| CTRI Number |
CTRI/2025/03/082784 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of yava and yavak in management of madhumeh . |
|
Scientific Title of Study
|
Comparative clinical study of yava and yavaka based pathya ahara kalpana in the management of madhumeha W.S.R. to Diabetes mellitus type 2. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyoti khinchi |
| Designation |
Pg scholar |
| Affiliation |
National institute of Ayurveda |
| Address |
department of dravyaguna, national institute of ayurveda madhav villas jaipur 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
8058288238 |
| Fax |
|
| Email |
jyotikhinchi04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. sumit nathani |
| Designation |
associate professor |
| Affiliation |
National institute of Ayurveda |
| Address |
department of dravyaguna, national institute of ayurveda madhav villas jaipur 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
7995809886 |
| Fax |
|
| Email |
sumitnathani24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jyoti khinchi |
| Designation |
Pg scholar |
| Affiliation |
National institute of Ayurveda |
| Address |
departmnt of dravyaguna , national institute of ayurveda
Jaipur
RAJASTHAN
302002
India |
| Phone |
8058288238 |
| Fax |
|
| Email |
jyotikhinchi04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of dravyaguna, National institute of ayurveda madhav villas jaipur 302002 |
|
|
Primary Sponsor
|
| Name |
National institute of ayurveda |
| Address |
National institute of Ayurveda,madhav villas jaipur 302002 |
| 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 |
| Jyoti khinchi |
National institute of ayurveda |
OPDNO 19 ,7, Department of Dravyaguna,Diabetes OPD National institute of ayurveda, Jaipur 302002
Jaipur
RAJASTHAN |
8058288238
jyotikhinchi04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA |
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 | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:YAVA,50GM, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:YAVAKA,50GM, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Fasting Blood Sugar (FBS) in the range of 126-180 mg/dl, Post Prandial Blood Sugar (PPBS) in the range of 140 – 250 mg/dl. Type 2 Diabetes Mellitus Presence of cardinal symptoms of Madhumeha as described in Ayurvedic texts. |
|
| ExclusionCriteria |
| Details |
Patients of Type 1 Diabetes. Patients of Type 2 Diabetes who are on insulin therapy. Patients having any serious illness like coronary artery disease, malignancy, kidney failure, neuropathy etc.Pregnant women and lactating mother. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the objective parameters-F.B.S.,P.P.B.S., Urine - Routine and Microscopic examination, Lipid Profile, LFT, RFT from baseline value. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in the clinical symptoms of Mahdumeha
(Type 2 diabetes mellitus) |
4 week |
|
|
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 2 |
|
Date of First Enrollment (India)
|
29/03/2025 |
| 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 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
|
Madhumeh is controlled by regular and proper diet
followed by proper medicines in ayurveda
and various aahar preparations are mentioned
as pathya in which and yavaka pathya ahara kalpana are one
among them.various studies have been undertaken to observe the efficacy of yava
and yavaka indidivually but studies to compare the clinical efficacy between yavaka
and yava on madhumeha has not
been done yet. AIM : To compare
the efficacy two groups i.e yava and yavaka ahara kalpana in the
management of madhumeh. OBJECTIVE: To
conduct randomized clinical trial in order to evalute the efficacy of Yava(Hordeum vulgare linn.) and Yavaka ( Avena sativa linn.) in madhumeha Null hypothesis (H0): There is no difference between
yava and yavaka ahara kalpana
in two groups
of madhumeha patients. Alternate hypothesis
(H1): There is difference between yava and yavaka ahara kalpana
in two groups of madhumeha patients. Study design: Study type- Prospective, randomized, two arm clinical trial, Phase of clinical trial-
Phase – 2, Number of groups- Two, Number of patients - 60, Duration : 18 months
|