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临床试验/CTRI/2024/03/064450
CTRI/2024/03/064450招募中3 期

Antihyperglycemic and Hypolipidemic effect of Kodo millet (paspalum scrobiculatum L.) diet with Yogabhyas in Sthool Madhumehi (Type II Diabetes Mellitus) - A Randomized Control Trial

Dr Sneha Prakash Borkar1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
84
试验地点
1
主要终点
a. To study the effect of Kodo millet Diet with Yogabhyas on blood sugar level in Sthool Madhumehi Type II Diabetes Mellitus

研究概览

简要总结

The aim of the study is to study the Antihyperglycemic and Hypolipidemic effect of Kodo Millet diet in sthool madhumehi Type II Diabetes Mellitus. There will be two groups. 42 patients will be recruited in each group. Group A that is intervention group will be provided 50 gram of Kodo millet Upma daily before meal for one month. The Yoga practices, pathy apathya and regular oral  anti diabetic medicine will be kept common in both the groups. Total duration of treatment will be 45 days. The effect of Kodo MIllet diet will be assessed on day 15, day 30 and day 45 with the help of various subjective and objective parameters. Statistical analysis will be done and conclusion will be drawn.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
40.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1 Patients of either sex in the age group of 40 to 65 years 2 Sign and symptoms of Diabetes Mellitus 3 Fasting blood sugar level more than or equal to 126 mg per dl up to 200 mg per dl 4 Postprandial blood sugar PPBS more than 200 mg per dl up to 300 mg per dl 5 Glycated Haemoglobin HbA1c more than or equal to 6.5 percent to less than 8 percent 6 Lipid profile a Total Cholesterol 200 to 300 mg per DL b LDL Cholesterol level 130 to 190 mg per DL c HDL Cholesterol level 40to 60 mg per DL d Serum Triglycerides 150 to 500 mg per DL e BMI 25 to 40 kg per meter square.

排除标准

  • 1 Patients with juvenile Diabetes Mellitus.
  • 2 Patients having insulin dependent Diabetes Mellitus IDDM and receiving insulin type 1 3 Patients having complications with cardiac problems 4 Diabetes due to Endocrinopathies eg Phaeochromocytoma, Acromegaly, Cushing’s syndrome, hyperthyroidism etc 5 Pregnant and lactating mother 6 Patient suffering from any severe systemic disease.

结局指标

主要结局

a. To study the effect of Kodo millet Diet with Yogabhyas on blood sugar level in Sthool Madhumehi Type II Diabetes Mellitus

时间窗: 15 day 30 day 45 day

b. To study the effect of Kodo millet Diet with Yogabhas on Triglycerides, HDL LDL, VLDL in Sthool Madhumehi Type II Diabetes Mellitus

时间窗: 15 day 30 day 45 day

c. To study the effect of Kodo millet diet with Yogabhas in the management of sign and symptoms of Sthool Madhumehi Type II Diabetes Mellitus

时间窗: 15 day 30 day 45 day

次要结局

  • a. To study the effect of Kodo Millet diet with Yogabhyas on weigh, BMI, abdominal circumference and waist circumference in Sthool Madhumehi Type II Diabetes Mellitus(b. To review the literature of Aahar, Trunadhanya or Kudhanya or Shukadhanya Kodo or Kodrava Prameha or Madhumeha, Sthoulya according to Ayurveda.)

研究者

发起方
Dr Sneha Prakash Borkar
申办方类型
Other []
责任方
Principal Investigator
主要研究者

Dr Sneha P Borkar

Jupiter Ayurved Medical College Shankarpur Nagpur

研究点 (1)

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