| CTRI Number |
CTRI/2019/06/019749 [Registered on: 18/06/2019] Trial Registered Prospectively |
| Last Modified On: |
20/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Other (Specify) [SIDDHAR YOGAM THERAPY] |
| Study Design |
Other |
|
Public Title of Study
|
CLINICAL TRIAL ON NEERIZHIVU[DIABETES MELLITUS] WITH YOGA |
|
Scientific Title of Study
|
An open labelled
non- randomized phase II comparative clinical trial to evaluate the therapeutic efficacy of SIDDHAR YOGAM THERAPY and NAAVAL PAZHA KARPAM [ SIDDHA KALPA MEDICINE-INTERNAL] for NEERIZHIVU[DIABETES MELLITUS] |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
H JESIMA BARVEEN |
| Designation |
PG Scholar |
| Affiliation |
Govt Siddha Medical College Hospital |
| Address |
GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL
DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM OP NO 4
PALAYAMKOTTAI
GOVT SIDDHA MEDICAL COLLEGE and HOSPITAL
DEPARTMENT OF SIDDHAR YOGA MARUTHUVAM OP NO 4
PALAYAMKOTTAI
PALAYAMKOTTAI
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7639886397 |
| Fax |
|
| Email |
jesimabarveen22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
A S POONGODI KANTHIMATHI |
| Designation |
PROFESSOR |
| Affiliation |
Govt Siddha Medical College Hospital |
| Address |
GOVT SIDDHA MEDICAL COLLEGE and HOSPITAL
DEPARTMENT OF SIRAPPU MARHUTHUVAM OP NO 4
PALAYAMKOTTAI
GOVT SIDDHA MEDICAL COLLEGE and HOSPITAL
DEPARTMENT OF SIRAPPU MARUTHUVAM OP NO 4
PALAYAMKOTTAI
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9865105356 |
| Fax |
|
| Email |
arunapriya1995@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
A S POONGODI KANTHIMATHI |
| Designation |
PROFESSOR |
| Affiliation |
Govt Siddha Medical College Hospital |
| Address |
GOVT SIDDHA MEDICAL COLLEGE and HOSPITAL
DEPARTMENT OF SIRAPPU MARUTHUVAM OP NO 4
PALAYAMKOTTAI
GOVT SIDDHA MEDICAL COLLEGE and HOSPITAL
DEPARTMENT OF SIRAPPU MARUTHUVAM OP NO 4
PALAYAMKOTTAI
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9865105356 |
| Fax |
|
| Email |
arunapriya1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
H JESIMA BARVEEN |
| Address |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL
PALAYAMKOTTAI
TIRUNELVELI |
| 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 |
| H Jesima Barveen |
GOVT SIDDHA MEDICAL COLLEGE AND HOSPITAL |
Government Siddha Medical College and Hospital
Dept of Siddhar Yoga Maruthuvam op no 4
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU |
7639886397
jesimabarveen22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Govt Siddha Medical College Palayamkottai |
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 |
nil |
nil |
| Intervention |
SIDDHAR YOGAM THERAPY WITH NAAVAL PAZHA CHOORANAM |
SIDDHAR YOGAM THERAPY AND
NAAVAL PAZHA CHOORANAM 1-2 GRAMS FOR 48 DAYS |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
69.00 Year(s) |
| Gender |
Both |
| Details |
patients with the symptoms of diabetes mellitus not more than 2 years are included
patient willing to give blood and urine samples before and after treatment
patient with blood sugar level of about more than 126mg/dl less than 250 mg/dl Hba1c more than 6.5 and less than 10
willing to participate in study and signing consent by fulfiling the condition of proforma are included |
|
| ExclusionCriteria |
| Details |
Age group less than 35
chronic diabeic cases for duration more than 2 years
Ischaemic heart disease
Diabetic foot and ulcer
Gestational diabetes mellitus/other specific types
Lactating mother
Chronic liver disease
chronic renal disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome is assessed by the reduction of blood sugar level after treatment |
Group I intermittent siddhar yogam therapy for 48 days
Ist sitting 40 percentage of primary symptoms will reduce
IInd sitting 80 percentage of symptoms will reduce
Group II After giving internal medicine for 48 days 50 percentage of symptoms will reduce
After giving both internal medicine and external therapy for 48 days 80 percentage of symptoms will reduce |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The outcome is assessed by the reduction of blood sugar level after treatment |
Group I intermittent siddhar yogam therapy for 48 days
Ist sitting 40 percentage of primary symptoms will reduce
IInd sitting 80 percentage of symptoms will reduce
Group II After giving internal medicine for 48 days 50 percentage of symptoms will reduce
After giving both internal medicine and external therapy for 48 days 80 percentage of symptoms will reduce |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/06/2019 |
| Date of Study Completion (India) |
03/04/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Siddha system of medicine is one of
the oldest system of medicine practiced in the south india especially in tamil
nadu and countires like srilanka, Malaysia, Singapore, and UAE. Traditionally
it is taught by the supernatural people , the siddhars who laid foundation for
this system of medicine.
In siddha system kayakarpam and yoga
practices are well explained by many siddhars especially THIRUMOOLAR. Among the
books of thirumoolar, i have choosen Asana from THIRUMOOLAR
THIRUMANTHIRAM.
Diabetes mellitus is one of the major
lifestyle disorder and non-communicable disease occurs mostly due to sedentary
lifestyle. polyuria, polyphagia, polydipsia, numbness, mood changes and
irritability, difficulty in concentration are the major symptoms seen in
patients with diabetes mellitus.
|