Effectiveness of Valli panchamoola choorna in Type 2 Diabetes Mellitus
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Changes in the following blood parameters:
研究概览
简要总结
Diabetes Mellitus is a major health endemic affecting mankind since ancient times. It is a well- known multifactorial metabolic disorder characterized by abnormally high blood glucose levels due to absolute or relative lack of insulin. The incidence of Diabetes has increased drastically in the recent times because of sedentary lifestyle and unhealthy dietary habits, which happens to be the main etiological factors for this disease. Type 2 Diabetes Mellitus makes up about 90% of global cases of Diabetes. Diabetes accounts for about 4.6 million deaths world wide every year and is projected by WHO to be the 7th leading cause of death by 2030. India currently represents 49% of the world’s diabetes burden.
Diabetes mellitus can be correlated to Prameha in Ayurveda classics.It is one among the Ashtamahagada. In Prameha, kaphapradhana tridosha dushti occurs. The dushyas involved are Medas, Mamsa, Rasa, Raktha, Majja, Sukra, Vasa, Lasika and Ojus.
The present study has been undertaken to evaluate the efficacy of ‘Vallipanchamoola choorna’ in managing Type II Diabetes Mellitus. Vallipanchamoola is mentioned in Susruta Samhitha Sutrasthana- “Dravya sangrahaneeya adhayayaâ€.Valli Panchamoola drugs are best for kaphanashana, srushtamutranilahara, vrushyam and indriya bodhanam.
The study is an interventional study with pre and post-test without control group.
A total of 26 participants of all genders aged 30 to 65 years registered in the OPD of Govt Ayurveda College Trivandrum satisfying the inclusion criteria will be selected for the study. The data will be collected through observations and lab investigations(FBS,PPBS and HbA1C).The medicine will be prepared as per the classical reference.
The selected participants will be given Vallipanchamoola choornam 6 grams twice daily,one hour before food, with lukewarm water for 90 days and review will be done after every 15 days. Assessment will be done on 0th , 30th ,60th and 91st days with subjective and objective parameters. The results will be analysed statistically,then summarized and conclusions will be made on the clinical effectiveness of the given drug.
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
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female participants of age group 30 to 65 years.
- •FBS(Fasting Blood Sugar)- 126 mg/dl to 200 mg/dl.
- •PPBS(Post Prandial Blood Sugar)- 200 mg/dl to 300 mg/dl HbA1C-6.5% to 9%.
排除标准
- •Those who are under insulin therapy and under other active and continuous medications for Type 2 Diabetes Mellitus.
- •Diagnosed case of drug induced Type 2 Diabetes Mellitus Women who are pregnant, lactating and planning to get pregnant.
- •ï»¿ï»¿Diagnosed cases of diabetes with established features of nephropathy and retinopathy.
- •ï»¿ï»¿Patients with severe cardiac, pulmonary, hepatic disorders and neoplasms.
结局指标
主要结局
Changes in the following blood parameters:
时间窗: OTH DAY | 30TH DAY | 60TH DAY | 91ST DAY
1)FBS
时间窗: OTH DAY | 30TH DAY | 60TH DAY | 91ST DAY
次要结局
- Changes in the following blood parameters:(1)PPBS)
- Changes in the following blood parameters:(1)HbA1c)
研究者
Dr Dineesha M
Govt Ayurveda Medical College And Hospital Trivandrum