| CTRI Number |
CTRI/2025/03/082466 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess the impact of 24 hour fermented millet Ambali powder with or without herbal kwatha in managing Type-2 Diabetes in elderly individuals |
|
Scientific Title of Study
|
An exploratory comparative clinical study to assess the impact of 24-hour fermented millet Ambali powder with or without herbal kwatha in managing Type-2 Diabetes in elderly individuals |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Pradeep Kumar Prajapati |
| Designation |
Vice Chancellor, Dr. S.R. Rajasthan Ayurved University Jodhpur |
| Affiliation |
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
VC office, Adminstrative block, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9818575845 |
| Fax |
|
| Email |
prajapati.pradeep1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Harish Kumar Singhal |
| Designation |
Professor and HOD |
| Affiliation |
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
Room No. 155 PG Department of Ay. Pediatrics, PGIA Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636622206 |
| Fax |
|
| Email |
ayurharish14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Harish Kumar Singhal |
| Designation |
Professor and HOD |
| Affiliation |
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
Room No. 155 PG Department of Ay. Pediatrics, PGIA Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9636622206 |
| Fax |
|
| Email |
ayurharish14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Organo Nutri p.no. 01, Jeera mandi, krishi mandi, mandore road, jodhpur rajasthan india, 342007 |
|
|
Primary Sponsor
|
| Name |
Organo Nutri |
| Address |
Organo Nutri p.no. 01, Jeera mandi, krishi mandi, mandore road, jodhpur rajasthan india, 342007 |
| Type of Sponsor |
Other [Nutraceutical company] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
Nagour Road, Karwar Jodhpur, Rajasthan 342037 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Harish Kumar Singhal |
Sanjeevani Ayurveda Hospital |
Room No. 04, Saanjeevani ayurveda hospita, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur 342037
Jodhpur
RAJASTHAN |
9636622206
ayurharish14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Dr. Sarvepalli radhakrishnan Rajasthan Ayurved University, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E11||Type 2 diabetes mellitus. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Heat killed probiotic 8 millte powder with diet having 8 milltes, Apathya: | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Heat killed probiotic 8 millet ambali powder with diet having sprouted wheat and herbal kwath of leaves of moringa pudina coriander giloy jamun and methi , Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diabetes subjects of both sex of age group of 60-70 years.
Fasting blood glucose level 121-250 mg/dL |
|
| ExclusionCriteria |
| Details |
Subjects with food allergy, chronic diseases or on life saving medication pregnant/ lactating women.
smokers consuming more than 2 alcohol serving per week |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 24Hr. Fermented Millet Ambali Powder with or without Herbal Kwatha is effective in managing Type-2 Diabetes in elderly individuals. |
24Hr. Fermented Millet Ambali Powder with or without Herbal Kwatha is effective in managing Type-2 Diabetes in elderly individuals. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 24Hr. Fermented Millet Ambali Powder with or without Herbal Kwatha is effective in the reduction of blood sugar fasting level, Uric acid, HbA1C, increase in Vitamin B12 and changes in LFT, KFT and lipid profile parameters Safety Recording |
03 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
25/03/2025 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
A multiple centre, prospective randomized open label trial with sample size of 80 divided in two group as 40 in each. Group A will be given heat killed probiotic 8 millet Ambali Powder with diet having 8 positive millets in individuals with diabetes for three month of duration and group B will be giiven Heat killed probiotic 8 millet Ambali powder with diet having sprouted wheat and herbal Kwath (Kadha) of leaves of Moringa, Pudina, Coriander, Giloy, Jamun & Methi in individuals with diabetes for three-month duration. Primary Objectives – To evaluate the efficacy of 24Hr. Fermented Millet Ambali Powder with or without Herbal Kwatha in managing Type-2 Diabetes in elderly individuals Secondary Objectives- To evaluate the efficacy of 24Hr. Fermented Millet Ambali Powder with or without Herbal Kwatha in reduction of blood sugar fasting level, Uric acid, HbA1C, increase in Vitamin B12 and changes in LFT, KFT and lipid profile parameters. |