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Completed

NCT Number: NCT01895816

Herbal Tonic Fertile Supplement(ZO2C5)

The purpose of this study is to determine whether the effect of mixed herbals drug (citrus, citrolus vol, lan, carrot seed, zingiber, onion, basil, cinnamon) administration on male infertility: oligospermia

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Key information

Age range

25 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Womens Reproductive Health Research Center,Tabriz University Of Medical Sciences,Iran

Tabriz, Azarbyjan, 51388, Iran

About this study

In the last few years, a marked decrease in the quality of semen has been reported. Infertility is one of the major health problems in 10 to 15% of couples' lives; from which approximately 50% of couple's infertility is due to Male factors. The aim of the present study was to evaluate an herbal mixed effects on spermatogenesis and the normal production of sperm. Researchers have reported that using antioxidants and vitamins A, B, C, E, flavonoids, Sulfur compounds, terpenoids and phenolic compounds in the daily diet can protect sperm. In this study the investigators aimed to assess synergistic effect of these herbal compounds in male Infertility. 700 mg tablet for 180 consequence days/daily will be advising, for 40 patients semen samples in 1th and 180 day after treatment will take, in andrology lab according WHO method:samples put into 2 mL of medium (Hams F10) containing 0.5% bovine serum albumin. After 5 min incubation at 37oC (with 5% CO), the sperm samples were determined using the standard haemocytometric method, and sperm motility was analyzed by microscope (Olympus IX70) at 10 field and reported as the mean of motile sperm according to WHO methods . The sperm abnormality was evaluated according to the standard method of Narayana .Briefly, smears of the sperm suspension were made on clean glass slides and stained with periodic acid-Schiff's reaction haematoxylin. The stained smears were observed under a light microscopic with 40× magnification. The sperms were classified into normal and abnormal. The total sperm abnormality was expressed as percentage incidence. Other biochemical tests will be doing according the our research protocol and thesis for blood samples for measure LH, Testosterone, TAC, Glc and Cholesterol.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all patients suffering from oligospermia are included

Exclusion criteria

  • any diseases

Treatment and study plan

coated tablet

Dietary Supplement

this supplement contains 700 mg of 8 natural herbals: Citrus & ZINGIBER OFFICINALE & Onion & Ocimum basilicum & Cinnamomum zelanicum & Citrullus lanatus & Citrullus vulgaris & Daucus carota

Other names: Dietry supplement

Primary outcomes

  1. Sperm count variation

    Time frame: First day of research, 2th time for sampling is 180 days after treatment

    Semen analysis according WHO methods

Secondary outcomes

  1. Sperm motility

    Time frame: 1th time in first day of research, 2th time after 180 days of treatment

    Semen analysis

  2. Sperm Viability

    Time frame: 1th time in first day of research, 2th time after 180 days of treatment

    Semen analysis

Other outcomes

  1. Testosterone levels

    Time frame: 1th time in first day of research, 2th time after 180 days of treatment

    Testosterone analysis

  2. Serum Total antioxidant levels

    Time frame: 1th time in first day of research, 2th time after 180 days of treatment

    Total antioxidant measurement in serum

Sponsors and collaborators

Lead sponsor

Arash Khaki

Other

Collaborators

  • Islamic Azad University of Tabriz
  • Tabriz University

Registry information

Official study title

Phase 3 of Study on Effects of New Herbal Mixture on Men Infertility

Acronym: (ZO2C5)

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 11, 2013
Registry last updated
Jul 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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