| CTRI Number |
CTRI/2026/01/100853 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of a Barley Diet on Prediabetes |
|
Scientific Title of Study
|
To evaluate the effect of Yaavak (Yava- Odana Kalpana) a dietary
intervention in prediabetes: A single arm study |
| 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 Jayanti Dhakad |
| Designation |
PG Scholar Department of Swasthavritta and Yoga |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh, New Delhi |
| Address |
Room no. 222 PG Department of Swasthavritta , Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh New Delhi
South West
DELHI
110073
India |
| Phone |
7909953239 |
| Fax |
|
| Email |
jayantidhakad19041999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jai Singh Yadav |
| Designation |
Associate Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh, New Delhi |
| Address |
Room no. 222 PG Department of Swasthavritta , Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh New Delhi
South West
DELHI
110073
India |
| Phone |
7568730726 |
| Fax |
|
| Email |
dr_jaisinghyadav@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jai Singh Yadav |
| Designation |
Associate Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh, New Delhi |
| Address |
Room no. 222 PG Department of Swasthavritta , Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh New Delhi
South West
DELHI
110073
India |
| Phone |
7568730726 |
| Fax |
|
| Email |
dr_jaisinghyadav@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brahm Prakash Ayurved Charak Sansthan |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of Swasthavritta , Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh New Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 Jayanti Dhakad |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
OPD NO. 20,and Room no. 222 PG Department of Swasthavritta and Yoga , Khera Dabar,Najafgarh New Delhi
South West
DELHI |
07909953239
jayantidhakad19041999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CBPACS |
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: PRAMEHA-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: N/A, Ritucarya: N/A, Acara Rasayana:N/A, Other:N/A, Pathya/Apathya:yes, Pathya:Yaavak (Yava-odana kalpana)
•Time of administration - As a first meal of the day / Breakfast.
•Dose- 1 pala (48 gm approx. 50gm) and prepared Odana of it as prescribed
Duration- 3 months (90 days)
, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with age between 30-60yrs.
2. Sex: Both male and female
3. FBS-100-125mg/dl
4. PP -140-199mg/dl
5. HbA1c-5.7 -6.4%.
|
|
| ExclusionCriteria |
| Details |
1. Known case of Diabetes Mellitus Type- 1
2. Known case of Diabetes Mellitus Type-2
3. Cases identified with diabetes during the process of screening will be referred to the Kaya Chikitsa OPD of CBPACS.
4. Patients with diabetic complications.
5. Gestational diabetes.
6. Pregnant ladies and lactating mothers.
7. Patients having other serious illness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Glycated Haemoglobin (HbA1c) Levels:
2) Postprandial Glucose Levels:
3) FBS
|
0th day 30th day 60th day 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Patient-Reported Outcomes:
2) Assessment of subjective criteria, and treatment satisfaction through patient-reported outcome measures related to pre-diabetes.
|
0th day 30th day 60th day 90th day |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/03/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study aims to evaluate the effect of Yaavak (Yava-Odana Kalpana) as a dietary intervention in individuals with prediabetes. Prediabetes is considered a crucial reversible stage correlated with Prameha purvarupa in Ayurveda A single-arm clinical study will be conducted on 38 prediabetic patients for 90 days at CBPACS New Delhi Yaavak prepared from Nistuska Yava will be administered daily as breakfast The efficacy will be assessed using objective parameters (HbA1c FBS PPBS) and subjective symptoms of poorvaroopa of Prameha Statistical analysis will determine the significance of glycaemic improvement The study seeks to generate evidence for an affordable culturally acceptable Ayurvedic dietary approach in prediabetes management |