| CTRI Number |
CTRI/2024/08/072274 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
05/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Slow Breathing Exercise] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Preventive Strategies on Physiological, Bio-chemical and Behavioral Risk factors of Cardiovascular Diseases among Adults
|
|
Scientific Title of Study
|
Efficacy of Risk Mitigation Strategies on
Physiological, Bio-chemical and Behavioral Risk factors of Cardiovascular Diseases among Adults.
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sasikala Palayan |
| Designation |
Lecturer |
| Affiliation |
Sri Ramachandra Faculty of Nursing, SRIHER |
| Address |
Department of Nursing Foundation Sri Ramachandra Faculty of Nursing
Sri Ramachandra Institute of Higher Education and Research
Chennai
TAMIL NADU
600053
India |
| Phone |
8056834686 |
| Fax |
|
| Email |
sasikalajose@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Thenmozhi |
| Designation |
Professor cum HOD |
| Affiliation |
Saveetha college of Nursing SIMATS |
| Address |
Department of Medical and Surgical Nursing
Saveetha College of Nursing
Saveetha Institute of Medical and Technical Sciences
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
8838374627 |
| Fax |
|
| Email |
thenmozhi.scon@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Thenmozhi |
| Designation |
Professor cum HOD |
| Affiliation |
Saveetha college of NursingSI MATS |
| Address |
Department of Medical and Surgical Nursing
Saveetha College of Nursing
Saveetha Institute of Medical and Technical Sciences
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
8838374627 |
| Fax |
|
| Email |
thenmozhi.scon@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Sai Sheet stamping Pvt.Ltd Geason nagar, Ayyanambakkam, Chennai-
95
|
| Zamil steel Pvt.Ltd Kocher Technology Park, Ambattur Industrial
Estate, Chennai-58
|
|
|
Primary Sponsor
|
| Name |
Sasikala Palayan |
| Address |
S1 Sai Vadan Flats No 12 first main road Thiruvengada Nagar Ambattur Chennai 600053 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mr Karthick |
Sai Sheet stamping Pvt.Ltd |
41 42 Geason nagar Ayyanambakkam Chennai
95
Chennai
TAMIL NADU |
8939864066
hr@saiweld.com |
| Mr Mukkaiyan |
Zamil steel Engineeing India Pvt Ltd |
Kocher Technology Park First cross road 2nd floor Ambattur Industrial
Estate Chennai 58
Chennai
TAMIL NADU |
9500014235
sivagurunathan@zamilsteel.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Sai Sheet Stamping Pvt Ltd |
No Objection Certificate |
| Saveetha Medical College Hospital |
Approved |
| Zamil Steel Engineering India Pvt Ltd |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Risk factors of cardiovascular diseases |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No intervention |
No intervention |
| Intervention |
Risk Mitigation strategies |
Nurse Led Education Alternate Nasal Breathing Aerobic exercise sunlight exposure once in a day for 6 months |
| Intervention |
Tab.Calciferol 60, 000 IU |
Tab.Calciferol 60, 000 IU per week for 6-8 weeks oral route |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Adults between the ages of 21-60 years.
2 Adults who have mild, moderate level of CVD risk
3 Adult who have deficient and insufficient vitamin D3 level
4 Adults who are willing to participate.
|
|
| ExclusionCriteria |
| Details |
1 Adults who are pregnant, skin disorders ( Such as skin burns, Psoriasis etc)
2 Adults who are in steroids and thiazide diuretics.
3 Adults who are already with Vitamin D3 supplements.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Level of risk cardiovascular diseases will be reduced after 24 months of intervention |
24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in behaviour towards prevention of risk on cardiovascular diseases |
6 months |
| Pysiological risk factors towards cardiovascular diseases will be reduced after the intervention |
6 months |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
19/08/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a non randomized control trail multicentric, comparing the efficacy of Risk Mitigation Strategies such as Nurse led education on prevention of risk factors of cardiovascular diseases, alternative nasal breathing, aerobic exercise, sunlight exposure and vitamin D3 supplementation 60000IU per week for 6-8 weeks. The study intervention will be divided into experiemental arm 1 with risk mitigation strategies and arm 2 with supplementaion of vitamin D3. The primary outcome of the study will be measured useing biochemical parameters such as lipid profile, FBS and vitamin D3 level and the secondary outcome will be measure using self structured behavious modification scale and bio physiological parameters such as BMI, Blood pressure and waist circumferences after 6 months. |