Efficacy of Kaishore Guggulu and Asanadi Kwatha in the management of newly diagnosed cases of Madhumeha w.s.r Type 2 diabetes mellitus : an open-label randomized comparative parallel group study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in fasting blood sugar and post prandial blood sugar from baseline .
研究概览
简要总结
Diabetes Mellitus (DM) is a group of metabolic disorders characterized by hyperglycemia due to reduced insulin secretion, decreased glucose utilization, and increased glucose production. Its symptoms include frequent urination, increased thirst, and hunger. Rising global incidence is linked to reduced physical activity and obesity, with prevalence increasing from 4.7% in 1980 to 8.5% in 2014. According to the International Diabetes Federation, by 2045, 783 million people will have diabetes, with the majority in low- and middle-income countries. Alarmingly, younger age groups and adolescents are increasingly affected. India has the highest number of diabetics globally, earning the title of "diabetic capital of the world."
The aim of this study is to generate preliminary evidence regarding the efficacy and safety of Kaishore Guggulu and Asanadi Kwatha in the management of newly diagnosed mild to moderate cases of Madhumeha (Type 2 diabetes mellitus).
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研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of any gender aged 35 to 65 years diagnosed with Type 2 DM.
- •Fasting Blood sugar 126-179 mg/dl.
- •Glycosylated Hemoglobin (HbA1c) 6.5- 7.9% Subjects willing to provide written informed consent and able to come for follow up on scheduled visits.
排除标准
- •Individuals diagnosed with type 1 DM.
- •Subjects not taking any oral hypoglycemic drugs or insulin therapy.
- •Individuals with type 2 DM with poor control (HbA1C greater than or equal to 8 %).
- •Subjects suffering from the acute and chronic complications of Diabetes mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy, diabetes ketoacidosis, hyperglycemic coma, peripheral artery disease, etc.
- •which require emergency management.
- •Subjects with history of any cardiovascular disease such as coronary artery disease, congestive heart failure, Hypertension, valvular heart disease , etc.
- •Subjects with comorbidities such as Bronchial Asthma, COPD, Cerebrovascular Accident, tuberculosis, etc.
- •Subjects having immunocompromised state such as HIV or taking any immunosuppressive medications.
- •Subjects with history or active malignancy.
- •Subjects suffering from any major systemic illness necessitating long term treatment like Rheumatoid arthritis, psychiatric disorders, and endocrinal disorders.
- •Subjects on corticosteroids, beta agonist, estrogen, progestins, antidepressants, antipsychotics etc that may affect glucose metabolism.
- •Subject suffering from any hepatic disorder (SGPT and SGOT more than two times the upper limit of normal) Subjects suffering from chronic kidney disease or any renal disorder (serum creatinine greater than 1.2 mg/dL).
- •Pregnant and lactating women.
- •Subjects taking medicines from any other traditional medicine systems for type 2 DM.
- •Subjects with a history of smoking, alcohol intake or any substance abuse.
- •Subjects having hypersensitivity to any of the trial interventions or their ingredients.
- •Subjects who have completed participation in any other clinical trial during the past six months.
结局指标
主要结局
Change in fasting blood sugar and post prandial blood sugar from baseline .
时间窗: Day 1, 91
次要结局
- Change in HbA1C from baseline.
- Change in health related quality of life assesed through SF12 questionnaire(Day 1, 91)
- Change in grading of symptoms of Madhumeha assessed through “Developing(guidelines for clinical research methodology in Ayurveda”)
- Incidence of adverse events if any.(Day 1, 91)
- Change in the laboratory safety parameters (LFT ,KFT, CBC , Lipid profile) from(baseline.)
研究者
Dr Ayush Gupta
Ayurvedic and Unani Tibbia College and Hospital