A clinical study to evaluate the efficacy of Triphaladi Kwath in the management of prameha w.s.r. to diabetes mellitus type-2
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Reduction in sign and symptoms of Prameha
研究概览
简要总结
Nowadays, scholars of various disciplines are working on the problem, and various modern means and measures have been discovered, even than an effective drug without any side effects could not be stabilized. This highlights the need for clinical research in suitable designs to evaluate the efficacy of Ayurveda drugs in the treatment of Diabetes mellitus. No research work or documentation is available on the study of Triphaladi Kwath in the management of Prameha. Therefore, in this present study, it has been taken as a trial drug.
Triphaladi Kwath which is mentioned in Chakradatta chapter 35th Pramehachikitsa Prakaranam Shloka 21, has Katu, Tikta, Kashaya Rasa dominance, along with Madhur, Amla, & Laghu, Ruksha Guna help in alleviation of Kapha.
Considering all the aspects, the present study has been framed to compare the efficacy of Triphaladi Kwath. Subjects of either gender diagnosed with Prameha whose age group is between 20 to 60 years old will be selected. Triphaladi Kwath will be given to the subject orally in dosage of 48ml twice daily 1 hour before meals with Madhu as Anupana for 60 days.
The assessment will be done on the 0th day, 30th day, 60th day and 75th day (15 days after completion of intervention) by using subjective parameters and objective parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject of age group between 20 and 60 years and irrespective of caste, sex, religion, occupation, and socio-economic status.
- •Subject with classical signs and symptoms will be included.
- •Disease chronicity less than 5 years
- •Non Insulin Dependent Diabetes Mellitus
- •Subject willing to give informed consent to participate for 60 days.
排除标准
- •Patients below 20 and above 60 years of age
- •Patients suffering from other systemic disorders like renal or cardiac disorders
- •Sahaja and Jataja Madhumeha, i.e. DM Type 1 patients
- •Patient on insulin therapy
- •Pregnant and lactating womens
- •Patients with diabetic gangrene carbuncles and other complications of diabetes like diabetic nephropathy and diabetic retinopathy
- •Diabetic ketoacidosis.
结局指标
主要结局
Reduction in sign and symptoms of Prameha
时间窗: 75 days
次要结局
- Cost effective treatment and to observe if there are any adverse effect(75 days)
研究者
Dr Ankit Yadav
Kunwar Shekhar Vijender Ayurved Medical College & Research Center