Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201901852059636 Date of Registration: 23/01/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title MOJEAGA Trial
Official scientific title Efficacy and safety of Mojeaga® (a special blend of Alchornea, Pennisetum, and Sorghum extracts) in combination with conventional oral iron therapy for correcting anemia in gynecological and obstetrics patients: a pilot randomized clinical trial
Brief summary describing the background and objectives of the trial Mojeaga® (a special blend of Alchornea, Pennisetum, and Sorghum extracts) may be very effective in correcting anemia in gynecological and obstetrics patients. Limited available studies in patients suggest a seemingly high efficacy but provide little information on benefits and adverse events. Study on its use in treatment of iron deficiency anemia in adult patients who are intolerant to oral iron preparations or who refuse blood transfusion is highly desirable. To our knowledge, there is no prior randomized study on the effectiveness of Mojeaga when co-administered with conventional oral iron therapy schedule for correction of anemia in Obstetrics and gynecology practice. To determine the effectiveness, safety and tolerability of Mojeaga as adjunct to conventional iron therapy for correction of anemia in gynecological and obstetrics patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MOJEAGA Trial
Disease(s) or condition(s) being studied Haematological Disorders,Infections and Infestations,Obstetrics and Gynecology,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied Fertility-female,Nil
Purpose of the trial Treatment: Drugs
Anticipated trial start date 04/03/2019
Actual trial start date
Anticipated date of last follow up 31/08/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mojeaga and conventional oral Therapy 50 mls of Mojeaga will be administered three time daily in conjunction with iron therapy Astyfer capsules two times a day Two weeks Standard doses of 50 mls of Mojeaga will be administered three time daily in conjunction with iron therapy Astyfer (Til Healthcare PVT Ltd, Andhra Pradesh, 517588 India) capsules two times a day (breakfast and dinner) 30
Control Group conventional oral iron therapy alone one capsule or 10 mls 2 times daily 2 weeks Standard doses of one capsule of Astyfer will be administered alone two times a day (breakfast and dinner) for 2 weeks. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Obstetrics patients with confirmed clinical and laboratory diagnosis of anemia (<10.0 g/dl) Gynecological adult patients with confirmed clinical and laboratory diagnosis of anemia (<10.0 g/dl) Patients with normal liver markers or profiles. Patients with renal function markers or profiles. • Pregnant women at first trimester of pregnancy (because of nausea and vomiting at this period). • Multiple gestation • Chronic medical disorders including HIV/AIDS, Cancers, etc. • Women on chronic medications that cause anemia Adult: 19 Year-44 Year 18 Year(s) 45 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/04/2019 Nnamdi Azikiwe University Teaching Hospital
Ethics Committee Address
Street address City Postal code Country
49 Nnewi Onitsha Road Nnewi 435001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. The mean level of hemoglobin. Two weeks post therapy
Secondary Outcome 1. Proportion of patients with persisting anemic symptoms (weakness, easy fatigability) . 2. Incidence of any maternal adverse events (such as diarrhea, nausea, vomiting and colitis)y. 3. Incidence of any fetal adverse events (such as preterm labour or jaundice). 4. Mean levels of renal function parameters (serum electrolyte, urea and creatinine). 5. Mean levels of liver function parameters (AST, ALT and ALP). Two weeks post initial therapy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nnamdi Azikiwe Uiversity Teaching Hospital Nnewi Nnewi Onitsha Road Nnewi 435001 Nigeria
University Of Nigeria Teaching Hospital 22 Enugu Portharcourt Road Enugu 430000 Nigeria
Parklane Hospital 33 Behind Shoprite Enugu Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
MOJEAGA INTERNATIONAL VENTURES LTD 2A ERHUOMASE STREET, IDUMWOMWINA, OFF BENIN AUCHI ROAD BENIN CITY Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mr Michael Ojeaga Alugeh 2A Erhuomase Street, Idumwomawina, Off Benin-Auchi Road, Benin City, Edo State Benin city Nigeria Commercial Sector/Industry
Secondary Sponsor MOJEAGA INTERNATIONAL VENTURES 2A ERHUOMASE STREET BENIN CITY Nigeria Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Dr Emmanuel Ugwu 55 Opposite EEDC Enugu Nigeria
Prof Joseph Ikechebelu 49 Nnewi Onitsha Road Nnewi Nigeria
Dr Angela Ugwu 55 Opposite EEDC Enugu Nigeria
DR IFEOMA AJUBA 49 Nnewi Onitsha Road Nnewi Nigeria
DR CHUKWUEMEKA OKORO 49 Nnewi Ontsha Road Nnewi Nigeria
Dr Euzebus Ezugwu 55 Enugu Portharcourt Road Enugu Nigeria
Prof Charles Esimone 5 Awka Onitsha Raod Awka Nigeria
DR JOSEPH ENEBE 33 Behind Shop Rite Enugu Nigeria
DR. CHIGOZIE .G. OKAFOR 49 Nnewi Onitsha Road Nnewi Nigeria
MR CHIKA ASUOHA 49 Nnewi Onitsha Road Nnewi Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator George Eleje georgel21@yahoo.com +2348068117444 49 Nnewi Onitsha Road
City Postal code Country Position/Affiliation
Nnewi Nigeria Consultant Nnamdi Azikiwe University Teaching Hospital Nnewi
Role Name Email Phone Street address
Public Enquiries John Nwankwere johnnwankwere@yahoo.com +2348037271224 3 Nnewi Awka Etiti Road
City Postal code Country Position/Affiliation
Nnewi Nigeria Distributor
Role Name Email Phone Street address
Scientific Enquiries Emmanuel Ugwu vajel@yahoo.com +2348037790402 55 opposite EEDC
City Postal code Country Position/Affiliation
Enugu Nigeria Consultant University of Nigeria Teaching Hospital Ituku Ozalla Enugu
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes PROFORMA: Efficacy and safety of Mojeaga® (a special blend of Alchornea, Pennisetum, and Sorghum extracts) in combination with conventional oral iron therapy for correcting anemia in gynecological and obstetrics patients: a pilot randomized clinical trial NAME OF DOCTOR…………………………………………CODE NUMBER OF PATIENT……………………….……………. 1. COMPUTER NUMBER OF PATIENT……………………………………… ...…..(2) GENDER……………………… 3. DATE OF RECRUITMENT……………….... (4) TIME……………… (5) AGE……………...………………… (6.) LMP------------------ (7) GESTATIONAL AGE----------------------------------------------------- TICK[X] OR WRITE WHICHEVER IS APPROPRIATE. 9 RETROVIRAL DISEASE STATUS a.) Negative [ ] (b) Positive [ ] 11. HIGHEST EDU LEVEL…………………………………12.) OCCUPATION (Specify)…………………………….…………………. 13. PREVIOUS ANAEMIA? a.) YES----b.) NO------ (15B) Known Hypertensive Yes [ ], NO [ ] 16. MARITAL STATUS a.) Single [ ] (b) Married [ ] 17. FINDINGS AT CLINICAL EXAMINATION before therapy………………………………………?TICK [√] below: VARIABLE before therapy PRESENCE ABSENCE Epigastrric pain Nausea Vomiting Dizziness Weakness Hematemesis 18. FINDINGS AT CLINICAL EXAMINATION AFTER therapy…………………………………?TICK [√] below: VARIABLE AFTER therapy PRESENCE ABSENCE Epigastric pain Nausea Vomiting Dizziness Weakness Hematemesis 19. SOME LABORATORY PARAMETERS LABORATORY VARIABLE VALUES BEFORE THERAPY VALUES AFTER THERAPY NORMAL RANGES Na K Bicarbonate AST ALP ALT PCV Hb wbc Platelets Informed Consent Form BETWEEN MARCH 2019 TO SEPTEMBER 2019 Via e-mail
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Nil No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information