Herbal Tonic Fertile Supplement(ZO2C5) ((ZO2C5))

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

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

Study Overview

• Status: Completed
• Conditions: Male Infertility
• Intervention / Treatment: Dietary supplement: coated tablet

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Azarbyjan
    • Tabriz, Azarbyjan, Iran, Islamic Republic of, 51388
      • Womens Reproductive Health Research Center,Tabriz University Of Medical Sciences,Iran

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• all patients suffering from oligospermia are included

Exclusion Criteria:

• any diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Dietry supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sperm count variation	Semen analysis according WHO methods	First day of research, 2th time for sampling is 180 days after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sperm motility	Semen analysis	1th time in first day of research, 2th time after 180 days of treatment
Sperm Viability	Semen analysis	1th time in first day of research, 2th time after 180 days of treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Testosterone levels	Testosterone analysis	1th time in first day of research, 2th time after 180 days of treatment
Serum Total antioxidant levels	Total antioxidant measurement in serum	1th time in first day of research, 2th time after 180 days of treatment

Collaborators and Investigators

• Sponsor: Arash Khaki
• Collaborators: Tabriz University; Islamic Azad University of Tabriz
• Investigators: Study Director: Arash Khaki, PhD, Women Reproductive Health Research Center,Tabriz University of medical Sciences

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: September 12, 2012
• First Submitted That Met QC Criteria: July 7, 2013
• First Posted (Estimate): July 11, 2013

Study Record Updates

• Last Update Posted (Estimate): July 12, 2013
• Last Update Submitted That Met QC Criteria: July 11, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: male infertility,oligo spermia
• Additional Relevant MeSH Terms: Infertility; Infertility, Male
• Other Study ID Numbers: WRHRC-9026