Herbal Tonic Fertile Supplement(ZO2C5) ((ZO2C5))
Primary Purpose
Male Infertility
Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
coated tablet
Sponsored by
About this trial
This is an interventional supportive care trial for Male Infertility focused on measuring male infertility,oligo spermia
Eligibility Criteria
Inclusion Criteria:
- all patients suffering from oligospermia are included
Exclusion Criteria:
- any diseases
Sites / Locations
- Womens Reproductive Health Research Center,Tabriz University Of Medical Sciences,Iran
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
fertility coated tablet
Arm Description
700 mg fertility coated tablet containing 8 herbal powders by mouth every 12 hours for 180 days
Outcomes
Primary Outcome Measures
Sperm count variation
Semen analysis according WHO methods
Secondary Outcome Measures
Sperm motility
Semen analysis
Sperm Viability
Semen analysis
Full Information
NCT ID
NCT01895816
First Posted
September 12, 2012
Last Updated
July 11, 2013
Sponsor
Arash Khaki
Collaborators
Islamic Azad University of Tabriz, Tabriz University
1. Study Identification
Unique Protocol Identification Number
NCT01895816
Brief Title
Herbal Tonic Fertile Supplement(ZO2C5)
Acronym
(ZO2C5)
Official Title
Phase 3 of Study on Effects of New Herbal Mixture on Men Infertility
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Arash Khaki
Collaborators
Islamic Azad University of Tabriz, Tabriz University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility
Keywords
male infertility,oligo spermia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Care Provider
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fertility coated tablet
Arm Type
Experimental
Arm Description
700 mg fertility coated tablet containing 8 herbal powders by mouth every 12 hours for 180 days
Intervention Type
Dietary Supplement
Intervention Name(s)
coated tablet
Other Intervention Name(s)
Dietry supplement
Intervention Description
this supplement contains 700 mg of 8 natural herbals: Citrus & ZINGIBER OFFICINALE & Onion & Ocimum basilicum & Cinnamomum zelanicum & Citrullus lanatus & Citrullus vulgaris & Daucus carota
Primary Outcome Measure Information:
Title
Sperm count variation
Description
Semen analysis according WHO methods
Time Frame
First day of research, 2th time for sampling is 180 days after treatment
Secondary Outcome Measure Information:
Title
Sperm motility
Description
Semen analysis
Time Frame
1th time in first day of research, 2th time after 180 days of treatment
Title
Sperm Viability
Description
Semen analysis
Time Frame
1th time in first day of research, 2th time after 180 days of treatment
Other Pre-specified Outcome Measures:
Title
Testosterone levels
Description
Testosterone analysis
Time Frame
1th time in first day of research, 2th time after 180 days of treatment
Title
Serum Total antioxidant levels
Description
Total antioxidant measurement in serum
Time Frame
1th time in first day of research, 2th time after 180 days of treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
all patients suffering from oligospermia are included
Exclusion Criteria:
any diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arash Khaki, PhD
Organizational Affiliation
Women Reproductive Health Research Center,Tabriz University of medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Womens Reproductive Health Research Center,Tabriz University Of Medical Sciences,Iran
City
Tabriz
State/Province
Azarbyjan
ZIP/Postal Code
51388
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
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Herbal Tonic Fertile Supplement(ZO2C5)
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