Clinical Study on Vijaysaradi Ghanvati and Madhumehari Vati in the Management of Madhumeha (Type 2 Diabetes ) - An Open Randomized Comparative Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- efficacy
研究概览
简要总结
Total 60 patients of Madhumeha were registered for study, selected patients were divided in two groups on the basis of computer generated randomization.
Group A - Vijaysardi Ghanvati was given 2 Vati (500 mg each) TDS for a duration of 8 weeks with plain water before meal.
Group B - Madhumehari Vati was given 1 tablet (1000mg) TDS for a duration of 8 weeks with plain water before meal.
Effect of therapy:
Prabhutmutrata was reduced by 80%in both groups, which was statistically significant significant.
Pindikodwestan was reduced by 92% and 81.93% in Group A and B respectively Both the groups had provided statistically significant improvement on Pindikodwestan.
KaraPada Daha was reduced by 89% and 92.30% in Group A and B respectively. Both the groups had provided statistically significant improvement on KaraPada Daha.
Kshudadhikya was reduced by 64.3% and 39.75%in Group A and B respectively. Both the groups had provided statistically significant improvement on Kshudadhikya.
KaraPada Supti was reduced by 90% and 90.44%in Group A and B respectively. Both the groups had provided statistically significant improvement on KaraPada Supti.
Ati-pipasa was reduced by 64% and 69.38%in Group A and B respectively. Both the groups had provided statistically significant improvement on Ati-pipasa.
Sweda Adhikya was reduced by 60% and 39.75%in Group A and B respectively. Both the groups had provided statistically significant improvement on Sweda Adhikya.
Guru Gatratawas reduced by 90% and 100%in Group A and B respectively. Both the groups had provided statistically significant improvement on Guru Gatrata.
Nindradhikya was reduced by 47.5% and 58.90%in Group A and B respectively.. Both the groups had provided statistically significant improvement on Nindradhikya*.*
Group-A and Group-B showed 11.52% and 12.16 reductions in FBS respectively, which was significant in both groups.
Group-A and Group-B showed 12.66% and 18.55% reduction in PPBS respectively. Reduction in PPBS in Group-A was significant but it was highly significant in Group-B.
Group-A and Group-B showed 2.56% and 11.47% reduction in HbA1C respectively. Reduction in HbA1C in Group-A was insignificant but it was significant in Group-B.
Group-A and Group-B showed 10.44% and 54.86% decrease in fasting Urine sugar respectively, which was insignificant in Group**-A but significant in Group-**B.
Overall effect of therapy:
In Group A, complete remission was observed in 3 (11%) patient, markedly improvement was observed in 5 (19%) patients, moderate improvement was observed in 16 (59%) patients, mild improvement was observed in 3 (11%) patients. In Group B, complete remission was observed in 4 (13.5%) patient, markedly improvement was observed in 8 (28%) patients, moderate improvement was observed in 13 (45%) patients, mild improvement was observed in 4 (13.5%) patients.
Ø On analyzing the data overall Group**-B (Madhumehari Vati) showed better results than Group-**A (Vijaysaradi Ghanvati Group).
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
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having signs and symptoms of Madhumeha (Type 2 Diabetes)
- •Fasting plasma glucose ≥ 126 mg/dl or Post Prandial glucose level ≥ 200 mg/dl.
排除标准
- •Age less than 20 years more than 70 years.
- •Patients of Diabetes mellitus receiving Insulin.
- •Patients having chronic complications of Diabetes mellitus like Retinopathy, Neuropathy Nephropathy, Coronary artery disease, Peripheral vascular disease, Cerebro-vascular disease and other chronic debilitating disease like STD etc.
- •pregnant and lactating women.
结局指标
主要结局
efficacy
时间窗: 2 month
次要结局
- safety(2 month)