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.: PACTR202308508196184 Date of Approval: 07/08/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Assessing the Effects of Solanum torvum Tea Consumption on Cardiometabolic Indices in People living with Hypertension
Official scientific title Assessing the Effects of Solanum torvum Tea Consumption on Cardiometabolic Indices in People living with Hypertension
Brief summary describing the background and objectives of the trial BACKGROUND The use of antihypertensive medications may come with undesirable side effects, which may discourage patients from taking the prescribed medication in order to manage their condition. This may likely lead to complications associated with this condition. Therefore, it is essential to look for natural remedies and functional foods such as Solanum torvum that is packed with bioactive compounds that protect the body against oxidative stress, improve bodily function, fight against infections and may help manage the menace of hypertension. This would give individuals and healthcare providers better control of this condition and its complications. The Objective of this trial is to assess the effects of Solanum torvum tea consumption on Cardiometabolic Indices in people living with Hypertension.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 14/08/2023
Actual trial start date 15/09/2023
Anticipated date of last follow up 10/04/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 45
Recruitment status Active, not 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
Single Group Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Solanum torvum Tea Daily(7 days in a week) 4 weeks Participants in this single arm study would receive 30 pieces of Solanum torvum tea bags, that would be consumed daily for a period of 30 days(4 weeks). 45
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Adults of both sexes from the age of 18 and above (≥18), 2. Participants who are diagnosed of hypertension and 3. Visit the hypertensive unit at the Mampong Government Hospital. 1.Pregnant women 2. People with compromised immune system (i.e., HIV and others) and 3. mentally challenged individuals. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
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 02/05/2023 Committee on Human Research. Publication and Ethics
Ethics Committee Address
Street address City Postal code Country
School of Medicine and Dentistry, KNUST, University Post Office, Kumasi, Ghana. Kumasi 0233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To measure the Cardio-protective effects of Solanum torvum tea intake amongst study participants. Baseline and End line
Secondary Outcome 1.To determine the microbial safety of Solanum torvum/Turkey berry tea that would be administered to study participants. 2.To measure the hypolipidemic effects of Solanum torvum tea intake amongst study participants. 3.To measure the effect of Solanum torvum tea intake on the body composition (weight, BMI, total body fat, visceral fat, basal metabolic rate and metabolic age) of study participants. Baseline and End line
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mampong Government Hospital 2HRV Mampong R68 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Marina Tandoh KNUST Department of Biochemistry and Biotechnology Kumasi 0233 Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Marina Tandoh KNUST, Department of Biochemistry and Biotechnology Kumasi 0233 Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
Hamdia Ibrahim Seidu KNUST, Department of Biochemistry and Biotechnology Kumasi 0233 Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Marina Tandoh mtandoh@yahoo.com +233248989545 KNUST, Department of Biochemistry and Biotechnology
City Postal code Country Position/Affiliation
Kumasi 0233 Ghana Lecturer
Role Name Email Phone Street address
Public Enquiries Marina Tandoh mtandoh@yahoo.com +233248989545 KNUST, Department of Biochemistry and Biotechnology
City Postal code Country Position/Affiliation
Kumasi 0233 Ghana Lecturer
Role Name Email Phone Street address
Scientific Enquiries Marina Tandoh mtandoh@yahoo.com +233248989545 KNUST, Department of Biochemistry and Biotechnology
City Postal code Country Position/Affiliation
Kumasi 0233 Ghana Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification. Informed Consent Form,Statistical Analysis Plan,Study Protocol Documents and Data will be available 6 months after publication up to 2 years Principal Investigator, Collaborators and other Researchers who would require the data for further research on this topic and do not intend to use the collected data for commercial purposes.
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