hospital, Bandar Abbas, Iran.
City
Bandar-e Abbas
Province
Hormozgan
Postal code
7919915519
Phone
+98 76 3333 7192
Fax
+98 76 3333 7192
Email
fallahi.leila@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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