Herbal Tonic Fertile Supplement(ZO2C5)

Male Infertility Clinical Trial

— (ZO2C5)  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895816
• Other study ID #: WRHRC-9026
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2012
• Last updated: July 11, 2013
• Start date: June 2012
• Est. completion date: June 2012

Study information

• Verified date: July 2013
• Source: Islamic Azad University of Tabriz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 50 Years

Eligibility

Inclusion Criteria:

• all patients suffering from oligospermia are included

Exclusion Criteria:

• any diseases

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Womens Reproductive Health Research Center,Tabriz University Of Medical Sciences,Iran	Tabriz	Azarbyjan

Sponsors (3)

Lead Sponsor	Collaborator
Arash Khaki	Islamic Azad University of Tabriz, Tabriz University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Testosterone levels	Testosterone analysis	1th time in first day of research, 2th time after 180 days of treatment	Yes
Other	Serum Total antioxidant levels	Total antioxidant measurement in serum	1th time in first day of research, 2th time after 180 days of treatment	Yes
Primary	Sperm count variation	Semen analysis according WHO methods	First day of research, 2th time for sampling is 180 days after treatment	Yes
Secondary	Sperm motility	Semen analysis	1th time in first day of research, 2th time after 180 days of treatment	Yes
Secondary	Sperm Viability	Semen analysis	1th time in first day of research, 2th time after 180 days of treatment	Yes