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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607636659381 Date of Registration: 21/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The use of polyherbal tea as intervention in the management of metabolic syndrome in type 2 diabetes/hypertensive patients in a health facility in Ashanti region of Ghana: A randomized controlled trial
Official scientific title The use of polyherbal tea as intervention in the management of metabolic syndrome in type 2 diabetes/hypertensive patients in a health facility in Ashanti region of Ghana: A randomized controlled trial
Brief summary describing the background and objectives of the trial Metabolic syndrome (MetS) is a group of metabolic disorders made up of elevated central obesity and any 2 of the following: insulin resistance, high blood pressure (hypertension), dyslipidemia, high waist circumference, high waist-to-hp circumference, obesity and high fasting plasma glucose (Rochlani et al., 2017). According to Hamooya et al., 2025, 25% of the world's adult population have MetS and are twice likely to have heart attack, stroke, or die as compared to non-MetS people (Correa et al., 2020; Abban et al., 2017). There is no single remedy for MetS, rather the individual conditions are taken into consideration for treatment for a long time, leading to drug-linked complications, reduced adherence to drug intake, and high care costs (Palla et al., 2021). Studies have shown that lifestyle changes such as dietary modifications are potent in decreasing many of the conditions leading to MetS (Correa et al., 2020; Palla et al., 2021). To prevent MetS and other diseases, a diet rich in phytochemicals can be added to meal as a form of lifestyle modification (Correa et al., 2020) Phytochemicals especially antioxidants have a positive effect on oxidative stress leading to reduction in many diseases in the body. Objective of the trial : is to estimate the effectiveness of formulated polyherbal tea in type 2 diabetes/hypertensive patients in a health facility in the Ashanti region of Ghana.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Polyherbal tea
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 08/07/2026
Actual trial start date 16/07/2026
Anticipated date of last follow up 15/09/2026
Actual Last follow-up date 30/09/2026
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Recruiting
Publication URL Springer
Secondary Ids Issuing authority/Trial register
CHRPE AP 409 26 COMMITTEE ON HUMAN RESEARCH PUBLICATION AND ETHICS
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 by using procedures such as coin-tossing or dice-rolling Numbered containers Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group no placebo treatment no dosage Three months participants will continue to take normal medication given to them in the hospital and nothing except nutritional education 20 Uncontrolled
Experimental Group formulated polyherbal tea Twice daily (one after breakfast and the other after dinner) Three months participants on normal medication will be given the formulated polyherbal tea and nutritional counselling 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients suffering from type 2 diabetes or hypertension and are between the ages 21 and 75 years will be included Patients suffering from type 2 diabetes or hypertension and are below 21 years and above 75 years will be encluded Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 75 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 14/04/2026 Committee on Human Research Publication and Ethics
Ethics Committee Address
Street address City Postal code Country
Room7, block I, School of medicine and dentistry, KNUST Kumasi AK-0308 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome It is expected that the effectiveness of the polyherbal tea on metabolic syndrome in participants on normal medication as compared to control group on medication only will be established. after every 30days of consuming the tea fasting blood sugar level, blood pressure level and cholesterol level participants for 90days
Secondary Outcome It is expected that the safety assessment (acute toxicity test, liver test, kidney test, glycaemic test and lipid profile test) of tea on rats will be determined rats will be given tea for 14 days to check toxicity of tea and different groups of rats will be given tea, distilled water and green for 28 days for safety assessment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
St. Michaels Catholic Hospital P.O.Box 10, Jachie-Pramso Ashanti AT-0309 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Rira Esi Jones Danso Yeboah P.O.BOX 1362, HO, VOLTA REGION HO VH-1660 Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor RITA ESI JONES DANSO YEBOAH BOX HP 1362, HO HO VH-1660 Ghana SELF
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator RITA ESI JONES DANSO YEBOAH esinkrumah1@yahoo.com +233244922198 P.O.BOX 1362, HO, VOLTA REGION
City Postal code Country Position/Affiliation
HO VH-1660 Ghana PHD STUDENT
Role Name Email Phone Street address
Public Enquiries CHRISTOPHER LARBIE ekowlarbie@gmail.com +233243445961 BIOCHEMISTRY AND BIOTECHNOLOGY DEPARTMENT, KNUST
City Postal code Country Position/Affiliation
KUMASI AK-0308 Ghana MAIN SUPERVISOR
Role Name Email Phone Street address
Scientific Enquiries CHRISTOPHER LARBIE ekowlarbie@gmail.com +233243445961 BIOCHEMISTRY AND BIOTECHNOLOGY DEPARTMENT, KNUST
City Postal code Country Position/Affiliation
KUMASI AK-0308 Ghana MAIN SUPERVISOR
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All data collected for the study will be coded in order not to disclose the identity of the participants and then shared with anyone who wishes to access the data Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 3months -1year after publication Anyone who wishes to access the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Springer nature 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 04/06/2026 work in progress Phase-0 Phase-1
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 26/06/2026 that is the stage the work is in Phase-1 Phase-0
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Acronym 18/06/2026 Required PHT Polyherbal tea
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 26/06/2026 that is where we are 11 May 2026 08 Jul 2026
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 04/06/2026 that is when work will start 18 May 2026 11 Jun 2026
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 18/06/2026 Required 11 Jun 2026 25 Jun 2026
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 26/06/2026 hope to start 25 Jun 2026 14 Jul 2026
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 04/07/2026 presently sensitization is taking place where the trial is explained to participants and participants are given chase to ask questions about the trial in order to have a full understanding of what is to be done 14 Jul 2026 16 Jul 2026
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 04/06/2026 hope to finish by then 11 Aug 2026 22 Sep 2026
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 18/06/2026 Required 22 Sep 2026 25 Jun 2026
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 26/06/2026 hope to finish by then 25 Jun 2026 15 Sep 2026
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 04/06/2026 sure to have completed 26 Aug 2026 30 Sep 2026
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 04/06/2026 that is the stage of the work Not yet recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 26/06/2026 work has not started only sensitization and publishing in the study area Recruiting Active, not recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 14/07/2026 that is the stage we now Active, not recruiting Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Inclusion criteria 14/05/2026 Requested to make statement clear Diabetic/hypertensive patients between 21 years old and 75 years old will be included Patients suffering from type 2 diabetes or hypertension and are between the ages 21 and 75 years will be included
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Exclusion criteria 14/05/2026 Requested to make statement clear Diabetic/Hypertensive patients below 21 years old and above 75 years old will be excluded Patients suffering from type 2 diabetes or hypertension and are below 21 years and above 75 years will be encluded
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 04/06/2026 requested to select appropriate age included Aged: 65 Year(s)-79 Year(s) Adult: 18 Year(s)-44 Year(s), Middle Aged: 45 Year(s)-64 Year(s), Aged: 65 Year(s)-79 Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 04/06/2026 Requested to change Control Group, control tea, Twice daily (one after breakfast and the other after dinner), Three months, yellow labeled lipton tea, 20, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 04/06/2026 requested for the explanation Control Group, control tea, Twice daily (one after breakfast and the other after dinner), Three months, yellow labeled lipton tea, 20, Placebo Control Group, control tea, Twice daily (one after breakfast and the other after dinner), Three months, yellow labeled lipton tea bags will be bought from a supermarket, and will be used as the control tea , 20, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 18/06/2026 requested for the explanation Control Group, control tea, Twice daily (one after breakfast and the other after dinner), Three months, yellow labeled lipton tea bags will be bought from a supermarket, and will be used as the control tea , 20, Placebo Control Group, control tea, Twice daily (one after breakfast and the other after dinner), Three months, yellow labeled lipton tea bags will be bought from a supermarket, labels were removed, placed in zip lock bags just as the formulated polyherbal tea and will be used as the control tea. , 20, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 26/06/2026 not required Control Group, control tea, Twice daily (one after breakfast and the other after dinner), Three months, yellow labeled lipton tea bags will be bought from a supermarket, labels were removed, placed in zip lock bags just as the formulated polyherbal tea and will be used as the control tea. , 20, Placebo Control Group, control group, no dosage, Three months, participants will continue to take normal medication given to them in the hospital and nothing except nutritional education, 20, Uncontrolled
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 04/07/2026 not required Control Group, control group, no dosage, Three months, participants will continue to take normal medication given to them in the hospital and nothing except nutritional education, 20, Uncontrolled Control Group, no placebo treatment, no dosage, Three months, participants will continue to take normal medication given to them in the hospital and nothing except nutritional education, 20, Uncontrolled
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 04/06/2026 Requested to change Experimental Group, PHT, Twice daily (one after breakfast and the other after dinner), Three months, Four commonly used medicinal herbs namely: hibiscus, cinnamon, dandelion and turmeric were bought from Ho market in the Volta region of Ghana. Washed separately with tape thoroughly, then with salt water and finally with distilled water, sliced into pieces and placed on stainless steel trays air-dried in a room under room temperature for 12-14 days. The dried herbs were ground into coarse powder and based on their phytochemicals present, for 2g 40% of hibiscus, 30% of cinnamon, 20% of dandelion and 10% of turmeric were used. the formulated polyherbal tea were placed in tea bags sealed and stored in zip lock bags and stored under room temperature. , 20, Experimental Group, formulated polyherbal tea, Twice daily (one after breakfast and the other after dinner), Three months, Four commonly used medicinal herbs namely: hibiscus, cinnamon, dandelion and turmeric were bought from Ho market in the Volta region of Ghana. Washed separately with tape thoroughly, then with salt water and finally with distilled water, sliced into pieces and placed on stainless steel trays air-dried in a room under room temperature for 12-14 days. The dried herbs were ground into coarse powder and based on their phytochemicals present, for 2g 40% of hibiscus, 30% of cinnamon, 20% of dandelion and 10% of turmeric were used. the formulated polyherbal tea were placed in tea bags sealed and stored in zip lock bags and stored under room temperature. , 20,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 26/06/2026 Requested to change Experimental Group, formulated polyherbal tea, Twice daily (one after breakfast and the other after dinner), Three months, Four commonly used medicinal herbs namely: hibiscus, cinnamon, dandelion and turmeric were bought from Ho market in the Volta region of Ghana. Washed separately with tape thoroughly, then with salt water and finally with distilled water, sliced into pieces and placed on stainless steel trays air-dried in a room under room temperature for 12-14 days. The dried herbs were ground into coarse powder and based on their phytochemicals present, for 2g 40% of hibiscus, 30% of cinnamon, 20% of dandelion and 10% of turmeric were used. the formulated polyherbal tea were placed in tea bags sealed and stored in zip lock bags and stored under room temperature. , 20, Experimental Group, formulated polyherbal tea, Twice daily (one after breakfast and the other after dinner), Three months, participants on normal medication will be given the formulated polyherbal tea and nutritional counselling, 20,
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 14/05/2026 change from capital to small caps Primary Outcome, It is expected that the effectiveness of the polyherbal tea on metabolic syndrome as compared to placebo will be established. , 30DAYS, 60DAYS AND 90DAYS Primary Outcome, It is expected that the effectiveness of the polyherbal tea on metabolic syndrome as compared to placebo will be established. , 30days, 60days and 90days
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 26/06/2026 clearer understanding Primary Outcome, It is expected that the effectiveness of the polyherbal tea on metabolic syndrome as compared to placebo will be established. , 30days, 60days and 90days Primary Outcome, It is expected that the effectiveness of the polyherbal tea on metabolic syndrome in participants on normal medication as compared to control group on medication only will be established. , after every 30days of consuming the tea fasting blood sugar level, blood pressure level and cholesterol level participants for 90days
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 26/06/2026 better explanation Secondary Outcome, It is expected that the safety assessment (acute toxicity test, liver test, kidney test, glycaemic test and lipid profile test) of tea on rats will be determined, 14 days and 28 days Secondary Outcome, It is expected that the safety assessment (acute toxicity test, liver test, kidney test, glycaemic test and lipid profile test) of tea on rats will be determined, rats will be given tea for 14 days to check toxicity of tea and different groups of rats will be given tea, distilled water and green for 28 days for safety assessment
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 14/05/2026 unclear initial upload of ethics letter TRUE, COMMITTEE ON HUMANRESEARCH PUBLICATION AND ETHICS, ROOM7, BLOCK I, SCHOOL OF MEDICINE AND DENTISTRY, KNUST, KUMASI, AK-0308, Ghana, , 14 Apr 2026, +233322063248, chrpe.knust.kath@gmail.com, 41272_38501_4737.pdf TRUE, Committee on Human Research Publication and Ethics, Room7, block I, School of medicine and dentistry, KNUST, Kumasi, AK-0308, Ghana, , 14 Apr 2026, +233322063248, chrpe.knust.kath@gmail.com, 41272_38501_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 15/05/2026 unclear initial upload of ethics letter TRUE, Committee on Human Research Publication and Ethics, Room7, block I, School of medicine and dentistry, KNUST, Kumasi, AK-0308, Ghana, , 14 Apr 2026, +233322063248, chrpe.knust.kath@gmail.com, 41272_38501_4737.pdf TRUE, Committee on Human Research Publication and Ethics, Room7, block I, School of medicine and dentistry, KNUST, Kumasi, AK-0308, Ghana, , 14 Apr 2026, +233322063248, chrpe.knust.kath@gmail.com, 41272_38501_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 26/06/2026 requested for PERSONAL INCOME, P.O.BOX 1362, HO, VOLTA REGION, HO, VH-1660, Ghana, Self Funded, Rira Esi Jones Danso Yeboah, P.O.BOX 1362, HO, VOLTA REGION, HO, VH-1660, Ghana, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 15/05/2026 better answer DATA COLLECTED WILL SOLELY BE USED FOR THIS STUDY AND THE IDENTITY OF PARTICIPANTS WILL NOT BE DISCLOSED TO ANYONE. CONSENT OF PARTICIPANTS WILL BE SORT, QUESTIONS NOT CONVENIENT FOR PARTICIPANTS, HE/SHE HAS THE RIGHT NOT TO RESPOND AND PARTICIPANTS CAN DECIDE TO LEAVE AT ANY TIME All data collected for the study will be coded in order not to disclose the identity of the participants and then shared with anyone who wishes to access the data
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 15/05/2026 capital letter to small caps 6MONTHS -1YEAR 3months -1year after publication
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 15/05/2026 better answer ALL DOCUMENTS WILL BE KEPT WITH MAIN SUPERVISOR AND LOCKED Anyone who wishes to access the data
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD URL 15/05/2026 better answer SPRINGER Springer nature