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.: PACTR202405559013998 Date of Approval: 02/05/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Clinical trial of traditional antihypertensive herb for the management of preeclampsia
Official scientific title CLInical trial of Pear Seeds for the MAnagement of Preeclampsia
Brief summary describing the background and objectives of the trial Our earlier study has shown that glycoside extracts of native pear seeds are potent in the management of vascular damage. Recently we conducted a preeclinical trial and observed a remarkable phenotype, where crude extract of pear seeds induced the recovery of resorpted uterine and foetal growth retardations. In furtherance to this remarkable phenotype, the loss glycogen stores of the placenta were significantly restored. Since pear seeds are currently used for the management of preeclampsia in Nigeria, we propose to conduct a rigorously designed clinical trial of the crude extract to aid its integration in orthodox preeclampsia management. Our aim is to conduct a placebo-controlled randomised clinical trial where women with preeclampsia will be administered the crude extract compared to a placebo group.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CLIPSMAP
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 25/11/2024
Actual trial start date 02/12/2024
Anticipated date of last follow up 01/11/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 86
Actual target sample size (number of participants)
Recruitment status Recruiting
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo Control Saline 200 microlitres 3 months Placebo group will receive daily, enteric capsules containing just 200 microlitres of saline. 43 Placebo
Experimental Group Treatment Group 200 µl of 200mg/ml crude extract of native pear seeds encapsulated in an enteric coated softgel, to be administered daily. 3 months The treatment group are women with history of preeclampsia, and confirmed preeclamptic at the time. They will receive 200 µl of 200mg/ml crude extract of native pear seeds encapsulated in an enteric coated softgel, to be administered daily. 43
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Provision of consent to participate Pregnancy <6 months Multigravida Presence of preeclampsia with a defined medical management Unwillingness to participate'' Pregnancy without preeclampsia or pregnancy >6 months Any other pregnancy complications aside preeclampsia Smoking and drinking Primigravida Adult: 19 Year-44 Year 24 Year(s) 40 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 04/01/2024 Imo State University Ethics Review Board
Ethics Committee Address
Street address City Postal code Country
Imo State University, Okigwe Road, Owerri Owerri 234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Blood pressure and proteinuria Bi-weekly
Secondary Outcome sFLT/PLGF, plasma and placental inflammatory cytokines. Plasma measurements is biweekly
Primary Outcome Birth Weight and Fetal Mortality At the third trimester and at confinement
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Center Owerri Amakohia Road, Owerri, Imo State Owerri Nigeria
Department of Medical Biochemistry Imo State University Department of Medical Biochemistry, Faculty of Biochemistry, Imo State University, Owerri Owerri 234 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Tetfund 6 Zambezi Crescent, Off Aguiyi Ironsi Street, Maitama, Abuja, F.C.T., Nigeria Abuja Nigeria
UKRI Applied Global Health Research Medical Research Council, Polaris House North Star Avenue Swindon SN2 1FL United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Imo State University Okigwe Road, Owerri, Imo State Owerri Nigeria University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Peter Amadi pamadi@ualberta.ca +2348061159916 Department of Biochemistry, Imo State University
City Postal code Country Position/Affiliation
Owerri Nigeria Principal Investigator Imo State University
Role Name Email Phone Street address
Scientific Enquiries Peter Amadi pamadi@ualberta.ca +17802182257 Department of Pediatrics, University of Alberta, Canada
City Postal code Country Position/Affiliation
Owerri Nigeria Postdoc University of Alberta
Role Name Email Phone Street address
Public Enquiries Justice Osuoha Justice_Osuoh@uniport.edu.ng +2348063427117 Imo State Polytechnic, Umuagwo
City Postal code Country Position/Affiliation
Umuagwo Nigeria Lecturer Imo State Polytechnic Umuagwo
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes IPD obtained through this study may be provided to qualified researchers with similar academic or research interest and with reasonable cause. Data or samples shared will be coded, with no patient health information included. Approval of the request and execution of all applicable agreements like material transfer agreement are prerequisites to the sharing of data with the researchers making the request. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 3 years according to funder's policies Will be accessible through a formal request made to the PI for consideration
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 02/11/2024 Planned phase 2 Phase-1 Phase-2
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 11/01/2024 Logistics Delay 02 Sep 2024 14 Oct 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 02/11/2024 We anticipate to commence the phase 2 trial on this date 14 Oct 2024 25 Nov 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 02/11/2024 This trial is a prospective registration and not a retrospective application. 02 Dec 2024
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 11/01/2024 Feasibility in recruiting the desired number of study participants 01 May 2025 01 Nov 2027
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 11/01/2024 To attain sufficient power based on the effect size, in order to attain statistical significance 86 796
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 27/04/2024 This sample size is sufficient to achieve a statistical significance based on the effect size. The total number of participants in the intervention section is 86. 796 86
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 28/02/2025 recruiting Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 02/11/2024 Additional proposed endpoint. Primary Outcome, Birth Weight and Fetal Mortality, At the third trimester and at confinement
Section Name Field Name Date Reason Old Value Updated Value
Recruitment Centre RecruitmentCentre List 02/11/2024 Proposed Multi-centered trial Department of Medical Biochemistry Imo State University, Department of Medical Biochemistry, Faculty of Biochemistry, Imo State University, Owerri, Owerri, 234, Nigeria
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 11/01/2024 Re-approval of the study due to delay in start dates and changes in sample size TRUE, Imo State University Ethics Review Board, Imo State University, Okigwe Road, Owerri, Owerri, 234, Nigeria, , 05 Dec 2022, +2347064565620, fobs@imsu.edu.ng, TRUE, Imo State University Ethics Review Board, Imo State University, Okigwe Road, Owerri, Owerri, 234, Nigeria, , 04 Jan 2024, +2347064565620, fobs@imsu.edu.ng, 26925_25875_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 11/01/2024 Re-approval after logistical delays in a feasible commencement period and change in sample size TRUE, Imo State University Ethics Review Board, Imo State University, Okigwe Road, Owerri, Owerri, 234, Nigeria, , 04 Jan 2024, +2347064565620, fobs@imsu.edu.ng, 26925_25875_4737.pdf TRUE, Imo State University Ethics Review Board, Imo State University, Okigwe Road, Owerri, Owerri, 234, Nigeria, , 04 Jan 2024, +2347064565620, fobs@imsu.edu.ng, 26925_25875_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 02/11/2024 Funding Approval in view UKRI Applied Global Health Research, Medical Research Council, Polaris House North Star Avenue, Swindon, SN2 1FL, United Kingdom, Funding Agency,
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 10/10/2023 The reviewer required more information A link to summary results will be available within the trial registration record will be available within 12 months of the study commencement IPD obtained through this study may be provided to qualified researchers with similar academic or research interest and with reasonable cause. Data or samples shared will be coded, with no patient health information included. Approval of the request and execution of all applicable agreements like material transfer agreement are prerequisites to the sharing of data with the researchers making the request.