| CTRI Number |
CTRI/2024/03/064450 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To reduce sugar and cholesterol in Diabetes with the help of Kodo millet diet and Yoga |
|
Scientific Title of Study
|
Antihyperglycemic and Hypolipidemic effect of Kodo millet (paspalum scrobiculatum L.) diet with Yogabhyas in Sthool Madhumehi (Type II Diabetes Mellitus) - A Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sneha P Borkar |
| Designation |
Associate professor |
| Affiliation |
Jupiter Ayurved Medical College Shankarpur Nagpur |
| Address |
2nd floor, Department of Swasthavritta and Yoga, Jupiter Ayurved Medical College, Shankarpur Nagpur
Nagpur
MAHARASHTRA
440014
India |
| Phone |
9975405822 |
| Fax |
|
| Email |
sborkar49@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidya Wasnik |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurved College Nagpur |
| Address |
Ground floor, Department of Swasthavritta and Yoga, Govt Ayurved Medical College Raje Raghuji Nagar Sakkardara Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
8830743966 |
| Fax |
|
| Email |
vidya.wasnik@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vidya Wasnik |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurved College Nagpur |
| Address |
Ground floor, Department of Swasthavritta and Yoga, Govt Ayurved Medical College Raje Raghuji Nagar Sakkardara Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
8830743966 |
| Fax |
|
| Email |
vidya.wasnik@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved Medical College Nagpur |
|
|
Primary Sponsor
|
| Name |
Dr Sneha Prakash Borkar |
| Address |
Jupiter Ayurved Medical College Shankarpur Nagpur |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sneha Prakash Borkar |
Government Ayurved College Nagpur |
OPD No. 6, Swasthyarakshan OPD Ground floor, Raje Raghuji Nagar Sakkaradara Nagpur
Nagpur
MAHARASHTRA |
9975405822
sborkar49@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Ayurved College Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kodo Millet, Reference: Charak Samhita, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 50(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -In this Group Kodo Millet diet with Yogabhyas chart will be provided along with his regular oral medicine.
Each patient of group A will be advised to cook 50 grams (raw) Kodo millet grains daily and consume it in the form of Upma for one month.
Regular online Yogabhyas will be done with both the groups at 6.00 to 7.00 am daily. Common regular dietetic restriction will be advised to both the group
Upma recipe: | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:In this group only Yogabhyas along with his regular oral medicine will be advised.
Regular online Yogabhyas will be done with both the groups at 6.00 to 7.00 am daily. Common regular dietetic restriction will be advised to both the group
, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
a. To study the effect of Kodo millet Diet with Yogabhyas on blood sugar level in Sthool Madhumehi Type II Diabetes Mellitus
b. To study the effect of Kodo millet Diet with Yogabhas on Triglycerides, HDL LDL, VLDL in Sthool Madhumehi Type II Diabetes Mellitus
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
|
15 day 30 day 45 day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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.
c. To review the literature of Diabetes Mellitus, Obesity, Millets and Kodo Millet paspalum scrobiculatum according to Modern science.
|
30 day 45 day |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |