| CTRI Number |
CTRI/2023/10/058187 [Registered on: 03/10/2023] Trial Registered Prospectively |
| Last Modified On: |
27/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess the effect of Yava Mantha as a pathya in the management of Prameha (Type 2 Diabetes mellitus). |
|
Scientific Title of Study
|
A single arm clinical study to evaluate the effect of Yava Mantha as a Pathya in the management of Prameha. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VdKajal Dhondba Morande |
| Designation |
M.D. Scholar Swasthavritta |
| Affiliation |
MAMs Sumatibhai Shah Ayurveda Mahavidyalaya,Hadapsar,Pune. |
| Address |
OPD NO.4,Department of Swasthavritta,Sane Guruji Arogya Kendra,Malwadi,Hadapsar. Department of Swasthavritta,MAMs Sumatibhai Shah Ayurveda Mahavidyalaya,Hadadpsar,Pune 28.
Pune
MAHARASHTRA
411028
India |
| Phone |
8788332780 |
| Fax |
|
| Email |
kajalmorande15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRoma Gangawane |
| Designation |
Asst. Prof. of Department of Swasthavritta and Yoga |
| Affiliation |
MAMs Sumatibhai Shah Ayurveda Mahavidyalaya,Hadapsar,Pune. |
| Address |
OPD NO.4,Department of Swasthavritta,Sane Guruji Arogya Kendra,Malwadi,Hadapsar. Department of Swathavritta,MAMs Sumatibhai Shah Ayurveda Mahavidyalaya,Hadapsar,Pune 28.
Pune
MAHARASHTRA
411028
India |
| Phone |
9822007402 |
| Fax |
|
| Email |
roma.gangawane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRoma Gangawane |
| Designation |
Asst. Prof. of Department of Swasthavritta and Yoga |
| Affiliation |
MAMs Sumatibhai Shah Ayurveda Mahavidyalaya,Hadapsar,Pune. |
| Address |
OPD NO.4,Department of Swasthavritta,Sane Guruji Arogya Kendra,Malwadi,Hadapsar. Department of Swathavritta,MAMs Sumatibhai Shah Ayurveda Mahavidyalaya,Hadapsar,Pune 28.
Pune
MAHARASHTRA
411028
India |
| Phone |
9822007402 |
| Fax |
|
| Email |
roma.gangawane@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Swasthavritta and Yoga, Sane Guruji Arogya Kendra,Malwadi,Hadapsar,Pune 28. |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
Department of Swasthavritta and Yoga, Sane Guruji Arogya Kendra,Malwadi,Hadapsar,Pune 28. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Vd Kajal Dhondba Morande |
Sane Guruji Arogya Kendra,Malwadi,Hadapsar |
OPD NO.4,Department of Swasthavritta and Yoga, Sane Guruji Arogya Kendra, Malwadi Hadapsar,Pune 28.
Pune
MAHARASHTRA |
8788332780
kajalmorande15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAMs Sumatibhai Shah Ayurveda Mahavidyalaya and Sane Guruji Arogya Kendra |
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:Yava Mantha as a Pathya Ahara will be given for 90 days as a intervention in the management of Prameha.The efficacy of Yava Mantha will be evaluated by observing the patient through subjective and objective criteria at regular interval 0,30,60,90 days follow up., Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
A known Type -2 Diabetes Mellitus patient on treatment from 6 months
showing symptoms of Prameha.
Patient with fasting blood sugar >126 mg/dl -180mg/dl and post prandial blood
sugar 200-250 mg/dl
Patient having HbA1C >6.4mg/dl |
|
| ExclusionCriteria |
| Details |
Diabetes Mellitus Type-I and those who are under insulin therapy.
Pregnant and lactating mothers.
Patients with acute complications like Ketoacidosis and infections like
gangrene.
Patients with chronic complications like Nephropathy, Neuropathy and
Retinopathy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
A clinical study to evaluate the effect of Yava Mantha in Prameha.
The parameters of efficacy of Yava Mantha will be evaluate by observing the patient through subjective & objective criteria at regular intervals 0th,30th,60th,90th days follow up. The relief of sign & symptoms of Prameha will be analyzed with the help of Five point likert scale. |
The parameters of efficacy of Yava Mantha will be evaluate by observing the patient through subjective & objective criteria at regular intervals 0th,30th,60th,90th days follow up. The relief of sign & symptoms of Prameha will be analyzed with the help of Five point likert scale. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome will be to explore & promote Krutanna Kalpana mention in Ayurveda Samhita. |
The Yava Mantha will be given for 90 days. Patient will be assessed on 0th,30th,60th,90th day of treatment. Total duration of study 90 days. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/10/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 clinical study to evaluate the effect of Yava Mantha as a Pathya in the management of Prameha.The parameters of efficacy of Yava Mantha will be evaluated by observing the patient through subjective and objective criteria at regular intervals 0,30,60,90 days follow up. The relief of signs and symptoms of Prameha will be analyzed with the help of Five point likert scale. This will be done with help of kitchen ingredient like Yava as a Pathya.
|