Herbal Tonic Fertile Supplement(ZO2C5)

This study has been completed.
Sponsor:
Collaborators:
Islamic Azad University of Tabriz
Tabriz University
Information provided by (Responsible Party):
Arash Khaki, Islamic Azad University of Tabriz
ClinicalTrials.gov Identifier:
NCT01895816
First received: September 12, 2012
Last updated: July 11, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Male Infertility
Dietary Supplement: coated tablet
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Supportive Care
Official Title: Phase 3 of Study on Effects of New Herbal Mixture on Men Infertility

Resource links provided by NLM:


Further study details as provided by Islamic Azad University of Tabriz:

Primary Outcome Measures:
  • Sperm count variation [ Time Frame: First day of research, 2th time for sampling is 180 days after treatment ] [ Designated as safety issue: Yes ]
    Semen analysis according WHO methods


Secondary Outcome Measures:
  • Sperm motility [ Time Frame: 1th time in first day of research, 2th time after 180 days of treatment ] [ Designated as safety issue: Yes ]
    Semen analysis

  • Sperm Viability [ Time Frame: 1th time in first day of research, 2th time after 180 days of treatment ] [ Designated as safety issue: Yes ]
    Semen analysis


Other Outcome Measures:
  • Testosterone levels [ Time Frame: 1th time in first day of research, 2th time after 180 days of treatment ] [ Designated as safety issue: Yes ]
    Testosterone analysis

  • Serum Total antioxidant levels [ Time Frame: 1th time in first day of research, 2th time after 180 days of treatment ] [ Designated as safety issue: Yes ]
    Total antioxidant measurement in serum


Enrollment: 1
Study Start Date: June 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fertility coated tablet
700 mg fertility coated tablet containing 8 herbal powders by mouth every 12 hours for 180 days
Dietary Supplement: coated tablet
this supplement contains 700 mg of 8 natural herbals: Citrus & ZINGIBER OFFICINALE & Onion & Ocimum basilicum & Cinnamomum zelanicum & Citrullus lanatus & Citrullus vulgaris & Daucus carota
Other Name: Dietry supplement

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

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • all patients suffering from oligospermia are included

Exclusion Criteria:

  • any diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01895816

Locations
Iran, Islamic Republic of
Womens Reproductive Health Research Center,Tabriz University Of Medical Sciences,Iran
Tabriz, Azarbyjan, Iran, Islamic Republic of, 51388
Sponsors and Collaborators
Arash Khaki
Islamic Azad University of Tabriz
Tabriz University
Investigators
Study Director: Arash Khaki, PhD Women Reproductive Health Research Center,Tabriz University of medical Sciences
  More Information

No publications provided

Responsible Party: Arash Khaki, Clinical professor. Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran., Islamic Azad University of Tabriz
ClinicalTrials.gov Identifier: NCT01895816     History of Changes
Other Study ID Numbers: WRHRC-9026
Study First Received: September 12, 2012
Last Updated: July 11, 2013
Health Authority: Iran: Ministry of Health

Keywords provided by Islamic Azad University of Tabriz:
male infertility,oligo spermia

Additional relevant MeSH terms:
Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 28, 2014