| CTRI Number |
CTRI/2018/04/013163 [Registered on: 11/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
03/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effectiveness of yogam therapy in the management of diabetes mellittus |
|
Scientific Title of Study
|
Preclinical and comparative clinical study of Maruthampattai kudineer and yogam therapy in the management of Madhumegam(Type II 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 |
Vinubharathi B |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Ayothidass pandithar hospital, National Institute of Siddha, Tambaram sanatorium, Chennai.
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9597274326 |
| Fax |
|
| Email |
vinujuny21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
N J Muthukumar |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Ayothidass pandithar hospital, National Institute of Siddha, Tambaram sanatorium, Chennai.
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962006843 |
| Fax |
|
| Email |
njmuthu@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
N J Muthukumar |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Ayothidass pandithar hospital, National Institute of Siddha, Tambaram sanatorium, Chennai.
TAMIL NADU
600047
India |
| Phone |
9962006843 |
| Fax |
|
| Email |
njmuthu@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
B Vinubharathi |
| Address |
Ayothidass pandithar hospital, National Institute of Siddha, Tambaram sanatorium, Chennai. |
| 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 |
| B Vinubharathi |
Sirappu maruthuvam OPD |
Ayothidass pandithar hospital, National Institute of Siddha, Tambaram sanatorium, Chennai.
Kancheepuram
TAMIL NADU |
9597274326
vinujuny21@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 |
Patient with fasting blood sugar less than 150 mg/dl, post postprandial less than 250 mg/dl and Hba1c less than 6 to 8 , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Maruthampattai Kudineer (internal medicine) |
Maruthampattai kudineer is a polyherbal formulation in a dosage of 60 ml (b.d) for 90 days |
| Comparator Agent |
Yogam therapy |
Suriyanamaskaram
Bavanamuthasanam
Halasanam
Pujagasanam
vakrasanamam |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Symptoms of polyuria, polyphagia, nocturia, polydypsia.
2. Blood glucose level: fasting blood glucose- less than 150 mg/dl, postprandial level less than 250 mg/dl and Hba1c less 6 to 8.
3. Non insulin dependent diabetes mellitus. |
|
| ExclusionCriteria |
| Details |
Blood glucose level: fasting blood glucose- less than 151 mg/dl, postprandial level greater than 250 mg/dl and Hba1c above 8.1
insulin dependent diabetes mellitus.
patient with diabetic complication
diabetic foot,retinopathy etc.
any other serious systemic illness
pregnancy and lactation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the changes in the HbA1c |
1 - 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the changes in fasting and postprandial blood glucose level |
1-90 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 |
|
Date of First Enrollment (India)
|
28/12/2017 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
clinical trial to study the effectiveness of yogam in madhumegam patients |