“A Randomized Clinical Comparative Study on Chitraktriphaladi Kashayam with Madhu and Chitraktriphaladi Kashayam Ghana Vati in the Management Of Madhumeha Type-2 Diabetes Mellitus.â€
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in Cardinal Symptoms of Type -II Diabetes Mellitus ( Madhumeha )
研究概览
简要总结
AIMS& OBJECTIVES:
*1.*To assess clinical efficacy of Chitraktriphladi Kashayam with Madhu inthe management of a series of patients suffering from Madhumeha (DM Type II).
2. To assess clinical efficacy of Chitraktriphladi Kashayam Ghana Vati inthe management of a series of patients suffering from Madhumeha (DM Type II).
To compare theefficacy of Chitraktriphaladi Kashayamwith Madhu and Chitraktriphaladi Kashayam Ghana Vati in the management of Madhumeha (DM Type II).
HYPOTHESIS
Nullhypothesis [H0]:
Chitraktriphaladi Kashayamwith Madhu and ChitraktriphaladiKashayam Ghana Vati are equally effective in the Management Of Madhumeha (Type-2 Diabetes Mellitus).â€
MATERIALS &METHODS
Following materials and methods will be employedfor conducting the present research work-
CLINICAL STUDY
Following materials andmethods will be employed for conducting the present research work-
Selection of Cases:
§ Thestudy will be conducted in 30 clinically diagnosed and confirmed patients of Madhumeha (Type II Diabetes Mellitus)from OPD/IPD of NIA hospital, Jaipur. These patients will be randomly dividedinto two groups - Group A, Group B with 15
patients in each group.
DiagnosticCriteria
§ Diagnosis basedon presenting clinical features of Madhumeha(Type II DM).
§ Subjects with FBS> 126 mg/dl, PPBS > 140-300 mg/ dl
StudyDesign:
The present study issupposed to be-
· Level of study : OPD/IPD
· Study type : Interventional,Single Centre
· Purpose : Treatment
· Masking : Open Label
· Timing : Prospective
· End point : Safety and efficacy
· No. of groups : Two (15patients in each group)
No. ofpatients 30
· Duration of Study : 30 days
· Follow-up : 15thday, 30th day after initial assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients giving the clinical history of DM (Type II).
- •2.Patients having hyperglycaemia confirmed by laboratory investigations i.e. Fasting Blood Sugar (FBS) ≥ 126mg/dl or Post Prandial Blood Sugar (PPBS) ≥ 140-300 mg/dl 3.Presence of Cardinal symptoms of Diabetes Mellitus eg.
- •(3P- polyuria, polydypsia, polyphagia).
排除标准
- •i.Patients below 30 years of age & above 70 years of age.
- •ii.Patients having Type I DM.
- •iii.Patients of Type II DM who are on insulin therapy.
- •iv.Patients having any serious illness like Coronary Artery Disease, malignancy, hypertension > 140/90 mm of Hg etc.
- •v.Drug induced DM.
- •vi.F.B.S. > 200 mg/dl and P.P.B.S. > 300 mg/dl.
- •vii.Patients having chronicity of more than 5 years.
- •viii.DM with complications.
- •ix.Pregnant and lactating mother.
结局指标
主要结局
Changes in Cardinal Symptoms of Type -II Diabetes Mellitus ( Madhumeha )
时间窗: 30 Days
次要结局
- Changes in the objective parameters.(30 Days)