A randomized, double-blind, parallel-arm clinical trial to assess the efficacy and safety of a Health supplement (Antox-D liquid) in participants with type 2 diabetes mellitus.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 1. Assessment of changes in HbA1c levels and Fasting and post-meal plasma glucose will be done
研究概览
简要总结
Type 2 Diabetes Mellitus is a chronic metabolic disorder characterized by insulin resistance, impaired insulin secretion, and elevated blood glucose levels. It presents a significant global health burden due to its associated complications, such as cardiovascular disease, nephropathy, neuropathy, and retinopathy. While pharmacologic and lifestyle interventions are standard, limitations related to side effects, cost, and adherence have driven interest in safe, adjunctive nutraceutical options.
Antox-D is a liquid nutraceutical formulation comprising FSSAI-approved botanical extracts including Momordica charantia (Karela), Syzygium cuminii (Jamun), Trigonella foenum-graecum (Methi), Withania somnifera (Ashwagandha), Aegle marmelos (Bael), and others. These components are supported by traditional use and emerging evidence for their antidiabetic, lipid-lowering, antioxidant, and anti-inflammatory properties. Potential benefits of Antox-D include reductions in fasting and postprandial glucose, HbA1c, reduced reliance on allopathic medication, and improved quality of life. However, these observations require validation through a well-designed clinical trial.
Pharmacologically, Antox-D’s ingredients exert complementary effects:
Karela enhances insulin secretion and mimics insulin action.
Jamun and Methi improve glycemic and lipid profiles.
Bael offers nephroprotective and anti-glycation effects.
Ashwagandha, Neem, and Triphala contribute neuroprotective, immunomodulatory, and detoxifying actions.
This study aims to evaluate the clinical efficacy and safety of Antox-D in T2DM individuals, assessing its impact on glycemic control, metabolic markers, and quality of life. Mechanistic insights from parallel in vitro studies will help rationalize observed outcomes and define its therapeutic potential.
Rationale for Dosing Interval – Investigational Product & OHA
Evidence suggests that certain phytoconstituent may modulate the pharmacokinetics and pharmacodynamics of oral hypoglycemic agents. Specifically, Gymnema sylvestre has been reported to reduce the bioavailability of metformin, whereas Momordica charantia (Karela) may potentiate its antihyperglycemic activity. Additionally, Azadirachta indica (Neem) and Zingiber officinale (Ginger) may antagonize the glucose-lowering effects of glibenclamide, while Trigonella foenum-graecum (Methi) and Syzygium cumini (Jamun) have been shown to prolong the action of gliclazide.
In light of these potential herb-drug interactions, the investigational product will be administered at least one hour prior to food intake to minimize the risk of altered glycemic control. As oral hypoglycemic agents (e.g., biguanides and sulfonylureas) are typically administered with or after meals, this dosing strategy ensures temporal separation, thereby reducing the likelihood of interaction-related hypoglycemic or hyperglycemic events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female participants aged between 30 and 65 years (both inclusive)
- •Participants receiving oral hypoglycemic agents, biguanides, and sulfonylureas (Only combination)
- •Glycated hemoglobin (HbA1c) greater than 7% and less than 9 % ( both inclusive)
- •Participants with a BMI of less than 30 kg/m2.
排除标准
- •Participant with Type 1 diabetes mellitus;
- •Participant taking antidiabetic drugs except for those specified in the inclusion criteria, including Insulin treatment;
- •Participants with concurrent serious hepatic dysfunction (defined as AST and/or ALT more than 3 times the upper normal limit) or renal dysfunction (defined as S.
- •creatinine greater than 1.4 mg/dl), uncontrolled pulmonary dysfunction (asthmatic and COPD patients), or other concurrent severe disease
- •Participants suffering from major systemic illness necessitating long-term drug treatment including but not limited to hematologic conditions (e.g., hemolytic anemias, sickle cell anemia), acute myocardial infarction, unstable angina, uncontrolled hypertension, congestive heart failure (class III or class IV NYHA), or cerebrovascular accident, psychiatric or neurological disorder, autoimmune condition, received chronic (more than 14 days) therapy with systemic glucocorticoids (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations) within six months prior to enrollment
- •Participants who are smokers/alcoholics and/or known drug abusers
- •Participants with evidence or history of malignancy
- •Participant enrolled in any other clinical trial requiring drug therapy
- •Pregnant or lactating women or women of fertile age not using effective contraception
- •Any condition that could, in the opinion of the investigator, preclude the participants ability to complete the study or that may confound study outcomes.
结局指标
主要结局
1. Assessment of changes in HbA1c levels and Fasting and post-meal plasma glucose will be done
时间窗: 1.at screening and day 90 and baseline, day 30, day 60, and day 90. | 2.at the baseline and day 90.
2. Assessment of changes in insulin resistance (HOMA-IR) will be assessed
时间窗: 1.at screening and day 90 and baseline, day 30, day 60, and day 90. | 2.at the baseline and day 90.
次要结局
- 1. Assessment of change in lipid profile will be done(2. Assessment of changes in metabolic syndrome severity Z score (MetS Z score) will be assessed)
研究者
Dr Anuja Mukesh Phalak
Omkar Multispecialty Hospital