| CTRI Number |
CTRI/2025/08/093810 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
How Barley and Brown Rice Water Affect Blood Sugar in Diabetes |
|
Scientific Title of Study
|
Oral glucose tolerance of individuals with type 2 diabetes mellitus to barley water and brown rice water: a randomized 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 |
REDDY RAMCHARAN TEJA |
| Designation |
Post Graduate |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
Department of Dietetics and Nutrition SDM College of Naturopathy and Yogic Sciences Ujire Belthangady
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8328565677 |
| Fax |
|
| Email |
charansharwa33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
REDDY RAMCHARAN TEJA |
| Designation |
Post Graduate |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
Department of Dietetics and Nutrition SDM College of Naturopathy and Yogic Sciences Ujire Belthangady
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8328565677 |
| Fax |
|
| Email |
charansharwa33@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashanth Shetty |
| Designation |
Professor and Dean |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences, Ujire |
| Address |
Department of Nutrition and Dietetics, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic sciences ujire belthangady
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9448252696 |
| Fax |
|
| Email |
drprashanth9@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Yoga and Nature cure hospital, Shanthivana, Dharmasthala, Belthangady taluk, Karnataka, India 574216 |
|
|
Primary Sponsor
|
| Name |
REDDY RAMCHARAN TEJA |
| Address |
Department of Nutrition and Dietetics, SDM College of Naturopathy and Yogic Sciences Ujire Belthangady Dakshina Kannada karnataka, India 574240 |
| Type of Sponsor |
Other [SELF] |
|
|
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 REDDY RAMCHARAN TEJA |
SDM Yoga and Nature cure hospital |
Department of Nutrition and Dietetics, Shantivana Dharmasthala, Karnataka
Dakshina Kannada
KARNATAKA |
8328565677
charansharwa33@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM Institutional Ethical Committee |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Barley Water |
300 ml of Barley water mixed with 75 grams of glucose
Duration required to drink: 2 minutes |
| Comparator Agent |
Brown Rice water |
300 ml of brown rice porridge mixed with 75 grams of glucose
Duration required to drink: 2 minutes |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with type 2 Diabetes Mellitus meeting the American Diabetic Assosciation diagnostic criteria and those who are on oral anti diabetic therapy |
|
| ExclusionCriteria |
| Details |
1) T2DM patients with hypertension
2) History of Kidney or Liver failure
3) Subjects who are underweight or with morbid obesity
4) T2DM patients who are on insulin therapy
5) corticosteroids and any other acute illness
6) History of alcohol or drug abuse |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Random Blood Glucose |
Baseline, after 30 min, 60 min, 90 min and 120 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
09/09/2025 |
| 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="1"
Months="6"
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
|
Diabetes mellitus is a chronic illness marked by hyperglycaemia, or elevated blood glucose, and its common symptoms include thirst, polyuria, polydipsia, and weight loss. Diabetes is a class of metabolic disorders defined by elevated blood sugar levels brought on by deficiencies in either insulin production, insulin action, or both. Diabetes’ chronic hyperglycaemia is linked to long-term harm, malfunction, and organ failure, particularly to the kidneys, eyes, heart, nerves, and blood vessels.
Barley (Hordeum vulgare L.) belongs to the Poaceae family. It is the fourth important cereal crop cultivated around the world after wheat, rice; maize in terms of quantity produced and planted areas. Barley’s nutritious and bioactive components make it a widely sought-after food for health purposes. beta-glucan, a member of the hemicellulose plant polysaccharides (soluble fiber) family, is a polymer of beta-d-glucose formed by glycosidic connections. There are numerous beneficial health effects associated with beta-glucan.
To evaluate & compare oral glucose tolerance to Barley water and Brown rice water on type 2 diabetes. |