Male InfertilityPhase 3(ZO2C5)NCT01895816
Herbal Tonic Fertile Supplement(ZO2C5)
A Phase 3 study testing coated tablet in people with Male Infertility, run by Arash Khaki at 1 site in Iran.
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 Read more about this study
- Who is it for?
- Ages 25 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Infertility
- What is being tested?
- coated tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteIran
- Study dates
- Jun 2012to Jun 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- all patients suffering from oligospermia are included
Who cannot join
- any diseases
Trial locations and contacts
1 site in 1 country.
Iran1 site
Womens Reproductive Health Research Center,Tabriz University Of Medical Sciences,Iran
Tabriz, Azarbyjan, 51388
About this study
Official title: 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
Read the 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.
- Conditions
- Male Infertility
- Being tested
- coated tablet
- Keywords
- male infertility,oligo spermia
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coated tabletDietary supplement
Also called Dietry supplement
this supplement contains 700 mg of 8 natural herbals: Citrus \& ZINGIBER OFFICINALE \& Onion \& Ocimum basilicum \& Cinnamomum zelanicum \& Citrullus lanatus \& Citrullus vulgaris \& Daucus carota
| Study group | Role | What they receive |
|---|---|---|
| fertility coated tablet | Experimental | 700 mg fertility coated tablet containing 8 herbal powders by mouth every 12 hours for 180 days Receives: Dietary Supplement: coated tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm count variation
Semen analysis according WHO methods
Measured: First day of research, 2th time for sampling is 180 days after treatment
Secondary outcomes (2)
Sperm motility
Semen analysis
Measured: 1th time in first day of research, 2th time after 180 days of treatment
Sperm Viability
Semen analysis
Measured: 1th time in first day of research, 2th time after 180 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startJun 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arash Khaki
- Sponsor type
- University, hospital or other
- Collaborators
- Islamic Azad University of Tabriz, Tabriz University
- Responsible party
- Sponsor-investigator, Arash Khaki, Islamic Azad University of Tabriz
- Investigators
- Arash Khaki, PhD, Study director, Women Reproductive Health Research Center,Tabriz University of medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895816
- Sponsor's protocol ID
- WRHRC-9026
- Acronym
- (ZO2C5)
- Status last verified
- Jul 2013
- First submitted
- 12 Sep 2012
- Last updated
- 12 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 of Study on Effects of New Herbal Mixture on Men Infertility
- ClinicalTrials.gov ID
- NCT01895816
- Acronym / sponsor ID
- (ZO2C5) / WRHRC-9026
- Conditions
- Male Infertility
- Keywords
- male infertility,oligo spermia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Arash KhakiUniversity, hospital or other
- Collaborators
- Islamic Azad University of Tabriz, Tabriz University
- Study start
- Jun 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fertility coated tablet | Experimental | Dietary Supplement: coated tablet700 mg fertility coated tablet containing 8 herbal powders by mouth every 12 hours for 180 days |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all patients suffering from oligospermia are included
Key exclusion criteria (1 listed)
- any diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coated tabletAlso: Dietry supplementthis supplement contains 700 mg of 8 natural herbals: Citrus \& ZINGIBER OFFICINALE \& Onion \& Ocimum basilicum \& Cinnamomum zelanicum \& Citrullus lanatus \& Citrullus vulgaris \& Daucus carota | Dietary supplement | fertility coated tablet |
Primary outcome
Sperm count variation
Time frame: First day of research, 2th time for sampling is 180 days after treatment
Semen analysis according WHO methods
2 secondary outcomes
Sperm motility
Time frame: 1th time in first day of research, 2th time after 180 days of treatment
Sperm Viability
Time frame: 1th time in first day of research, 2th time after 180 days of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arash Khaki, PhD study director
Women Reproductive Health Research Center,Tabriz University of medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing coated tablet in people with Male Infertility, run by Arash Khaki at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperm count variation (time frame: First day of research, 2th time for sampling is 180 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2013.