Clinical trial NCT01895816: Herbal Tonic Fertile Supplement(ZO2C5)
Official title: Phase 3 of Study on Effects of New Herbal Mixture on Men Infertility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Male Infertility
Keywords: male infertility,oligo spermia
Lead sponsor: Islamic Azad University of Tabriz
Sponsor class: OTHER
Collaborators: name: Islamic Azad University of Tabriz
name: Tabriz University
First posted: 2013-07-11
Enrollment: 1
Sex: MALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* all patients suffering from oligospermia are included

Exclusion Criteria:

* any diseases

Primary outcomes:
measure: Sperm count variation
timeFrame: First day of research, 2th time for sampling is 180 days after treatment
Secondary outcomes:
measure: Sperm motility
timeFrame: 1th time in first day of research, 2th time after 180 days of treatment
measure: Sperm Viability
timeFrame: 1th time in first day of research, 2th time after 180 days of treatment
Other outcomes:
measure: Testosterone levels
timeFrame: 1th time in first day of research, 2th time after 180 days of treatment
measure: Serum Total antioxidant levels
timeFrame: 1th time in first day of research, 2th time after 180 days of treatment
Locations:
city: Tabriz
country: Iran, Islamic Republic of
facility: Womens Reproductive Health Research Center,Tabriz University Of Medical Sciences,Iran
state: Azarbyjan
Study officials:
affiliation: Women Reproductive Health Research Center,Tabriz University of medical Sciences
name: Arash Khaki, PhD
role: STUDY_DIRECTOR
References: