Randomized Comparative Clinical Study to Evaluate Efficacy Of Udak Mehadi Ghan Vati With Eladi Ghan Vati in Prameh Purvarupa With Special Reference to Pre Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Angasada
研究概览
简要总结
Study Purpose
The purpose of this study is to evaluate and compare the efficacy of Udak Mehadi Ghan Vati and Eladi Ghan Vatiin managing Prameh Purva Rupa .The goal is to examine whether early intervention with Ayurvedic medicines can reduce or prevent the progression to diabetes mellitus
Condition Disease
Ayurvedic Diagnosis Prameh Purva Rupa prodromal stage of Prameha
Modern Correlation Prediabetes based on Fasting Blood Sugar 100 to 125 mg per dL Postprandial Blood Sugar 140 to 199 mg per dL and HbA1c 5.7 to 6.4 per dl
Interventions
Group A Trial Group Udak Mehadi Ghan Vati Dose 250 mg orally twice daily Anupana Lukewarm water Study Duration 90 days
Group B Control Group Eladi Ghan Vati Dose 250 mg orally twice daily Anupana Lukewarm water Study Duration 90 days
Study Design
Type Randomized openlabel double arm comparative clinical trial
Duration 24 months including recruitment treatment and analysis
Randomization Block randomization
Sample Size 146 participants 73 in each group
Assessment Parameters Subjective symptoms of Prameh Purva Rupa and objective markers including Fasting Blood Sugar FBS Postprandial Blood Sugar PPBS and HbA1c
Population
Adults aged 30 to 65 years
Diagnosed with prediabetes as per ADA WHO criteria
Exhibiting 5 classical symptoms of Prameh Purva Rupa eg numbness or burning in hands and feet excessive thirst sweet taste in mouth heaviness etc
Recruited from the OPD and IPD of Ayurved Hospital attached to an Aarihant Ayurvedic Medical College and Research Institute
Expected Outcome
The study aims to determine whether Udak Mehadi Ghan Vati provides superior clinical benefits over Eladi Ghan Vati in managing prediabetic conditions Expected outcomes include reduction in subjective symptoms of Prameh Purva Rupa and improvement in FBS PPBS and HbA1c values potentially preventing progression to full blown diabetes mellitus
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant 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
- •Age 30 to 65yrs of both sexes Subject who are willing to give written informed consent Plasma glucose level Fasting 100 to 125 mg per dl Postprandial 140 to 199 mg per dl HB1AC greater than 6.4 per hundred ml Not known case of Diabetes Mallitus Presence of prameha purvaroopa as described in diagnostic criteria.
排除标准
- •Patient diagnosed with diabetes or having diabetes complications.
- •Patient suffering from bleeding disorder sleep disorders gum diseases H.pylori infections chronic inflammation anemia.10 Patient suffering from pancreatitis lumbar spondylitis AIDS HEPATITIS and TB.
结局指标
主要结局
Angasada
时间窗: 0 , 30, 60 and 90 days
Angagandha
时间窗: 0 , 30, 60 and 90 days
Shwasa
时间窗: 0 , 30, 60 and 90 days
FBS
时间窗: 0 , 30, 60 and 90 days
PPBS
时间窗: 0 , 30, 60 and 90 days
HbA1c
时间窗: 0 , 30, 60 and 90 days
Kara-pada suptata
时间窗: 0 , 30, 60 and 90 days
Kara-pada daha
时间窗: 0 , 30, 60 and 90 days
Madhurasyata
时间窗: 0 , 30, 60 and 90 days
Pipasa
时间窗: 0 , 30, 60 and 90 days
Sweda
时间窗: 0 , 30, 60 and 90 days
Alasya
时间窗: 0 , 30, 60 and 90 days
Nidra
时间窗: 0 , 30, 60 and 90 days
次要结局
- FBS, PPBS , HB1AC(after 30 days after 60 days after 90 days)
研究者
TUSHAR SURESH PUNSE
Aarihant Ayurvedic Medical College and Research Institute