| CTRI Number |
CTRI/2020/03/024223 [Registered on: 24/03/2020] Trial Registered Prospectively |
| Last Modified On: |
14/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
EFFICACY OF SIDDHAR YOGA THERAPY AND MATHUMEGA CHOORNAM FOR MADHUMEGAM (DIABETES MELLITUS TYPE II) |
|
Scientific Title of Study
|
PHASE II An Open Comparative Study To Validate The Effectiveness Of Siddhar Yoga Therapy and Internal MATHUMEGA CHOORANAM FOR MADHUMEGAM (DIABETES MELLITUS TYPE II) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ANAND R |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate
Department of Siddhar Yoga Maruthuvam
Government Siddha Medical College
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
India
600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9786087238 |
| Fax |
|
| Email |
dranandbsms994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SAIBUDEEN K |
| Designation |
Head of the Department |
| Affiliation |
Government Siddha Medical College |
| Address |
Department of Siddhar Yoga Maruthuvam
Government Siddha Medical College
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
India
600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9486041993 |
| Fax |
|
| Email |
drsaibudeen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ANAND R |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate
Department of Siddhar Yoga Maruthuvam
Government Siddha Medical College
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
India
600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9786087238 |
| Fax |
|
| Email |
dranandbsms994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
India
600106 |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
Government Siddha Medical College
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
India
600106 |
| 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 |
| Dr ANAND R |
Arignar Anna Government Hospital for Indian Medicine |
op no S3
Department of Siddhar Yoga Maruthuvam
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
India
600106
Chennai
TAMIL NADU |
9786087238
dranandbsms994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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 |
| Comparator Agent |
MATHUMEGA CHOORNAM |
5 grams of Mathumega Chooranam with hot water is administered twice a day with yoga asanas, pranayama, meditation for 48 days |
| Intervention |
Yoga Therapy,Pranayama,Medidation |
Yoga asanas,Pranayama and Meditation for 45 minutes in morning every day for 48 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subject with age 30-60 years
Both male and female
Nocturia
Blood glucose(F) – 120mg/dl to 160 mg/dl
Blood glucose(pp) - 180mg/dl to 280 mg/dl
HBA1C -6.5% to 9%
|
|
| ExclusionCriteria |
| Details |
Insulin Dependent Diabetes Mellitus
HbA1c >9
Cardiovascular disease
Diabetic nephropathy
Diabetic retinopathy
Hypertension
Pregnant women and lactating mothers
T.B affected individuals
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mainly assessed by Reduction in blood sugar and HbA1C level (atleast 5% to 10% reduce)
Reduction in clinical symptoms.
|
48 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess cholesterol profile before and after treatment |
48 days |
|
|
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)
|
30/03/2020 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is Phase II an open comparative study to
validate the effectiveness of siddhar yoga therapy and internal mathumega choornam for madhumegam(diabetes
mellitus type II).This treatment administered comparatively yoga therapy for one group and yoga with mathumega choornam one group for 48 days.During the trail all the study related data will be recorded and documented.After the completion of trail all data will be analysis statistically.
|