Assessing the effectiveness of vamana karma using madanphala majja in the management of prameha purvarupa avastha (prediabetes) randomized controlled clinical trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Reduce HbA1c in percentage.
研究概览
简要总结
The increasing burden of lifestyle disorders, particularly prediabetes and diabetes, is a significant global public health concern. Prediabetes is a precursor to type 2 diabetes and is characterized by elevated blood sugar levels that are not yet high enough for a diabetes diagnosis. It affects millions and carries a high risk of progression if not managed early. In Ayurveda, prameha and its early manifestations (purvarupa avastha) are considered treatable stages.
This randomized controlled clinical trial will evaluate the effectiveness of vamana karma using Madanphala Majja in the management of prameha purvarupa avastha, which corresponds to the prediabetic stage in modern medicine. According to Ayurvedic principles, bahudrava kapha and abaddha meda are the primary pathological factors in prameha. Therefore, Samprapti vighatana should focus on these two components. Shodhana karma eliminates the vitiated dosha through its nearest route; for kapha, this is via urdhvabhaga (oral route), making vamana karma the preferred approach.
Prameha is a metabolic disorder with kapha dominance, and the seat of Kapha is the urdhva amashaya. Thus, vamana karma offers a logical route for kapha expulsion. madanphala is considered a safe and effective vamaka dravya. In this study, eligible participants will be randomly divided into two groups: Group A will undergo vamana with Madanphala Majja yoga, and Group B will receive Vamana with Ikshvaku Madhuyashti kashaya yoga.
Both groups will follow a standardized Panchakarma protocol including Deepana-Pachana, Snehapana, Abhyanga, Swedana, Vamana Karma, and Samsarjana Krama. The primary outcomes will include improvement in subjective symptoms and reduction in HbA1c levels. This study aims to assess whether timely Ayurvedic purification therapy can prevent or delay the progression from prediabetes to type 2 diabetes, thereby contributing to integrative public health strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient of prameha purvarupa avastha.
- •Patient having an HbA1c level between 5.7 percent to 6.4 percent.
- •Patient of either sex and irrespective of their occupation, or socioeconomic status.
排除标准
- •Patient having HbA1c levels less than 5.7 percent and greater than 6.4 percent.
- •Age less than 30 years and greater than 60 years.
- •Patient of Type-1 DM or the patient of type-2 DM taking insulin.
结局指标
主要结局
Reduce HbA1c in percentage.
时间窗: For subjective criteria -0th day (baseline), after snehapana,after samsarjana krama,after 15th day of samsarjana krama. | For objective criteria - baseline,after 15th day of samsarjana krama.
Improvement in signs and symptoms of prameha purvarupa avastha.
时间窗: For subjective criteria -0th day (baseline), after snehapana,after samsarjana krama,after 15th day of samsarjana krama. | For objective criteria - baseline,after 15th day of samsarjana krama.
次要结局
- Improvement in overall energy levels. Changes in work productivity.(0th day (baseline), after snehapana,after samsarjana krama,after 15th day of samsarjana krama)
研究者
Dr Apurva Anil Gade
C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad 431011
