| CTRI Number |
CTRI/2023/03/050342 [Registered on: 03/03/2023] Trial Registered Prospectively |
| Last Modified On: |
07/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The effectiveness of ayurvedic treatment as an add on therapy will be assessed in patients of diabetes of 5 to 10 year duration. |
|
Scientific Title of Study
|
An observational study on the effectiveness of ayurvedic treatment as an add on therapy in maintaining ojas and improving quality of life in type 2 diabetes mellitus patients of 5 to 10 year duration. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pradeep K |
| Designation |
Associate Professor |
| Affiliation |
Govt. Ayurveda College Thripunithura. |
| Address |
Department of Kriyasarira
Govt. Ayurveda Colllege
Thripunithura.
Govt. Ayurveda College Thripunithura, Ernakulam.
Ernakulam
KERALA
682301
India |
| Phone |
9846606351 |
| Fax |
|
| Email |
drpradeep601@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep K |
| Designation |
Associate Professor |
| Affiliation |
Govt. Ayurveda College Thripunithura. |
| Address |
Dept. of Kriyasarira
Govt. Ayurveda College
Thripunithura.
Govt. Ayurveda College, Thripunithura, Ernakulam.
Ernakulam
KERALA
682301
India |
| Phone |
9846606351 |
| Fax |
|
| Email |
drpradeep601@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep K |
| Designation |
Associate Professor |
| Affiliation |
Govt. Ayurveda College Thripunithura. |
| Address |
Dept. of Kriyasarira
Govt. Ayurveda College
Thripunithura.
Govt. Ayurveda College
Thripunithura
Ernakulam.
Ernakulam
KERALA
682301
India |
| Phone |
9846606351 |
| Fax |
|
| Email |
drpradeep601@gmail.com |
|
|
Source of Monetary or Material Support
|
| directorate of ayurveda medical education/AYUSH department
Ayurveda Bhavan
Trivandrum |
|
|
Primary Sponsor
|
| Name |
directorate of ayurveda education/AYUSH department |
| Address |
directorate of ayurveda medical education, ayurveda bhavan, trivandrum |
| Type of Sponsor |
Government funding agency |
|
|
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 Pradeep K |
Govt. Ayurveda College Thripunithura |
Govt Ayurveda College
puthiyakavu, thripunithura
Ernakulam
KERALA |
9846606351
drpradeep601@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are competent.
2. Patient enrolment based on case history( individuals with 5-10 years history of T2DM)
3. Patients of either sex (male or female)
4. Age group- 40-60 years.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with history of other systemic illness
2. Declined to participate
3. Pregnant or nursing patients
4. Smokers
5. Patients suffering from type-1 diabetes mellitus (T1DM)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effectiveness of ayurveda treatment as an add on therapy in maintaining ojas and improving quality of life in type 2 diabetes mellitus patients of 5- 10 year duration can be assessed |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| variations of immunity profile of both groups can be studied. |
one year |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
05/03/2023 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Impact of non-communicable diseases on immunity and Ojas focussing on type 2 Diabetes Mellitus –A scoping review,
available at https://
keralajournalofayurveda.org/index.php/kja/
open-access-policy
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Sometimes combining conventional and traditional medicines improved the effectiveness of treatment. Its essential to develop a cohesive and integrative approach to health care services. It will benefit individuals seeking the right care from the right practitioner at the right time. This study will help to explore the advantages of use of ayurvedic medicine along with other conventional treatments. |