| CTRI Number |
CTRI/2019/07/020125 [Registered on: 09/07/2019] Trial Registered Prospectively |
| Last Modified On: |
18/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
AN OPEN CLINiCAL STUDY TO VALIDATE THE EFFECTIVENESS OF SIDDHAR YOGA THERAPY FOR THOOKAMINMAI (INSOMNIA)
|
|
Scientific Title of Study
|
PHASE II AN OPEN CLINiCAL STUDY TO VALIDATE THE EFFECTIVENESS OF SIDDHAR YOGA THERAPY FOR THE BETTER QUALITY OF SLEEP IN THOOKAMINMAI (INSOMNIA) IN ALL SEXES FROM 18 TO 65 YEARS OLD PATIENTS ATTENDING OPD OF ANNA HOSPITAL. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrGMuthu variyar |
| Designation |
Pg scholar |
| Affiliation |
Government siddha medical college Chennai |
| Address |
no-6 nsk Nagar Anna arch road Arumbakkam chennai
Post graduate department of Siddhar Yoga maruthuvam,No-6 Nsk Nagar Anna arch, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9787068669 |
| Fax |
|
| Email |
muthuvariyar11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K SAIBUDEEN |
| Designation |
Associate professor |
| Affiliation |
Government siddha medical college Chennai |
| Address |
No-6 Anna arch road,Nsk Nagar, Arumbakkam, Chennai 600106.
Post graduate department of Siddhar Yoga maruthuvam,No-6 Anna arch road,Nsk Nagar, Arumbakkam, Chennai 600106.
Chennai
TAMIL NADU
600106
India |
| Phone |
9486041993 |
| Fax |
|
| Email |
drsaibudeen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K SAIBUDEEN |
| Designation |
Associate professor |
| Affiliation |
Government siddha medical college Chennai |
| Address |
No-6 Anna arch road,Nsk Nagar, Arumbakkam, Chennai 600106.
Post graduate department of Siddhar Yoga maruthuvam, No-6 Anna arch road,Nsk Nagar, Arumbakkam, Chennai 600106.
Chennai
TAMIL NADU
600106
India |
| Phone |
9486041993 |
| Fax |
|
| Email |
drsaibudeen@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college No6 nsk Nagar Anna arch road Arumbakkam Chennai 106 |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college Chennai |
| Address |
No 6 Anna arch road NSK nagar Arumbakkam Chennai 106 |
| 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 |
| DrGMuthu Variyar |
Arignar Anna Government siddha medical college hospital |
Room 4c Siddha Division Postgraduate Department of Siddhar Yoga Maruthuvam Arignar Anna Hospital of Indian medicine Anna Arch road NSK Nagar Arumbakkam Chennai 106
Chennai
TAMIL NADU |
9787068669
muthuvariyar11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G||Mental Health, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Asanas Pranayama meditation |
Padmasana
Singasanam
Bhadrasana
Sukhasana
Paschimottasana
Yoga nidra
Savasana
PRANAYAMAM
Pooragam
Kumbagam
Resagam
DHIYANAM (MEDITATION )
Om
Duration 45 minutes for 48 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Difficulty in initiating,maintaining sleep
2.wake up morning earlier
3.insomnia last at least 3 nights per week, for 3months
4. Insomnia severity index scale score of 15 or more |
|
| ExclusionCriteria |
| Details |
1.Diabetes mellitus, prostomegaly
2.Head injury induced
3.Respiratory and cardiac failure
4 Pregnant women
5.Life threatening condition |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate mind concentration,to improve quality of mind and avoidance of takin sleep inducing pills. |
Comparing the clinical symptoms before and after the treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It is assessed by comparing the safety parameters of before and after treatment.
|
Nill |
|
|
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)
|
21/07/2019 |
| 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)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an open clinical study to validate the effectiveness of siddhar yoga therapy for thookamimai (insomnia) from above 18 years and below 65 years of male and female . yoga therapy will be given for 48days . This is non invasive , non drug type of method advocated by physicians for better mind , body and improves the quality of sleep and life |