Type2 Diabetes MellitusNCT05343767
Investigate the Efficacy and Safety of Low-Glu in Patients Newly Diagnosed With Type II Diabetes Mellitus
A study testing Natural Wellness Low-Glu low dose, Natural Wellness Low-Glu high dose and Metformin in people with Type2 Diabetes Mellitus, run by Natural Wellness Egypt at 1 site in Egypt.
Trial summary
Ficus deltoidea leaves, Cinnamomum cassia and Black seed powdered extract have long been used for the treatment of type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- Natural Wellness Low-Glu low dose, Natural Wellness Low-Glu high dose and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Sep 2018to 30 May 2021
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to provide written informed consent.
- Males and females aged between 18 and 65 years of age.
- Newly diagnosed with type II diabetes mellitus patients as per the following criteria (FBG ≥ 126 mg/dl) or, 2h- post prandial ≥ 200 mg/dl during OGTT or, HbA1c ≥ 6.5%
- Anti-diabetic treatment naïve patients.
- Able and willing to perform SMBG and to complete subject diaries.
Who cannot join
- Pregnant or lactating women; women of childbearing potential must agree to use an accepted method of contraception during the course of the study and for 1 month after their last dose of study drug.
- Patients with BMI > 40 Kg/m2 or BMI < 18.5 Kg/m2.
- eGFR <60 mL/min/1.73 m2 (measured by the CKD-EPI equation) 3.
- History of Positive human immunodeficiency virus, hepatitis B surface antigen (HBsAG), or hepatitis C antibody test.
- History of type I diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes such as Cushing's syndrome or acromegaly.
- History of diabetic complications such as diabetic ketoacidosis, lactic acidosis or state of hyperosmolar hyperglycemia, diabetic proliferative retinopathy, or severe diabetic neuropathy (requiring treatment with antidepressants or opioids) and history of decompensated diabetes (polyuria, polydipsia, nocturia, fatigue).
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- History of chronic gastrointestinal (GI) conditions that could impede gastric emptying or potentially affect the interpretation of the study data.
- History of weight loss surgery or weight loss procedure involving the GI tract, such as gastric bypass, gastric stapling, or gastric banding.
- History of an eating disorder (e.g., bulimia, anorexia).
- History of malignancy (except treated basal or squamous cell skin cancer) within 5 years prior to screening.
- History of significant cardiovascular disease (such as congestive heart failure, myocardial infarction, coronary disease) or uncontrolled hypertension.
- History of clinically significant renal or liver disease.
- Receipt of an investigational drug within 30 days prior to screening, or active enrollment in another investigational medication or device trial.
- Known or suspected allergy to the trial products.
- Any condition, in the judgment of the investigator, that would interfere with the patient's ability to comply with all study requirements or that would place the patient at unacceptable risk by his/her participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Randomized, Double Blind, Double Dummy, Active-Controlled Clinical Trial to Investigate the Efficacy and Safety of Low-Glu in Patients Newly Diagnosed With Type II Diabetes Mellitus
Ficus deltoidea leaves, Cinnamomum cassia and Black seed powdered extract have long been used for the treatment of type 2 diabetes mellitus.
Read the detailed description
Diabetes Mellitus (DM), commonly referred to as Diabetes is defined by World Health Organization (WHO) as a group of metabolic disorders characterized by chronic Hyperglycemia resulting from defects in insulin secretion, insulin action or both. Long-term organ damage, organ dysfunction and organ failure are associated with the chronic Hyperglycemia of Diabetes. Possible Diabetes complications can be classified into two major categories; macrovascular and microvascular including Ischemic Heart Disease (IHD), Peripheral Vascular Disease (PVD), and Cerebrovascular Disease (CVD) "macrovascular", and Nephropathy, Retinopathy, and Neuropathy "microvascular" resulting in organ and tissue damage in almost one third to one half of population with diabetes.
According to the International Diabetes Federation (IDF), the three main types of Diabetes are Type 1 Diabetes, Type 2 Diabetes and Gestational Diabetes. Type 1 DM, formerly described as "Insulin Dependent Diabetes Mellitus" (IDDM) results from β-cells destruction, usually leading to absolute deficiency of insulin. Type 2 DM formerly described as "Non-Insulin-Dependent Diabetes Mellitus" (NIDDM) results from a progressive insulin secretory defect on the background of insulin resistance. Gestational Diabetes, which appears during pregnancy, is associated with increasing the risk of developing type 2 Diabetes in both mother and child later in life.
Diabetes is a rapidly growing health concern in both developed and developing nations and its prevalence is continuously increasing worldwide. Globally, in 2014, approximately 422 million adults were having diabetes, with type 2 making up about 91%of the cases. In 2015, according to IDF, an estimated 415 million adults were having diabetes along with an estimated 318 million adults with impaired glucose tolerance. Both WHO and IDF predict that by 2030, this number will be doubled. In 2016 the WHO global report on Diabetes stated that the prevalence of Diabetes has increased faster in low- and middle-income countries than in high-income countries.
Type 2 Diabetes is characterized by insulin resistance and/or abnormal insulin secretion, either of which may predominate. It is associated with several metabolic defects such as obesity, hypertension, and dyslipidemia, which contribute to the very high rate of cardiovascular morbidity and mortality.
Medicinal herbs were used to treat a wide range of diseases long time before the birth of conventional medicine systems. The World Health Organization (WHO) has listed 21,000 plant names, which are used for medicinal purposes around the world, so despite the fact that medicinal herbs are at times misconceived as being unscientific, their continual existence proves they are able to be alternatives or complementary to conventional drugs at some point.
Specifically, Ficus deltoidea leaves, Cinnamomum cassia L. powdered Extract and Black seed powdered extract have been used for the treatment of Diabetes Mellitus and other medical conditions for over 2000 years. Ficus deltoidea is an evergreen shrub reaching to 2 meters of height, with whitish grey bark, broadly spoon-shaped to obovate leaves and spherical or round figs. Over the years, it has been used to treat many diseases such as; Diabetes Mellitus, Hypertension, Hyperlipidemia and Gout. Numerous studies were conducted over the past years to assess the safety of Ficus deltoidea, Cinnamomum cassia L. powdered extract and Black seed powdered extract and their efficacy in treating type 2 Diabetes Mellitus.
As the available data on NW Low-Glu efficacy, safety and dosing regimen is not enough, this study will be conducted to compare the hypoglycemic effect of two doses of a herbal medicinal product of ficus and Cinnamomum cassia L. powdered Extract + Black seed powdered extract (NW Low-Glu) to that of Metformin as measured by the mean change in HbA1c levels in patients newly diagnosed with type II diabetes mellitus.
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- Natural Wellness Low-Glu low dose, Natural Wellness Low-Glu high dose, Metformin
- Keywords
- Ficus deltoidea, HbA1c, weight, metabolic syndrome, medicinal plants
- Medical subject headings
- Body Weight, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural Wellness Low-Glu low doseDietary supplement
Also called Mas Cotek powdered Extract 300 mg + Cinnamomum cassia L. powdered Extract 100 mg + Black seed powdered extract 250 mg
The contents of 4 capsules of NW Low-Glu were equally distributed and inserted into 6 capsules size 0, and administered in 3 daily doses
Natural Wellness Low-Glu high doseDietary supplement
The contents of 5 capsules of NW Low-Glu were equally distributed and inserted into 6 capsules size 0, and administered in 3 daily doses
MetforminOther
A total dose of 2000 mg was administered per day.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm 1 Metformin ( 64 patients) | Active comparator | Metformin 1000 mg tablets were used.
* First Dose: One Metformin 1000 mg tablet + Two Placebo Capsules administered PO on empty stomach with plenty of water 2 hours after meals.
* Second Dose: Two Placebo Capsules administered PO on empty stomach with plenty of water 2 hours after meals.
* Third Dose: One Metformin 1000 mg tablet + Two Placebo Capsules administered PO on empty stomach with plenty of water 2 hours after meals.
A total dose of 2000 mg was administered per day. Receives: Other: Metformin |
| Experimental Arm 2: Low Dose NW Low-Glu ( 65 patients) | Experimental | The contents of 4 capsules of NW Low-Glu were equally distributed and inserted into 6 capsules size 0, and administered in 3 daily doses as follows:
* First Dose: One Placebo tablet + Two size 0 NW Low-Glu Capsules administered PO on empty stomach with plenty of water 2 hours after meals.
* Second Dose: Two size 0 NW Low-Glu Capsules administered PO on empty stomach with plenty of water 2 hours after meals.
* Third Dose: One Placebo tablet + Two size 0 NW Low-Glu Capsules administered PO on empty stomach with plenty of water 2 hours after meals. Receives: Dietary Supplement: Natural Wellness Low-Glu low dose |
| Experimental Arm 3: High Dose NW Low-Glu ( 69 patients) | Experimental | The contents of 5 capsules of NW Low-Glu were equally distributed and inserted into 6 capsules size 0, and administered in 3 daily doses as follows:
* First Dose: One Placebo tablet + Two size 0 NW Low-Glu Capsules administered PO on empty stomach with plenty of water 2 hours after meals.
* Second Dose: Two size 0 NW Low-Glu Capsules administered PO on empty stomach with plenty of water 2 hours after meals.
* Third Dose: One Placebo tablet + Two size 0 NW Low-Glu Capsules administered PO on empty stomach with plenty of water 2 hours after meals. Receives: Dietary Supplement: Natural Wellness Low-Glu high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the hypoglycemic effect of two doses of a herbal medicinal product (NW Low-Glu) to that of Metformin as measured by the mean change in HbA1c levels in patients newly diagnosed with type II diabetes mellitus.
Comparing the mean change in HbA1c levels between each experimental arm and active-control arm
Measured: 12 weeks
Secondary outcomes (2)
To measure the incidence of hypoglycemia events and other adverse events in patients newly diagnosed with type II diabetes mellitus (Safety)
Comparing the mean change in fasting plasma glucose levels between each experimental arm and active-control arm
Measured: 12 weeks
To compare the mean change in the 2h-post prandial glucose levels between each experimental arm and active-control arm (efficacy)
To compare the mean change in the 2h-post prandial glucose levels between each experimental arm and active-control arm.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start12 Sep 2018
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a double-blind, double dummy, randomized, active-controlled, three-arm, parallel-group, interventional phase II clinical trial to investigate efficacy and safety of a herbal medicinal product of (NW Low-Glu) in patients newly diagnosed with type II diabetes mellitus. Study duration: 3 months of recruitment and 3 months of treatment. Sample Size: It was planned to enroll 68 patients per arm, 204 in total. Participants were patients between 18 and 65 years of age, newly diagnosed with type II diabetes mellitus and consenting to participate in this study. Eligible patients were randomized in a 1:1:1 allocation ratio, into one of the three treatment groups, to receive either Metformin or one of the two doses of NW Low-Glu.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natural Wellness Egypt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Dr Samir Helmy Assaad, MD, Principal investigator, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343767
- Sponsor's protocol ID
- NW_Low-Glu_14122016
- Status last verified
- Apr 2022
- First submitted
- 10 Apr 2022
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cade WT. Diabetes-related microvascular and macrovascular diseases in the physical therapy setting. Phys Ther. 2008 Nov;88(11):1322-35. doi: 10.2522/ptj.20080008. Epub 2008 Sep 18.
PubMed 18801863Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998 Jul;15(7):539-53. doi: 10.1002/(SICI)1096-9136(199807)15:73.0.CO;2-S.
PubMed 9686693IDF. IDF Diabetes Atlas · Seventh Edition. 2015.
WHO. Global report on diabetes. 2016.
Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010 Jan;87(1):4-14. doi: 10.1016/j.diabres.2009.10.007. Epub 2009 Nov 6.
PubMed 19896746Zimmet P, Alberti KG, Shaw J. Global and societal implications of the diabetes epidemic. Nature. 2001 Dec 13;414(6865):782-7. doi: 10.1038/414782a.
PubMed 11742409Edelman SV. Type II diabetes mellitus. Adv Intern Med. 1998;43:449-500.
PubMed 9506190Pan SY, Pan S, Yu ZL, Ma DL, Chen SB, Fong WF, Han YF, Ko KM. New perspectives on innovative drug discovery: an overview. J Pharm Pharm Sci. 2010;13(3):450-71. doi: 10.18433/j39w2g.
PubMed 21092716Bamosa A, Kaatabi H, Badar A, Al-Khadra A, Al Elq A, Abou-Hozaifa B, Lebda F, Al-Almaie S. Nigella sativa: A potential natural protective agent against cardiac dysfunction in patients with type 2 diabetes mellitus. J Family Community Med. 2015 May-Aug;22(2):88-95. doi: 10.4103/2230-8229.155380.
PubMed 25983604Jia Q, Liu X, Wu X, Wang R, Hu X, Li Y, Huang C. Hypoglycemic activity of a polyphenolic oligomer-rich extract of Cinnamomum parthenoxylon bark in normal and streptozotocin-induced diabetic rats. Phytomedicine. 2009 Aug;16(8):744-50. doi: 10.1016/j.phymed.2008.12.012. Epub 2009 May 22.
PubMed 19464860Corner E. The complex of Fixcus Deltoidea ; A recent invasion of the sunda shelf. Philos Trans R Soc London B, Biol Sci. 1969 Nov;256(808):281-317.
Hakiman M, Maziah M. Non enzymatic and enzymatic antioxidant activities in aqueous extract of different Ficus deltoidea accessions. J Med Plants Res. 2009;3(3):120-31.
Sulaiman MR, Hussain MK, Zakaria ZA, Somchit MN, Moin S, Mohamad AS, Israf DA. Evaluation of the antinociceptive activity of Ficus deltoidea aqueous extract. Fitoterapia. 2008 Dec;79(7-8):557-61. doi: 10.1016/j.fitote.2008.06.005. Epub 2008 Jul 10.
PubMed 18672036Prakash B, Singh P, Yadav S, Singh SC, Dubey NK. Safety profile assessment and efficacy of chemically characterized Cinnamomum glaucescens essential oil against storage fungi, insect, aflatoxin secretion and as antioxidant. Food Chem Toxicol. 2013 Mar;53:160-7. doi: 10.1016/j.fct.2012.11.044. Epub 2012 Dec 5.
PubMed 23220615Tauseef Sultan M, Butt MS, Anjum FM. Safety assessment of black cumin fixed and essential oil in normal Sprague Dawley rats: Serological and hematological indices. Food Chem Toxicol. 2009 Nov;47(11):2768-75. doi: 10.1016/j.fct.2009.08.011. Epub 2009 Aug 21.
PubMed 19699773
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double Blind, Double Dummy, Active-Controlled Clinical Trial to Investigate the Efficacy and Safety of Low-Glu in Patients Newly Diagnosed With Type II Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05343767
- Acronym / sponsor ID
- NW_Low-Glu_14122016
- Conditions
- Type2 Diabetes Mellitus
- Keywords
- Ficus deltoidea, HbA1c, weight, metabolic syndrome, medicinal plants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Natural Wellness EgyptIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2018 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 25 Apr 2022 (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.
Ficus deltoidea leaves, Cinnamomum cassia and Black seed powdered extract have long been used for the treatment of type 2 diabetes mellitus.
Detailed description
Diabetes Mellitus (DM), commonly referred to as Diabetes is defined by World Health Organization (WHO) as a group of metabolic disorders characterized by chronic Hyperglycemia resulting from defects in insulin secretion, insulin action or both. Long-term organ damage, organ dysfunction and organ failure are associated with the chronic Hyperglycemia of Diabetes. Possible Diabetes complications can be classified into two major categories; macrovascular and microvascular including Ischemic Heart Disease (IHD), Peripheral Vascular Disease (PVD), and Cerebrovascular Disease (CVD) "macrovascular", and Nephropathy, Retinopathy, and Neuropathy "microvascular" resulting in organ and tissue damage in almost one third to one half of population with diabetes.
According to the International Diabetes Federation (IDF), the three main types of Diabetes are Type 1 Diabetes, Type 2 Diabetes and Gestational Diabetes. Type 1 DM, formerly described as "Insulin Dependent Diabetes Mellitus" (IDDM) results from β-cells destruction, usually leading to absolute deficiency of insulin. Type 2 DM formerly described as "Non-Insulin-Dependent Diabetes Mellitus" (NIDDM) results from a progressive insulin secretory defect on the background of insulin resistance. Gestational Diabetes, which appears during pregnancy, is associated with increasing the risk of developing type 2 Diabetes in both mother and child later in life.
Diabetes is a rapidly growing health concern in both developed and developing nations and its prevalence is continuously increasing worldwide. Globally, in 2014, approximately 422 million adults were having diabetes, with type 2 making up about 91%of the cases. In 2015, according to IDF, an estimated 415 million adults were having diabetes along with an estimated 318 million adults with impaired glucose tolerance. Both WHO and IDF predict that by 2030, this number will be doubled. In 2016 the WHO global report on Diabetes stated that the prevalence of Diabetes has increased faster in low- and middle-income countries than in high-income countries.
Type 2 Diabetes is characterized by insulin resistance and/or abnormal insulin secretion, either of which may predominate. It is associated with several metabolic defects such as obesity, hypertension, and dyslipidemia, which contribute to the very high rate of cardiovascular morbidity and mortality.
Medicinal herbs were used to treat a wide range of diseases long time before the birth of conventional medicine systems. The World Health Organization (WHO) has listed 21,000 plant names, which are used for medicinal purposes around the world, so despite the fact that medicinal herbs are at times misconceived as being unscientific, their continual existence proves they are able to be alternatives or complementary to conventional drugs at some point.
Specifically, Ficus deltoidea leaves, Cinnamomum cassia L. powdered Extract and Black seed powdered extract have been used for the treatment of Diabetes Mellitus and other medical conditions for over 2000 years. Ficus deltoidea is an evergreen shrub reaching to 2 meters of height, with whitish grey bark, broadly spoon-shaped to obovate leaves and spherical or round figs. Over the years, it has been used to treat many diseases such as; Diabetes Mellitus, Hypertension, Hyperlipidemia and Gout. Numerous studies were conducted over the past years to assess the safety of Ficus deltoidea, Cinnamomum cassia L. powdered extract and Black seed powdered extract and their efficacy in treating type 2 Diabetes Mellitus.
As the available data on NW Low-Glu efficacy, safety and dosing regimen is not enough, this study will be conducted to compare the hypoglycemic effect of two doses of a herbal medicinal product of ficus and Cinnamomum cassia L. powdered Extract + Black seed powdered extract (NW Low-Glu) to that of Metformin as measured by the mean change in HbA1c levels in patients newly diagnosed with type II diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This was a double-blind, double dummy, randomized, active-controlled, three-arm, parallel-group, interventional phase II clinical trial to investigate efficacy and safety of a herbal medicinal product of (NW Low-Glu) in patients newly diagnosed with type II diabetes mellitus. Study duration: 3 months of recruitment and 3 months of treatment. Sample Size: It was planned to enroll 68 patients per arm, 204 in total. Participants were patients between 18 and 65 years of age, newly diagnosed with type II diabetes mellitus and consenting to participate in this study. Eligible patients were randomized in a 1:1:1 allocation ratio, into one of the three treatment groups, to receive either Metformin or one of the two doses of NW Low-Glu.
| Arm | Type | Receives |
|---|---|---|
| Control Arm 1 Metformin ( 64 patients) | Active comparator | Other: MetforminMetformin 1000 mg tablets were used. * First Dose: One Metformin 1000 mg tablet + Two Placebo Capsules administered PO on empty stomach with plenty of water 2 hours after meals. * Second Dose: Two Placebo Capsules administered PO on empty stomach with plenty of water 2 hours after meals. * Third Dose: One Metformin 1000 mg tablet + Two Placebo Capsules administered PO on empty stomach with plenty of water 2 hours after meals. A total dose of 2000 mg was administered per day. |
| Experimental Arm 2: Low Dose NW Low-Glu ( 65 patients) | Experimental | Dietary Supplement: Natural Wellness Low-Glu low doseThe contents of 4 capsules of NW Low-Glu were equally distributed and inserted into 6 capsules size 0, and administered in 3 daily doses as follows: * First Dose: One Placebo tablet + Two size 0 NW Low-Glu Capsules administered PO on empty stomach with plenty of water 2 hours after meals. * Second Dose: Two size 0 NW Low-Glu Capsules administered PO on empty stomach with plenty of water 2 hours after meals. * Third Dose: One Placebo tablet + Two size 0 NW Low-Glu Capsules administered PO on empty stomach with plenty of water 2 hours after meals. |
| Experimental Arm 3: High Dose NW Low-Glu ( 69 patients) | Experimental | Dietary Supplement: Natural Wellness Low-Glu high doseThe contents of 5 capsules of NW Low-Glu were equally distributed and inserted into 6 capsules size 0, and administered in 3 daily doses as follows: * First Dose: One Placebo tablet + Two size 0 NW Low-Glu Capsules administered PO on empty stomach with plenty of water 2 hours after meals. * Second Dose: Two size 0 NW Low-Glu Capsules administered PO on empty stomach with plenty of water 2 hours after meals. * Third Dose: One Placebo tablet + Two size 0 NW Low-Glu Capsules administered PO on empty stomach with plenty of water 2 hours after meals. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able and willing to provide written informed consent.
- Males and females aged between 18 and 65 years of age.
- Newly diagnosed with type II diabetes mellitus patients as per the following criteria (FBG ≥ 126 mg/dl) or, 2h- post prandial ≥ 200 mg/dl during OGTT or, HbA1c ≥ 6.5%
- Anti-diabetic treatment naïve patients.
- Able and willing to perform SMBG and to complete subject diaries.
Key exclusion criteria (15 listed)
- Pregnant or lactating women; women of childbearing potential must agree to use an accepted method of contraception during the course of the study and for 1 month after their last dose of study drug.
- Patients with BMI > 40 Kg/m2 or BMI < 18.5 Kg/m2.
- eGFR <60 mL/min/1.73 m2 (measured by the CKD-EPI equation) 3.
- History of Positive human immunodeficiency virus, hepatitis B surface antigen (HBsAG), or hepatitis C antibody test.
- History of type I diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes such as Cushing's syndrome or acromegaly.
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 |
|---|---|---|
| Natural Wellness Low-Glu low doseAlso: Mas Cotek powdered Extract 300 mg + Cinnamomum cassia L. powdered Extract 100 mg + Black seed powdered extract 250 mgThe contents of 4 capsules of NW Low-Glu were equally distributed and inserted into 6 capsules size 0, and administered in 3 daily doses | Dietary supplement | Experimental Arm 2: Low Dose NW Low-Glu ( 65 patients) |
| Natural Wellness Low-Glu high doseThe contents of 5 capsules of NW Low-Glu were equally distributed and inserted into 6 capsules size 0, and administered in 3 daily doses | Dietary supplement | Experimental Arm 3: High Dose NW Low-Glu ( 69 patients) |
| MetforminA total dose of 2000 mg was administered per day. | Other | Control Arm 1 Metformin ( 64 patients) |
Primary outcome
To compare the hypoglycemic effect of two doses of a herbal medicinal product (NW Low-Glu) to that of Metformin as measured by the mean change in HbA1c levels in patients newly diagnosed with type II diabetes mellitus.
Time frame: 12 weeks
Comparing the mean change in HbA1c levels between each experimental arm and active-control arm
2 secondary outcomes
To measure the incidence of hypoglycemia events and other adverse events in patients newly diagnosed with type II diabetes mellitus (Safety)
Time frame: 12 weeks
To compare the mean change in the 2h-post prandial glucose levels between each experimental arm and active-control arm (efficacy)
Time frame: 12 weeks
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 3 May 2022.
- Background: PubMed 18801863Cade WT. Diabetes-related microvascular and macrovascular diseases in the physical therapy setting. Phys Ther. 2008 Nov;88(11):1322-35. doi: 10.2522/ptj.20080008. Epub 2008 Sep 18.
- Background: PubMed 9686693Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998 Jul;15(7):539-53. doi: 10.1002/(SICI)1096-9136(199807)15:73.0.CO;2-S.
- BackgroundIDF. IDF Diabetes Atlas · Seventh Edition. 2015.
- BackgroundWHO. Global report on diabetes. 2016.
- Background: PubMed 19896746Shaw JE, Sicree RA, Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010 Jan;87(1):4-14. doi: 10.1016/j.diabres.2009.10.007. Epub 2009 Nov 6.
- Background: PubMed 11742409Zimmet P, Alberti KG, Shaw J. Global and societal implications of the diabetes epidemic. Nature. 2001 Dec 13;414(6865):782-7. doi: 10.1038/414782a.
- Background: PubMed 9506190Edelman SV. Type II diabetes mellitus. Adv Intern Med. 1998;43:449-500.
- Background: PubMed 21092716Pan SY, Pan S, Yu ZL, Ma DL, Chen SB, Fong WF, Han YF, Ko KM. New perspectives on innovative drug discovery: an overview. J Pharm Pharm Sci. 2010;13(3):450-71. doi: 10.18433/j39w2g.
- Background: PubMed 25983604Bamosa A, Kaatabi H, Badar A, Al-Khadra A, Al Elq A, Abou-Hozaifa B, Lebda F, Al-Almaie S. Nigella sativa: A potential natural protective agent against cardiac dysfunction in patients with type 2 diabetes mellitus. J Family Community Med. 2015 May-Aug;22(2):88-95. doi: 10.4103/2230-8229.155380.
- Background: PubMed 19464860Jia Q, Liu X, Wu X, Wang R, Hu X, Li Y, Huang C. Hypoglycemic activity of a polyphenolic oligomer-rich extract of Cinnamomum parthenoxylon bark in normal and streptozotocin-induced diabetic rats. Phytomedicine. 2009 Aug;16(8):744-50. doi: 10.1016/j.phymed.2008.12.012. Epub 2009 May 22.
- BackgroundCorner E. The complex of Fixcus Deltoidea ; A recent invasion of the sunda shelf. Philos Trans R Soc London B, Biol Sci. 1969 Nov;256(808):281-317.
- BackgroundHakiman M, Maziah M. Non enzymatic and enzymatic antioxidant activities in aqueous extract of different Ficus deltoidea accessions. J Med Plants Res. 2009;3(3):120-31.
- Individual participant dataSharing planned: No
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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.
Prof. Dr Samir Helmy Assaad, MD principal investigator
University of Alexandria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natural Wellness Low-Glu low dose, Natural Wellness Low-Glu high dose and Metformin in people with Type2 Diabetes Mellitus, run by Natural Wellness Egypt at 1 site in Egypt.
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 5 inclusion and 15 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 3 May 2022. 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 Egypt. 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?
To compare the hypoglycemic effect of two doses of a herbal medicinal product (NW Low-Glu) to that of Metformin as measured by the mean change in HbA1c levels in patients newly diagnosed with type II diabetes mellitus. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05343767, which also lists 27 linked publications.
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 3 May 2022.