A Randomised Open Labelled Controlled Clinical Study to evaluate the efficacy of Dhanyamla Dhara in Diabetic Neuropathy
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessment of the patients condition will be done based on
研究概览
简要总结
Dhanyamla is a medicine which can be used as multifaceted treatment. It is Jeevana (sustainer of life), Daha Nashana (mitigate burning sensation), Vata Kapha Nashaka (pacify vata & kapha), Trishna hara (mitigate thirst), Deepana (enhance digestion), Jarana (digestive), Sramahara (relieves fatigue) and Klamahara (relieves exhaustion).
Since the symptoms of Diabetic Peripheral Neuropathy such as pain, burning sensation, numbness and tingling sensation can be correlated to the involvement of vitiated Vata and Kapha, Dhanyamla, having properties of Vata Kapha nashaka, Dahahara, Trisnahara, etc can be used for the treatment of Diabetic Peripheral Neuropathy. Hence*, Sarvanga dhara* by Dhanyamla in Diabetic Peripheral Neuropathy is choosen for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Metabolically stable diabetic subjects with symptomatic Diabetic Peripheral Neuropathy.
- •2.Subjects of all gender between the age group of 30-65 years.
- •3.Subjects fulfilling the diagnostic criteria.
- •4.Subjects whose HbA1C is between 6.5 to 10%.
排除标准
- •1.Subjects where HbA1C >10% and <6.5%.
- •2.Subjects suffering from Type-1 Diabetes or Gestational Diabetes.
- •3.Pregnant and lactating women.
- •4.Subjects suffering from infectious diseases and non-healing ulcer/ ulcers of foot.
- •5.Any systemic illness that can interfere with the course of treatment.
结局指标
主要结局
Assessment of the patients condition will be done based on
时间窗: Before intervention 0th day | After intervention 7th day | Follow up 14th day
1.Changes in Michigan Neuropathy Screening Instrument (MNSI) Questionnaire score
时间窗: Before intervention 0th day | After intervention 7th day | Follow up 14th day
2.Changes in Toronto Neuropathy Clinical Scale (TCNS) Score
时间窗: Before intervention 0th day | After intervention 7th day | Follow up 14th day
3.Changes in Visual Analog Scale (VAS)
时间窗: Before intervention 0th day | After intervention 7th day | Follow up 14th day
次要结局
- 1. Changes in FBS value(2. Changes in PPBS value)