Herbal Tonic Fertile Supplement(ZO2C5) | NCT01895816

Studies
Herbal Tonic Fertile Supplement(ZO2C5)

NCT01895816

Sponsor

Arash Khaki

Status

Completed

Last Update Posted

Jul 12, 2013Estimated

Enrollment

1Actual

Phase

Phase 3

Conditions

Male Infertility

Interventions

coated tablet

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Sep 12, 2012

First Submission Date that Met QC Criteria

Jul 7, 2013

First Posted Date

Jul 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2013

Last Update Posted Date

Jul 12, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Arash Khaki, Clinical professor. Women's Reproductive Health Research Center, Tabriz University of Medical Sciences, Tabriz, Iran., Islamic Azad University of TabrizSponsor-Investigator

Lead Sponsor

Arash KhakiOTHER

Collaborators

Name	Class
Islamic Azad University of Tabriz	OTHER
Tabriz University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
fertility coated tablet	Experimental	700 mg fertility coated tablet containing 8 herbal powders by mouth every 12 hours for 180 days	Dietary Supplement: coated tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
coated tablet	Dietary Supplement	this supplement contains 700 mg of 8 natural herbals: Citrus & ZINGIBER OFFICINALE & Onion & Ocimum basilicum & Cinnamomum zelanicum & Citrullus lanatus & Citrullus vulgaris & Daucus carota

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all patients suffering from oligospermia are included

Exclusion Criteria:

any diseases

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arash Khaki, PhD	Women Reproductive Health Research Center,Tabriz University of medical Sciences	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Womens Reproductive Health Research Center,Tabriz University Of Medical Sciences,Iran		Tabriz	Azarbyjan	51388	Iran

Condition Browse Module

MeSH Terms

ID	Term
D007248	Infertility, Male

Ancestor Terms

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007246	Infertility

Browse Leaves

Not provided

Browse Branches

Not provided