Diabete MellitusNCT07718880
Nephroprotective Effects of Fig (Ficus Carica L.) Leaf Supplementation
A study testing Intervention group in people with Diabete Mellitus and Diabetic Nephropathy, run by University of Lahore at 1 site in Pakistan.
Trial summary
Diabetic nephropathy is the result of diabetes complications. Excessive blood glucose levels affect several organs which include liver, heart, and kidneys.The aim of this study is to use the nephroprotective and metabolic effects of fig (Ficus carica L.) leaf supplementation with a low glycemic index diet in grade-II… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Diabete Mellitus, Diabetic Nephropathy
- What is being tested?
- Intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Sep 2025to 18 Jan 2026
- Phase
- Interventional
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People within the age range of 35-65 years old adults (both genders)
- Individuals diagnosed with Type 2 diabetes with an HbA1c level between 7-13%
- Diabetics that consume oral hypoglycemic medication
- Participants must have a BMI between 25kg/m2 and 39.9kg/m2
Who cannot join
- Pregnant and lactating women
- Individuals that use insulin therapy apart from medication
- Severe complications like diabetic ketoacidosis
- Individuals with highly restricted diets
- Allergic to latex or figs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nephroprotective Effects of Fig (Ficus Carica L.) Leaf Supplementation in Grade II Chronic Kidney Disease
Diabetic nephropathy is the result of diabetes complications. Excessive blood glucose levels affect several organs which include liver, heart, and kidneys.The aim of this study is to use the nephroprotective and metabolic effects of fig (Ficus carica L.) leaf supplementation with a low glycemic index diet in grade-II chronic kidney disease patients.
Read the detailed description
A pre and post treatment study that evaluated 60 patients (35-65 years old) diagnosed with diabetes and stage 2 chronic kidney disease. Purposive sampling was used to include patients that fit the criteria. The 60 patients selected were randomly divided among two groups: control group and intervention group, each group with 30 patients. Control group patients were given green tea and intervention group patients were given fig leaf tea along with a low glycemic index diet. The tea for both groups was assigned to drink twice a day. The period of this research is 8 weeks. At four weeks , the participants were asked for their feedback. Pre- and post-results were assessed and monitored
- Conditions
- Diabete Mellitus, Diabetic Nephropathy
- Being tested
- Control group, Intervention group
- Keywords
- Diabetic nephropathy, stage 2 chronic kidney disease, diabetic patients, albumin, Fig (Ficus carica L.) leaves
- Medical subject headings
- Diabetes Mellitus, Diabetic Nephropathies, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupDietary supplement
Participants were guided to make Jasmine Green tea by boiling 200ml of water and add tea bag twice a day
Intervention groupDietary supplement
Participants were advised to take Fig leaf tea (200ml/tea bag) twice a day for 8 weeks. Low glycemic index diet plan was also followed.
| Study group | Role | What they receive |
|---|---|---|
| Control group on Green Tea | Active comparator | Participants were advised to take Jasmine Green tea (200ml/tea bag). Receives: Dietary Supplement: Control group |
| Intervention group on Fig tea | Experimental | Participants were advised to take Fig leaf tea (200ml/tea bag) twice a day for 8 weeks along with low glycemic index diet. Receives: Dietary Supplement: Intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index
Body mass index (BMI) is a universally utilized anthropometric screening tool that is used to assess a person's health by evaluating their obesity and nutritional status, applies for both males and females. For body mass index weight in kg and height in meters squared, were used to calculate changes in body size.
Measured: 8 weeks
Fasting blood glucose (FBG)
Fasting blood glucose (FBG) is a simple test that measures a person's blood sugar level after fasting for approximately 8-12 hours. This test determines the amount of glucose present on an empty stomach to understand the baseline of glucose levels. A glucometer is used to measure FBG. The unit for FBG is mg/dL. For this study the range to determine stage 2 diabetic kidney damage is approximately 120 - 300 mg/dL.
Measured: 8 weeks
Lipid profile
Lipid profile is a key blood-based biomarker that measures the amount of lipid present in the blood of a person. The key components of lipid profile we will use are triglycerides, total cholesterol, low density lipoprotein (LDL), and high density lipo-protein (HDL). These components are used to detect any unnecessary amount of lipids present in the blood for early detection of health issues. Triglycerides are the storage form of lipid. Total cholesterol is the overall amount of lipid components. LDL also known as "bad" cholesterol accumulates in blood causing problems in bloodstream. HDL also known as "good" cholesterol reduces amounts of LDL cholesterol in blood. The unit used is mg/dL (L. Wang et al., 2022). In this study the ranges used to determine stage 2 diabetic kidney damage are: triglycerides (150 - 290mg/dl), total cholesterol (160 - 300 mg/dl), LDL (130 - 190 mg/dl), and HDL (20 - 50 mg/dl).
Measured: 8 weeks
Renal function tests
Renal function tests (RFT) take place to evaluate the functionality of kidneys and if they properly filter waste. Blood and urine samples are taken, and serum creatinine and blood urea nitrogen (BUN) are tests that detect possible kidney damage or disease. For diabetics diagnosis of kidney damage as early as possible is essential for treatment (Gounden, Bhatt, \& Jialal, 2024). In this study the ranges used to determine Stage 2 diabetic kidney damage are: serum creatinine (1.05 - 2.0 mg/dl), and blood urea nitrogen (20 - 46 mg/dl).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start18 Sep 2025
- Primary completion18 Nov 2025
- Study completion18 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Aslam, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718880
- Sponsor's protocol ID
- IRB-UOL-FAHS/409/2025
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nephroprotective Effects of Fig (Ficus Carica L.) Leaf Supplementation in Grade II Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT07718880
- Acronym / sponsor ID
- IRB-UOL-FAHS/409/2025
- Conditions
- Diabete Mellitus, Diabetic Nephropathy
- Keywords
- Diabetic nephropathy, stage 2 chronic kidney disease, diabetic patients, albumin, Fig (Ficus carica L.) leaves
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 18 Jan 2026 (actual)
- First posted
- 22 Jul 2026 (actual)
- 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.
Diabetic nephropathy is the result of diabetes complications. Excessive blood glucose levels affect several organs which include liver, heart, and kidneys.The aim of this study is to use the nephroprotective and metabolic effects of fig (Ficus carica L.) leaf supplementation with a low glycemic index diet in grade-II chronic kidney disease patients.
Detailed description
A pre and post treatment study that evaluated 60 patients (35-65 years old) diagnosed with diabetes and stage 2 chronic kidney disease. Purposive sampling was used to include patients that fit the criteria. The 60 patients selected were randomly divided among two groups: control group and intervention group, each group with 30 patients. Control group patients were given green tea and intervention group patients were given fig leaf tea along with a low glycemic index diet. The tea for both groups was assigned to drink twice a day. The period of this research is 8 weeks. At four weeks , the participants were asked for their feedback. Pre- and post-results were assessed and monitored
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group on Green Tea | Active comparator | Dietary Supplement: Control groupParticipants were advised to take Jasmine Green tea (200ml/tea bag). |
| Intervention group on Fig tea | Experimental | Dietary Supplement: Intervention groupParticipants were advised to take Fig leaf tea (200ml/tea bag) twice a day for 8 weeks along with low glycemic index diet. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- People within the age range of 35-65 years old adults (both genders)
- Individuals diagnosed with Type 2 diabetes with an HbA1c level between 7-13%
- Diabetics that consume oral hypoglycemic medication
- Participants must have a BMI between 25kg/m2 and 39.9kg/m2
Key exclusion criteria (5 listed)
- Pregnant and lactating women
- Individuals that use insulin therapy apart from medication
- Severe complications like diabetic ketoacidosis
- Individuals with highly restricted diets
- Allergic to latex or figs.
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 |
|---|---|---|
| Control groupParticipants were guided to make Jasmine Green tea by boiling 200ml of water and add tea bag twice a day | Dietary supplement | Control group on Green Tea |
| Intervention groupParticipants were advised to take Fig leaf tea (200ml/tea bag) twice a day for 8 weeks. Low glycemic index diet plan was also followed. | Dietary supplement | Intervention group on Fig tea |
Primary outcome
Body Mass Index
Time frame: 8 weeks
Body mass index (BMI) is a universally utilized anthropometric screening tool that is used to assess a person's health by evaluating their obesity and nutritional status, applies for both males and females. For body mass index weight in kg and height in meters squared, were used to calculate changes in body size.
Fasting blood glucose (FBG)
Time frame: 8 weeks
Fasting blood glucose (FBG) is a simple test that measures a person's blood sugar level after fasting for approximately 8-12 hours. This test determines the amount of glucose present on an empty stomach to understand the baseline of glucose levels. A glucometer is used to measure FBG. The unit for FBG is mg/dL. For this study the range to determine stage 2 diabetic kidney damage is approximately 120 - 300 mg/dL.
Lipid profile
Time frame: 8 weeks
Lipid profile is a key blood-based biomarker that measures the amount of lipid present in the blood of a person. The key components of lipid profile we will use are triglycerides, total cholesterol, low density lipoprotein (LDL), and high density lipo-protein (HDL). These components are used to detect any unnecessary amount of lipids present in the blood for early detection of health issues. Triglycerides are the storage form of lipid. Total cholesterol is the overall amount of lipid components. LDL also known as "bad" cholesterol accumulates in blood causing problems in bloodstream. HDL also known as "good" cholesterol reduces amounts of LDL cholesterol in blood. The unit used is mg/dL (L. Wang et al., 2022). In this study the ranges used to determine stage 2 diabetic kidney damage are: triglycerides (150 - 290mg/dl), total cholesterol (160 - 300 mg/dl), LDL (130 - 190 mg/dl), and HDL (20 - 50 mg/dl).
Renal function tests
Time frame: 8 weeks
Renal function tests (RFT) take place to evaluate the functionality of kidneys and if they properly filter waste. Blood and urine samples are taken, and serum creatinine and blood urea nitrogen (BUN) are tests that detect possible kidney damage or disease. For diabetics diagnosis of kidney damage as early as possible is essential for treatment (Gounden, Bhatt, \& Jialal, 2024). In this study the ranges used to determine Stage 2 diabetic kidney damage are: serum creatinine (1.05 - 2.0 mg/dl), and blood urea nitrogen (20 - 46 mg/dl).
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 22 Jul 2026.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Diabete Mellitus and Diabetic Nephropathy, run by University of Lahore at 1 site in Pakistan.
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 4 inclusion and 5 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 22 Jul 2026. 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 Pakistan. 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.
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?
Body Mass Index (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2026.