Double Blind, Randomised, Placebo-Controlled Evaluation of Effect of Vidangadi Yoga in Prediabetes.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the effect of Vidangadi Yoga with lifestyle modification and placebo with lifestyle modification in Prediabetes on the basis of HbA1c, FBS, and PP2BS, lipid profile, urine routine and microscopic, fasting serum insulin, and HOMA-IR value.
研究概览
简要总结
· In Modern science, there isn’t a specific medicinal management for Prediabetes.Although lifestyle modification and dietary changes are capable of reversing this condition, it is seldom accepted and followed by patients. If we go through the literature, Prediabetes can also be associated with high blood pressure, low levels of high-density lipoproteins (HDL), and high levels of triglyceride. When these conditions are present along with obesity, they are associated with insulin resistance and can increase the risk of diabetes, heart disease, and stroke. Prediabetes can progress to type 2 diabetes which can further progress to high blood pressure, high cholesterol, heart disease, stroke, kidney disease, and nerve damage. Various studies have been done on type 2 diabetes but there are limited studies conducted on Prediabetes.In Ayurveda, Prameha Purvaroopa are thought to be correlated with Prediabetes, many other conditions can also be compared with Prediabetes. Medovridhhi, Sthaulya, Medo Roga, Bahudosha Avastha are also a condition that we can correlate with Prediabetes. Bahudosha Avastha is a condition where a cluster of symptoms gather in the body including the central and periphery also. Primarily there is a vitiation of Dosha in the body which further vitiates the Dhatus, Strotasa eventually in every disease. but in Prameha, not only Doshas but Dushyas like Rasa, Rakta, Mansa, Majja, Shukra, Oja, Ambu, Vasa, and Lasika also get vitiates. Except Rakta Dhatu all Dushyas are of KaphaCategory. Meda and Mansa are important Dushyas and are involved in all types of *Prameha.*this condition is the precursor of Medovaha Strotodushti.This study focuses assessment of Pre-diabetes through Vidangadi Yoga with lifestyle modification. Vidangadi Yoga is mentioned in the Charaka Samhita Sutrasthana Adhyaya 21 and it is said to be Atisthulyahara by Acharya Chakrapani. Hence, it can be a beneficial medicine in the management of Santarpanjanya conditions. Along with lifestyle modifications, it can be an effective management in prediabetes. This study proposes to assess the effect of Vidangadi Yoga along with lifestyle modifications in comparison with placebo with lifestyle modifications based on FBS, PP2BS, HbA1c Fasting serum insulin, HOMA IR, lipid profile, BMI and IDRS score along with subjective parameters. In the trial group Vidangadi Yoga will be given as per dose of 500 mg twice a day, while in the control group, placebo (roasted wheat flour) in the same dose and filled in similar capsule will be administered.
·
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients fullfilling the criteria of diagnosis according to AMERICAN DIABETES ASSOCIATION(HbA1c range between 5.7 to 6.4 percentage)
- •Patients willing to sign the informed the consent and can participate in the study procedure.
排除标准
- •Known case of diabetes mellitus, insulin dependent diabetes, juvenile diabetes, and gestational diabetes.
- •Known case of major systemic diseases like IHD, malignancy, and uncontrolled hypertension.
- •Patients on prolonged medications(greater than 6 weeks) with corticosteroids or any other drug that may influence the outcome of the study.
- •Pregnant and lactating women.
- •Patients with active infectious diseases like tuberculosis and hepatitis B.
- •Immunocompromised patients.
结局指标
主要结局
To compare the effect of Vidangadi Yoga with lifestyle modification and placebo with lifestyle modification in Prediabetes on the basis of HbA1c, FBS, and PP2BS, lipid profile, urine routine and microscopic, fasting serum insulin, and HOMA-IR value.
时间窗: At baseline, Day 90
次要结局
- To compare the effect of Vidangadi Yoga with lifestyle modification and placebo with(lifestyle modification in Prediabetes on the basis of weight, body composition mass)
- To evaluate incidence of Bahudoshavastha and status of Meda Dhatu on the basis of(symptoms of Sthaulya, Meda Vriddhi, Meda Pradoshaja Vikara and Meda Sarata in)
研究者
Dr Prarthana Patel
Parul Institute of Ayuved
