Intrauterine Growth Restriction (IUGR)Phase 2NCT02425436
Role of Ginkgo Biloba Extract in IUGR
A Phase 2 study testing Ginkgo Biloba Extract in people with Intrauterine Growth Restriction (IUGR), run by Assiut University.
Trial summary
The use of herbal medicinal products is increasing enormously in recent years, mainly among women, who use them for the most varied purposes, such as in menstrual problems, menopausal symptoms, mood disturbances and to strengthen their bones. Most of these benefits are due to the flavonoids present in these products. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Intrauterine Growth Restriction (IUGR)
- What is being tested?
- Ginkgo Biloba Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 226 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Dec 2015
- Phase
- Phase 2
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women in their third trimester (28-30 weeks of gestation).
- Pregnant women whose pregnancy was complicated with intra uterine growth restriction (IUGR).
- Normal Doppler indices in uterine, umbilical and middle cerebral arteries at time of recruitment.
Who cannot join
- Multiple pregnancies,
- Hypertension,
- Fetal congenital anomalies,
- Previous history of congenital anomalies or chromosomal abnormalities.
- Diabetes Mellitus
- Premature pre-labor rupture of membranes
- Antepartum hemorrhage
About this study
Official title: Effects of Oral Ginkgo Biloba Extract on Pregnancy Complicated by Asymmetrically Intrauterine Growth Restriction: a Double-blinded Randomized Placebo-controlled Trial
The use of herbal medicinal products is increasing enormously in recent years, mainly among women, who use them for the most varied purposes, such as in menstrual problems, menopausal symptoms, mood disturbances and to strengthen their bones. Most of these benefits are due to the flavonoids present in these products. These flavonoids have anticarcinogenic, antiviral, antioxidant and antiinflammatory activities, as well as being used in the treatment of osteoporosis, menopausal symptoms and cardiovascular diseases . Besides the benefits from the consumption of flavonoids, little is known about their safety and potentially harmful toxic effects, such as mutagenicity and genotoxicity which might occur if taken in large doses . Safety of Ginkgo biloba during pregnancy or lactation was not criticized in literature. Roasted and raw ginkgo seed were not reported in the evidence-based medicine literature as being either safe or contraindicated in pregnancy or lactation. A higher incidence of postpartum hemorrhage was reported in the literature when associated with a 3-month ingestion of Ginkgo Biloba extract. Flavonoids are components of Ginkgo biloba L. (Ginkgoaceae), a medicinal plant widely used by the population . G. biloba has its origin in China, Korea and Japan where its fruits and leaves have been used as food and medicine for a long time.
The extract of G. biloba (EGb) is composed of different terpene trilactones, i.e., ginkgolides A, B, C, J and bilobalide, many flavonol glycosides, biflavones and alkylphenols . The major flavonoids in the extract are kaempferol, quercetin and isorhamnetin] whose metabolites were found in the blood of rats and in human urine after oral administration of EGb. Due to its actions as an anti-inflammatory and antioxidant, EGb has been largely used in the treatment of Alzheimer's disease, pre-menstrual syndrome, cerebrovascular insufficiency and peripheral arterial occlusive disease . In folk medicine, EGb is used as a vermifuge, to induce labor, for the treatment of bronchitis, chronic rhinitis, chilblains, arthritis and edema . The aim of this study was to evaluate the effect of oral supplementation of Ginkgo Biloba extract on the fetal weight as well as feto-maternal blood flow in cases of intrauterine growth restriction.
- Conditions
- Intrauterine Growth Restriction (IUGR)
- Being tested
- Ginkgo Biloba Extract, Placebo
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginkgo Biloba ExtractDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Ginkgo Biloba Extract group | Active comparator | This group received Ginko Biloba, two tablets per day Receives: Drug: Ginkgo Biloba Extract |
| Placebo group | Placebo comparator | This group received placebo two tablets per day . Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal weight (gm)
Measured: one and half year
Secondary outcomes (3)
Doppler blood flow changes in uterine arteries indices
Measured: one and half year
Doppler blood flow changes in umbilical arteries indices
Measured: one and half year
Doppler blood flow changes in middle cerebral artery indices
Measured: one and half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2015 (estimated)
- Study startMay 2014
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine Growth Restriction (IUGR)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamad sayed abdellah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425436
- Sponsor's protocol ID
- Tibonina/ IUGR
- Status last verified
- Mar 2016
- First submitted
- 21 Apr 2015
- Last updated
- 22 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Ginkgo Biloba Extract on Pregnancy Complicated by Asymmetrically Intrauterine Growth Restriction: a Double-blinded Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02425436
- Acronym / sponsor ID
- Tibonina/ IUGR
- Conditions
- Intrauterine Growth Restriction (IUGR)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Apr 2015 (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 use of herbal medicinal products is increasing enormously in recent years, mainly among women, who use them for the most varied purposes, such as in menstrual problems, menopausal symptoms, mood disturbances and to strengthen their bones. Most of these benefits are due to the flavonoids present in these products. These flavonoids have anticarcinogenic, antiviral, antioxidant and antiinflammatory activities, as well as being used in the treatment of osteoporosis, menopausal symptoms and cardiovascular diseases . Besides the benefits from the consumption of flavonoids, little is known about their safety and potentially harmful toxic effects, such as mutagenicity and genotoxicity which might occur if taken in large doses . Safety of Ginkgo biloba during pregnancy or lactation was not criticized in literature. Roasted and raw ginkgo seed were not reported in the evidence-based medicine literature as being either safe or contraindicated in pregnancy or lactation. A higher incidence of postpartum hemorrhage was reported in the literature when associated with a 3-month ingestion of Ginkgo Biloba extract. Flavonoids are components of Ginkgo biloba L. (Ginkgoaceae), a medicinal plant widely used by the population . G. biloba has its origin in China, Korea and Japan where its fruits and leaves have been used as food and medicine for a long time.
The extract of G. biloba (EGb) is composed of different terpene trilactones, i.e., ginkgolides A, B, C, J and bilobalide, many flavonol glycosides, biflavones and alkylphenols . The major flavonoids in the extract are kaempferol, quercetin and isorhamnetin] whose metabolites were found in the blood of rats and in human urine after oral administration of EGb. Due to its actions as an anti-inflammatory and antioxidant, EGb has been largely used in the treatment of Alzheimer's disease, pre-menstrual syndrome, cerebrovascular insufficiency and peripheral arterial occlusive disease . In folk medicine, EGb is used as a vermifuge, to induce labor, for the treatment of bronchitis, chronic rhinitis, chilblains, arthritis and edema . The aim of this study was to evaluate the effect of oral supplementation of Ginkgo Biloba extract on the fetal weight as well as feto-maternal blood flow in cases of intrauterine growth restriction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ginkgo Biloba Extract group | Active comparator | Drug: Ginkgo Biloba ExtractThis group received Ginko Biloba, two tablets per day |
| Placebo group | Placebo comparator | Other: PlaceboThis group received placebo two tablets per day . |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women in their third trimester (28-30 weeks of gestation).
- Pregnant women whose pregnancy was complicated with intra uterine growth restriction (IUGR).
- Normal Doppler indices in uterine, umbilical and middle cerebral arteries at time of recruitment.
Key exclusion criteria (7 listed)
- Multiple pregnancies,
- Hypertension,
- Fetal congenital anomalies,
- Previous history of congenital anomalies or chromosomal abnormalities.
- Diabetes Mellitus
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 |
|---|---|---|
| Ginkgo Biloba Extract | Drug | Ginkgo Biloba Extract group |
| Placebo | Other | Placebo group |
Primary outcome
Fetal weight (gm)
Time frame: one and half year
3 secondary outcomes
Doppler blood flow changes in uterine arteries indices
Time frame: one and half year
Doppler blood flow changes in umbilical arteries indices
Time frame: one and half year
Doppler blood flow changes in middle cerebral artery indices
Time frame: one and half year
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 22 Mar 2016.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ginkgo Biloba Extract in people with Intrauterine Growth Restriction (IUGR), run by Assiut University.
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 3 inclusion and 7 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 22 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Fetal weight (gm) (time frame: one and half year). 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 22 Mar 2016.