A Randomized Controlled Comparative Clinical Trial to Evaluate the Efficacy of Herbomineral Formulation (GASY) in the Management of Diabetes Mellitus Type 2.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To Evaluate the Effect of Herbomineral Formulation GASY on Blood parameters FBS PP2BS & HbA1C
研究概览
简要总结
INTRODUCTION:-
Diabetesmellitus (DM) is one of the most common metabolic disorders worldwide. The global prevalenceof diabetes mellitus (DM) has shown an upward trend over the past few decades. Diabetesmellitus (DM) is divided into type 1 diabetes also termed as insulin dependentdiabetes mellitus [IDDM] and type 2 diabetes mellitus. The number of diabeticpeople is expected to rise to 366 million in 2030. The present study will beundertaken to evaluate the antihyperglycemic activity of formulation whichcontain extracts of Areca Catechu, Gymnema Sylvester, Shilajit and YasadBhasma.
NEED FOR STUDY: -
Diabetes Mellitus type2 (DM-2) is still not completely curable by the presentantidiabetic therapy. Insulin therapy is the satisfactory approach in Diabetes Mellitus type 2 (DM-2), even though ithas several drawbacks like insulin resistance, anorexia, brain atrophy, andfatty liver in chronic treatment. The present study is aimed to evaluate thesynergism effect of this combination in the management of the Diabetes Mellitus type 2 (DM-2).
AIM: -
To evaluate the effect of Herbo mineral formulation (GASY) inmanagement of Diabetes Mellitus type2 (DM-2).
OBJECTIVE: -
- To evaluate the effect of Herbomineral formulation (GASY) on Blood parameters (FBS, PP2BS & HbA1C).
- To evaluate the effect of Herbomineral formulation (GASY) in type 2 DM on the basis of symptoms seen in patients.
- To evaluate the adverse effects, if any.
MATERIALS ANDMETHODS: -
Plant Material: -
o Meshashringi (Gymnemasylvestre) hydroalcoholic leaf extract.
o Poog- Phala (Arecacatechu) ethanol fruit extract.
Mineral Material:-
o Shuddh shilajatu
o Yashada bhasma
· DrugIntervention: -
· *On-going treatment will be continuing.
| GROUP 1(Adjuvant Group) |
GROUP 2(Control Group)
|No. of Patients
20
20
|Mode of Administration
Oral
Oral
|Drug
GASY+ Antidiabetic Drugs
Antidiabetic Drugs
|Dose
5g per day (Sachet)
|Frequency and Time
Twice Daily before food
(Morning and Evening)
|Anupana
Warm water
Warm water
|Duration
90 days
90 days
|Follow up
6 follow-ups each on every 15 days (+/- 5 days)
6 follow-ups each on every 15 days (+/- 5 days)
| Study type |
OPEN LABELLED CONTROLLED COMPARATIVE CLINICAL STUDY.
|Study design
Randomized, Open, Comparative Clinical Study.
|Study centre
OPD and IPD of Kayachikitsa Department, Parul Ayurved Hospital, Khemdas Ayurveda Hospital, Parul Sevashram Hospital**,** Camps and Other Referrals.
|Sample size
40
|Duration of Treatment
90 days
INCLUSION CRITERIA: -
1)Patient of either gender between the agegroup of 20-70 years of age (both years inclusive).
-
Known cases of Diabetes Mellitus.
-
Patients with FBS 125mg/dl to 300 mg/dl and PP2BS140 mg/dl to 400 mg/dl (both inclusive)
-
Patients with HbA1C levels between 7.0 –12.0 %
EXCLUSION CRITERIA: -
-
Patients having FBS more than 300mg/dl, PP2BSmore than 400mg/dl, HbA1C more than 12 %
-
Patients showing acute complications and chroniccomplications - neuropathy, nephropathy, retinopathy.
-
Lactating and Pregnant Women
WITHDRAWAL CRITERIA: -
-
During trial if there is any episode of serious adverse event which requires urgent intervention.
-
Patients who want to withdraw from the clinical trial
-
Those patients who do not appear for regular follow-up.
-
During the course of trial, if patients FBS exceeds 300 mg/dl and PP2BS exceeds 400 mg/dl.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient of either gender between the age group of 20-70 years of age (both years inclusive).
- •Known cases of Diabetes Mellitus.
- •Patients with FBS 125mg/dl to 300 mg/dl and PP2BS 140 mg/dl to 400 mg/dl (both inclusive) 4) Patients with HbA1C levels between 7.0 – 12.0 %.
排除标准
- •Patients having FBS more than 300mg/dl, PP2BS more than 400mg/dl, HbA1C more than 12 % 2) Patients showing acute complications and chronic complications.
- •neuropathy, nephropathy, retinopathy. 3) Lactating and Pregnant Women.
结局指标
主要结局
To Evaluate the Effect of Herbomineral Formulation GASY on Blood parameters FBS PP2BS & HbA1C
时间窗: DAY 0 DAY 15 DAY 30 DAY 45 DAY 60 DAY 75 DAY 90
次要结局
- To Evaluate the Effect of Herbomineral Formulation GASY in Type 2 DM on the Basis of Symptoms Seen in Patients(DAY 0 DAY 15 DAY 30 DAY 45 DAY 60 DAY 75 DAY 90)
- To Evaluate the Adverse Effects if any(DAY 0 DAY 15 DAY 30 DAY 45 DAY 60 DAY 75 DAY 90)