Herbal Tonic Fertile Supplement(ZO2C5)

Phase 3

Completed

• Conditions: Male Infertility
• Interventions: Dietary Supplement: coated tablet

• Registration Number: NCT01895816
• Lead Sponsor: Arash Khaki

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.

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted: 2012-09-12
• Status Verified: 2013-07
• Study First Submitted QC: 2013-07-07
• Study First Posted: 2013-07-11
• Last Update Submitted: 2013-07-11
• Last Update Posted: 2013-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1

Inclusion Criteria

• all patients suffering from oligospermia are included

Exclusion Criteria

• any diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
fertility coated tablet	coated tablet	700 mg fertility coated tablet containing 8 herbal powders by mouth every 12 hours for 180 days

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Sperm motility	1th time in first day of research, 2th time after 180 days of treatment	Semen analysis
Sperm Viability	1th time in first day of research, 2th time after 180 days of treatment	Semen analysis

Trial Locations

Locations (1)

Womens Reproductive Health Research Center,Tabriz University Of Medical Sciences,Iran; 🇮🇷 Tabriz, Azarbyjan, Iran, Islamic Republic of