| CTRI Number |
CTRI/2025/02/080114 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
05/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare Barley and Emmer long Wheat as diet in the management of Diabetes. |
|
Scientific Title of Study
|
A Comparitive study to evaluate the efficacy of Barley(Hordeum vulgare,L.) and Emmer Long Wheat(Triticum dicoccum,Schrank.) as pathya in the management of Prameha vis-a-vis Type 2 Diabetes Mellitus |
| 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 Noorul Hadiya |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College and Hospital,Mysuru |
| Address |
Department of Swasthavritta and Yoga, Government Ayurveda Medical College and Hospital,Vishweshwarayya Circle,Devaraja Mohalla,Mandi Mohalla,Mysuru-570001,Karnataka
Mysore
KARNATAKA
570001
India |
| Phone |
7022084610 |
| Fax |
|
| Email |
noorulhadiya2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudheendra G Nawale |
| Designation |
Professor |
| Affiliation |
Government Ayurveda Medical College and Hospital,Mysuru |
| Address |
Department of Swasthavritta and Yoga, Government Ayurveda Medical College and Hospital,Vishweshwarayya Circle,Devaraja Mohalla,Mandi Mohalla,Mysuru-570001,Karnataka
Mysore
KARNATAKA
570001
India |
| Phone |
9341061821 |
| Fax |
|
| Email |
sudhi130207t@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudheendra G Nawale |
| Designation |
Professor |
| Affiliation |
Government Ayurveda Medical College and Hospital,Mysuru |
| Address |
Department of Swasthavritta and Yoga, Government Ayurveda Medical College and Hospital,Vishweshwarayya Circle,Devaraja Mohalla,Mandi Mohalla,Mysuru-570001,Karnataka
Mysore
KARNATAKA
570001
India |
| Phone |
9341061821 |
| Fax |
|
| Email |
sudhi130207t@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College and Hospital,Vishweshwarayya Circle,Devaraja Mohalla,Mandi Mohalla,Mysuru-570001,Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Noorul Hadiya |
| Address |
Department of Swasthavritta and Yoga, Government Ayurveda Medical College and Hospital,Vishweshwarayya Circle,Devaraja Mohalla,Mandi Mohalla,Mysuru-570001,Karnataka |
| 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 Noorul Hadiya |
Government Ayurveda Medical College and Hospital, Mysore. |
Room 12 Department of Swasthavritta and Yoga, Government Ayurveda Medical College and Hospital,Vishweshwarayya Circle,Devaraja Mohalla,Mandi Mohalla,Mysuru-570001,Karnataka
Mysore
KARNATAKA |
7022084610
noorulhadiya2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Ayurveda Medical College and Hospital Mysuru |
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: PRAMEHAH, |
|
|
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: Pathya:60 grams of each packet of powdered Hordeum vulgare, L . will be given to make 2 rotikas for 1 annakala for 12 weeks
Pathya:60 grams of each packet of powdered Triticum dicoccom,Schrank. will be given to make 2 rotikas for 1 annakala for 12 weeks, Apathya:- |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects of the age group between 25-55 years fulfilling the diagnostic criteria will be selected for the study.
2. Diagnosed cases of diabetes within 5 years of onset. |
|
| ExclusionCriteria |
| Details |
1. Diagnosed cases of Diabetic neuropathy, nephropathy and retinopathy.
2. Type 1 Diabetes mellitus.
3. Pregnant or lactating women.
4. Already diagnosed cases of chronic systemic illness such as cancer, rheumatoid arthritis,
AIDS, etc.
5. Diabetic subjects having,
Fasting Plasma Glucose greater than 200 mg/dl
Plasma Glucose in random sample or 2hrs after a 75g glucose load greater than 350 mg/dl
HbA1c greater than 10 percent |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Barley and Emmer Long wheat as pathya in reducing blood glucose levels to normal levels as per ADA |
91st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Barley and Emmer Long wheat as pathya in relieving other associated symptoms of Diabetes Mellitus like increased frequency of micturition increased thirst |
91st day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/03/2025 |
| 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="1"
Months="6"
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
|
Prameha is a disease characterised by symptoms like Prabhuta avila mutrata mainly caused by nidana which predominantly increases Kapha dosha such as Navanna pana Dadhi sevana etc. It is one among Santarpana janya vikara and Ashta mahagada. Now a days due to changing Ahara prameha is becoming a dreadful disorder. Therefore considering apathya ahara as a major cause of disease manifestation avoiding the same and indulging in pathya ahara plays an important role in chikitsa. Prameha can be corelated to Diabetes mellitus in contemporary science. WHO defines Diabetes is a chronic metabolic disease characterised by elevated levels of blood glucose which leads overtime to serious damage to the heart blood vessels eyes kidney and nerves. Diabetic association of India under the IDF estimated that the global prevalence of Diabetes has reached 10.5 percent. Available treatment protocols in contemporary science include advice about dietary and lifestyle modification in initial stages followed by initiation of oral anti diabetic drugs and insulin therapy if needed in subsequent stages. Arogyam Bhojanadinam health is dependent on Ahara. The difference lies in hita and Ahita of it. It is possible to make a person disease free with just proper Ahara. Pathya is mentioned as synonym of Chikitsa in Charaka Samhita.Many protocols have been standardized for the treatment of prameha but pathya ahara sevana has its importance in Prameha as it is considered to be a Yapya Vyadhi. Yava and Godhuma are Nitya sevaniya ahara and are considered as Pathya in Prameha Chikitsa. Barley Hordeum vulgare L contains wide ranging nutrients such as minerals vitamins etc. It has various health benefits such as anti diabetic anti obesity properties etc. Emmer long wheat Triticum dicoccom Schrank has low glycemic index value and high satiety value which make it particularly suitable for diabetes. As both the species having the anti diabetic properties the present study is to compare the efficacy of each species and the role of pathya sevana in the management of Prameha. |