AnemiaPhase 2NCT01670955
The Safety and Effectiveness of Jobelyn in Pre-operative Management of Anaemia in Gynaecological Patients
A Phase 2 study testing Jobelyn and Ferrous Sulphate + Folic Acid in people with Anemia, run by Lagos State University at 1 site in Nigeria.
Trial summary
PROTOCOL FOR THE STUDY OF THE SAFETY AND EFFICACY OF JOBELYN, IN THE PREOPERATIVE MANAGEMENT OF ANAEMIA IN GYNAECOLOGICAL PATIENTS Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- Jobelyn and Ferrous Sulphate + Folic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteNigeria
- Study dates
- Dec 2012to Dec 2013
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mild to moderate anaemia
- Asymptomatic severe anaemia
- Non life threatening gynaecological condition
Who cannot join
- Failure to give informed consent
- Symptomatic severe anaemia
- Pregnancy
- Malignancies and Chronic inflammatory disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Phase II/III Randomized, Blinded Study to Demonstrate the Safety and Effectiveness of Jobelyn ( a Herbal Preparation ) in Pre-operative Management of Anaemia in Gynaecological Patients
PROTOCOL FOR THE STUDY OF THE SAFETY AND EFFICACY OF JOBELYN, IN THE PREOPERATIVE MANAGEMENT OF ANAEMIA IN GYNAECOLOGICAL PATIENTS
Read the detailed description
It has long been known that anaemia increases the risk of death and complications in patients who have cardiovascular surgery, but results of a recent study show that these risks are increased in patients with anaemia who undergo various types of surgery, including gynaecological procedures.
Compared with patients without anaemia, the risk of death within 30 days after surgery was 42% higher among patients with anaemia. In addition, patients with anemia were 35% more likely to experience cardiac, respiratory, urinary, and wound complications as well as sepsis and blood clots.
Because even mild anaemia increases the risk of postoperative morbidity in patients undergoing major non-cardiac surgery, doctors need to consider preoperative treatment of anaemia when possible. More research is needed to establish the efficacy, safety and cost-effectiveness of pre-operative anaemia management.
One of the major clinical issues in many gynaecological patients in Nigeria is that of optimizing the packed cell volume before surgery. Anaemia could be traced to multiple factors notable of which are high prevalence of infection, worm infestation and malnutrition (R). In other to reduce the waiting time and reduce morbidity and mortality associated with surgery, it is important to correct the packed cell volume adequately before surgery.
The traditional method of correcting PCV involves the use of 'routine' haematinics such as Ferrous sulphate, Folic acid and Multivitamin. This is in addition to dietary advice. While the efficacy of these drugs has been well acknowledged in clinical practice, there is dearth of literatures on their specific influence on haematological parameters. Majority of Nigerians are gradually having a change of perception about traditional medicines with gradual shift towards their use. It is believed that traditional drugs act faster and more effective than other orthodox drugs in conventional use. One of such area is in the correction of anaemia.
Sorghum bicolor, a grain long used in Africa for its high nutritional value also exhibits strong antioxidant properties and antiinflammatory effects. The traditional preparation of Sorghum bicolor has an oxygen radical absorbance capacity (ORAC) OF 37,622 micro mole TE/g. This is much higher than other botanical preparations. Complementing the antioxidant properties, Sorghum bicolor also exhibits anti inflammatory effects and demonstrated selective COX-2 inhibition, providing effective reduction in inflammation without residual side effects.
Sorghum bicolor extract has been shown to increase the haematocrit and haemoglobin level and reduce the white cell count in trypanosome brucei brucei induced anaemia in experimental rabbits. These effects were conclusive within 49 days of experimentation. Animals sacrificed after the administration of lethal dose Jobelyn were shown to have congestion of the liver, kidneys and lungs. This might be as a result of direct effect on these organs or a sign of cardiotoxicity. However there is a wide therapeutic range.
Sorghum bicolor is the proprietary name for the product intended to treat sickle cell disease. It is exactly the same as jobelyn which is currently marketed as a nutritional supplement. Jobelyn is marketed in 250mg capsules of sorghum bicolor leaf extract. The product is widely marketed in the United States and in Nigeria. Many pregnant women have been using it regularly for a long time without any report of adverse effect.
The sorghum bicolor extract is expected to increase the haematocrit of' pregnant women within a short time.
- Conditions
- Anemia
- Being tested
- Jobelyn, Ferrous Sulphate + Folic Acid
- Keywords
- Anemia, preoperative, gynecological patients, Sorghum bicolor, Packed Cells Volume
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JobelynDietary supplement
Also called Sorghum bicolor extract
Jobelyn is a sorghum bicolor extract marketed as dietary supplement
Ferrous Sulphate + Folic AcidDrug
Also called Iron Tablets
Ferrous Sulphate 600mg, thrice daily + Folic Acid, 5mg daily
| Study group | Role | What they receive |
|---|---|---|
| Jobelyn + Ferrous Sulphate + Folic Acid | Active comparator | Caps Jobelyn 250mg, 12 hourly + Ferrous Sulphate 600mg thrice daily + Folic Acid 5mg daily Receives: Dietary Supplement: Jobelyn; Drug: Ferrous Sulphate + Folic Acid |
| Ferrous Sulphate + Folic Acid | Active comparator | Ferrous Sulphate 600mg, thrice daily + Folic Acid, 5mg daily Receives: Drug: Ferrous Sulphate + Folic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anaemia
Change in haematological parameters
Measured: 3 months
Secondary outcomes (1)
morbidity
Reduced postoperative morbidity
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lagos State University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Forever Product Limited. Lagos, Nigeria
- Responsible party
- Principal investigator, Dr. A. Tayo, Lagos State University
- Investigators
- Adetokunbo O Tayo, M.D., Principal investigator, Lagos State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670955
- Sponsor's protocol ID
- LASUTH/08/2012
- Status last verified
- May 2016
- First submitted
- 18 Aug 2012
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Brohan M, Jerkovic V, Collin S. Potentiality of red sorghum for producing stilbenoid-enriched beers with high antioxidant activity. J Agric Food Chem. 2011 Apr 27;59(8):4088-94. doi: 10.1021/jf1047755. Epub 2011 Mar 7.
PubMed 21381750Geera B, Ojwang LO, Awika JM. New highly stable dimeric 3-deoxyanthocyanidin pigments from sorghum bicolor leaf sheath. J Food Sci. 2012 May;77(5):C566-72. doi: 10.1111/j.1750-3841.2012.02668.x. Epub 2012 Apr 10.
PubMed 22489620Kayode AP, Nout MJ, Linnemann AR, Hounhouigan JD, Berghofer E, Siebenhandl-Ehn S. Uncommonly high levels of 3-deoxyanthocyanidins and antioxidant capacity in the leaf sheaths of dye sorghum. J Agric Food Chem. 2011 Feb 23;59(4):1178-84. doi: 10.1021/jf103963t. Epub 2011 Jan 25.
PubMed 21322653Yang L, Browning JD, Awika JM. Sorghum 3-deoxyanthocyanins possess strong phase II enzyme inducer activity and cancer cell growth inhibition properties. J Agric Food Chem. 2009 Mar 11;57(5):1797-804. doi: 10.1021/jf8035066.
PubMed 19256554Shih CH, Siu SO, Ng R, Wong E, Chiu LC, Chu IK, Lo C. Quantitative analysis of anticancer 3-deoxyanthocyanidins in infected sorghum seedlings. J Agric Food Chem. 2007 Jan 24;55(2):254-9. doi: 10.1021/jf062516t.
PubMed 17227050Camargo Filho I, Cortez DA, Ueda-Nakamura T, Nakamura CV, Dias Filho BP. Antiviral activity and mode of action of a peptide isolated from Sorghum bicolor. Phytomedicine. 2008 Mar;15(3):202-8. doi: 10.1016/j.phymed.2007.07.059. Epub 2007 Sep 24.
PubMed 17890069Burdette A, Garner PL, Mayer EP, Hargrove JL, Hartle DK, Greenspan P. Anti-inflammatory activity of select sorghum (Sorghum bicolor) brans. J Med Food. 2010 Aug;13(4):879-87. doi: 10.1089/jmf.2009.0147.
PubMed 20673059Park JH, Darvin P, Lim EJ, Joung YH, Hong DY, Park EU, Park SH, Choi SK, Moon ES, Cho BW, Park KD, Lee HK, Kim MJ, Park DS, Chung IM, Yang YM. Hwanggeumchal sorghum induces cell cycle arrest, and suppresses tumor growth and metastasis through Jak2/STAT pathways in breast cancer xenografts. PLoS One. 2012;7(7):e40531. doi: 10.1371/journal.pone.0040531. Epub 2012 Jul 6.
PubMed 22792362Wu L, Huang Z, Qin P, Yao Y, Meng X, Zou J, Zhu K, Ren G. Chemical characterization of a procyanidin-rich extract from sorghum bran and its effect on oxidative stress and tumor inhibition in vivo. J Agric Food Chem. 2011 Aug 24;59(16):8609-15. doi: 10.1021/jf2015528. Epub 2011 Jul 29.
PubMed 21780844Devi PS, Kumar MS, Das SM. Evaluation of antiproliferative activity of red sorghum bran anthocyanin on a human breast cancer cell line (mcf-7). Int J Breast Cancer. 2011;2011:891481. doi: 10.4061/2011/891481. Epub 2011 Oct 16.
PubMed 22312562Awika JM, McDonough CM, Rooney LW. Decorticating sorghum to concentrate healthy phytochemicals. J Agric Food Chem. 2005 Aug 10;53(16):6230-4. doi: 10.1021/jf0510384.
PubMed 16076098
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II/III Randomized, Blinded Study to Demonstrate the Safety and Effectiveness of Jobelyn ( a Herbal Preparation ) in Pre-operative Management of Anaemia in Gynaecological Patients
- ClinicalTrials.gov ID
- NCT01670955
- Acronym / sponsor ID
- LASUTH/08/2012
- Conditions
- Anemia
- Keywords
- Anemia, preoperative, gynecological patients, Sorghum bicolor, Packed Cells Volume
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Lagos State UniversityUniversity, hospital or other
- Collaborators
- Health Forever Product Limited. Lagos, Nigeria
- Study start
- Dec 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 23 Aug 2012 (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.
PROTOCOL FOR THE STUDY OF THE SAFETY AND EFFICACY OF JOBELYN, IN THE PREOPERATIVE MANAGEMENT OF ANAEMIA IN GYNAECOLOGICAL PATIENTS
Detailed description
It has long been known that anaemia increases the risk of death and complications in patients who have cardiovascular surgery, but results of a recent study show that these risks are increased in patients with anaemia who undergo various types of surgery, including gynaecological procedures.
Compared with patients without anaemia, the risk of death within 30 days after surgery was 42% higher among patients with anaemia. In addition, patients with anemia were 35% more likely to experience cardiac, respiratory, urinary, and wound complications as well as sepsis and blood clots.
Because even mild anaemia increases the risk of postoperative morbidity in patients undergoing major non-cardiac surgery, doctors need to consider preoperative treatment of anaemia when possible. More research is needed to establish the efficacy, safety and cost-effectiveness of pre-operative anaemia management.
One of the major clinical issues in many gynaecological patients in Nigeria is that of optimizing the packed cell volume before surgery. Anaemia could be traced to multiple factors notable of which are high prevalence of infection, worm infestation and malnutrition (R). In other to reduce the waiting time and reduce morbidity and mortality associated with surgery, it is important to correct the packed cell volume adequately before surgery.
The traditional method of correcting PCV involves the use of 'routine' haematinics such as Ferrous sulphate, Folic acid and Multivitamin. This is in addition to dietary advice. While the efficacy of these drugs has been well acknowledged in clinical practice, there is dearth of literatures on their specific influence on haematological parameters. Majority of Nigerians are gradually having a change of perception about traditional medicines with gradual shift towards their use. It is believed that traditional drugs act faster and more effective than other orthodox drugs in conventional use. One of such area is in the correction of anaemia.
Sorghum bicolor, a grain long used in Africa for its high nutritional value also exhibits strong antioxidant properties and antiinflammatory effects. The traditional preparation of Sorghum bicolor has an oxygen radical absorbance capacity (ORAC) OF 37,622 micro mole TE/g. This is much higher than other botanical preparations. Complementing the antioxidant properties, Sorghum bicolor also exhibits anti inflammatory effects and demonstrated selective COX-2 inhibition, providing effective reduction in inflammation without residual side effects.
Sorghum bicolor extract has been shown to increase the haematocrit and haemoglobin level and reduce the white cell count in trypanosome brucei brucei induced anaemia in experimental rabbits. These effects were conclusive within 49 days of experimentation. Animals sacrificed after the administration of lethal dose Jobelyn were shown to have congestion of the liver, kidneys and lungs. This might be as a result of direct effect on these organs or a sign of cardiotoxicity. However there is a wide therapeutic range.
Sorghum bicolor is the proprietary name for the product intended to treat sickle cell disease. It is exactly the same as jobelyn which is currently marketed as a nutritional supplement. Jobelyn is marketed in 250mg capsules of sorghum bicolor leaf extract. The product is widely marketed in the United States and in Nigeria. Many pregnant women have been using it regularly for a long time without any report of adverse effect.
The sorghum bicolor extract is expected to increase the haematocrit of' pregnant women within a short time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jobelyn + Ferrous Sulphate + Folic Acid | Active comparator | Dietary Supplement: Jobelyn, Drug: Ferrous Sulphate + Folic AcidCaps Jobelyn 250mg, 12 hourly + Ferrous Sulphate 600mg thrice daily + Folic Acid 5mg daily |
| Ferrous Sulphate + Folic Acid | Active comparator | Drug: Ferrous Sulphate + Folic AcidFerrous Sulphate 600mg, thrice daily + Folic Acid, 5mg daily |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Mild to moderate anaemia
- Asymptomatic severe anaemia
- Non life threatening gynaecological condition
Key exclusion criteria (4 listed)
- Failure to give informed consent
- Symptomatic severe anaemia
- Pregnancy
- Malignancies and Chronic inflammatory disease
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 |
|---|---|---|
| JobelynAlso: Sorghum bicolor extractJobelyn is a sorghum bicolor extract marketed as dietary supplement | Dietary supplement | Jobelyn + Ferrous Sulphate + Folic Acid |
| Ferrous Sulphate + Folic AcidAlso: Iron TabletsFerrous Sulphate 600mg, thrice daily + Folic Acid, 5mg daily | Drug | Ferrous Sulphate + Folic Acid, Jobelyn + Ferrous Sulphate + Folic Acid |
Primary outcome
Anaemia
Time frame: 3 months
Change in haematological parameters
1 secondary outcome
morbidity
Time frame: 3 months
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 18 May 2016.
- Background: PubMed 21381750Brohan M, Jerkovic V, Collin S. Potentiality of red sorghum for producing stilbenoid-enriched beers with high antioxidant activity. J Agric Food Chem. 2011 Apr 27;59(8):4088-94. doi: 10.1021/jf1047755. Epub 2011 Mar 7.
- Background: PubMed 22489620Geera B, Ojwang LO, Awika JM. New highly stable dimeric 3-deoxyanthocyanidin pigments from sorghum bicolor leaf sheath. J Food Sci. 2012 May;77(5):C566-72. doi: 10.1111/j.1750-3841.2012.02668.x. Epub 2012 Apr 10.
- Background: PubMed 21322653Kayode AP, Nout MJ, Linnemann AR, Hounhouigan JD, Berghofer E, Siebenhandl-Ehn S. Uncommonly high levels of 3-deoxyanthocyanidins and antioxidant capacity in the leaf sheaths of dye sorghum. J Agric Food Chem. 2011 Feb 23;59(4):1178-84. doi: 10.1021/jf103963t. Epub 2011 Jan 25.
- Background: PubMed 19256554Yang L, Browning JD, Awika JM. Sorghum 3-deoxyanthocyanins possess strong phase II enzyme inducer activity and cancer cell growth inhibition properties. J Agric Food Chem. 2009 Mar 11;57(5):1797-804. doi: 10.1021/jf8035066.
- Background: PubMed 17227050Shih CH, Siu SO, Ng R, Wong E, Chiu LC, Chu IK, Lo C. Quantitative analysis of anticancer 3-deoxyanthocyanidins in infected sorghum seedlings. J Agric Food Chem. 2007 Jan 24;55(2):254-9. doi: 10.1021/jf062516t.
- Background: PubMed 17890069Camargo Filho I, Cortez DA, Ueda-Nakamura T, Nakamura CV, Dias Filho BP. Antiviral activity and mode of action of a peptide isolated from Sorghum bicolor. Phytomedicine. 2008 Mar;15(3):202-8. doi: 10.1016/j.phymed.2007.07.059. Epub 2007 Sep 24.
- Background: PubMed 20673059Burdette A, Garner PL, Mayer EP, Hargrove JL, Hartle DK, Greenspan P. Anti-inflammatory activity of select sorghum (Sorghum bicolor) brans. J Med Food. 2010 Aug;13(4):879-87. doi: 10.1089/jmf.2009.0147.
- Background: PubMed 22792362Park JH, Darvin P, Lim EJ, Joung YH, Hong DY, Park EU, Park SH, Choi SK, Moon ES, Cho BW, Park KD, Lee HK, Kim MJ, Park DS, Chung IM, Yang YM. Hwanggeumchal sorghum induces cell cycle arrest, and suppresses tumor growth and metastasis through Jak2/STAT pathways in breast cancer xenografts. PLoS One. 2012;7(7):e40531. doi: 10.1371/journal.pone.0040531. Epub 2012 Jul 6.
- Background: PubMed 21780844Wu L, Huang Z, Qin P, Yao Y, Meng X, Zou J, Zhu K, Ren G. Chemical characterization of a procyanidin-rich extract from sorghum bran and its effect on oxidative stress and tumor inhibition in vivo. J Agric Food Chem. 2011 Aug 24;59(16):8609-15. doi: 10.1021/jf2015528. Epub 2011 Jul 29.
- Background: PubMed 22312562Devi PS, Kumar MS, Das SM. Evaluation of antiproliferative activity of red sorghum bran anthocyanin on a human breast cancer cell line (mcf-7). Int J Breast Cancer. 2011;2011:891481. doi: 10.4061/2011/891481. Epub 2011 Oct 16.
- Background: PubMed 16076098Awika JM, McDonough CM, Rooney LW. Decorticating sorghum to concentrate healthy phytochemicals. J Agric Food Chem. 2005 Aug 10;53(16):6230-4. doi: 10.1021/jf0510384.
- Individual participant dataSharing planned: No
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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.
Adetokunbo O Tayo, M.D. principal investigator
Lagos State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Jobelyn and Ferrous Sulphate + Folic Acid in people with Anemia, run by Lagos State University at 1 site in Nigeria.
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 4 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 18 May 2016. 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 Nigeria. 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 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?
Anaemia (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01670955, which also lists 11 linked publications.
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 18 May 2016.