| CTRI Number |
CTRI/2017/06/008825 [Registered on: 13/06/2017] Trial Registered Prospectively |
| Last Modified On: |
08/06/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
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Public Title of Study
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“Effect of Yoga on Cardiovascular & Biochemical parameters in Prediabetes |
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Scientific Title of Study
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“EFFECT OF INTEGRATED APPROACH OF YOGA THERAPY ON CAROTID INTIMA MEDIA THICKNESS , HEART RATE VARIABILITY & BIOCHEMICAL PARAMETERS IN PREDIABETES†|
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| Nil |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Saboo |
| Designation |
Assistant Professor |
| Affiliation |
RUHS college of medical sciences |
| Address |
RUHS college of medical sciences
jaipur
Jaipur
RAJASTHAN
302033
India |
| Phone |
9928053007 |
| Fax |
09928053007 |
| Email |
nehasaboo8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sudhanshu Kacker |
| Designation |
Professor |
| Affiliation |
RUHS college of medical sciences |
| Address |
RUHS college of medical sciences
jaipur
Jaipur
RAJASTHAN
302033
India |
| Phone |
|
| Fax |
|
| Email |
sudhanshukacker@gmail.com |
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Details of Contact Person
Public Query
|
| Name |
Neha Saboo |
| Designation |
Assistant Professor |
| Affiliation |
RUHS college of medical sciences |
| Address |
RUHS college of medical sciences
jaipur
Jaipur
RAJASTHAN
302033
India |
| Phone |
9928053007 |
| Fax |
09928053007 |
| Email |
nehasaboo8@gmail.com |
|
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Source of Monetary or Material Support
|
| Rajasthan university of Health Sciences,kumba marg,pratap nagar ,sector-18,jaipur |
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Primary Sponsor
|
| Name |
RUHS college of medical sciences jaipur |
| Address |
RUHS college of medical sciences
jaipur |
| Type of Sponsor |
Other [] |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| Rajasthan university of health sciences |
Rajasthan university of health sciences |
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DRNEHA SABOO |
RUHS COLLEGE OF MEDICAL SCIENCES AND JAIPURIA HOSPITAL |
RUHS COLLEGE OF MEDICAL SCIENCES,JAIPUR
Jaipur
RAJASTHAN |
9928053007
nehasaboo8@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RUHS ETHICS COMMITTEE |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
prediabetes, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONTROL |
CONTROL WHO ARE PREDIABETICS NOT USE YOGA INTERVENTION |
| Intervention |
yoga |
The Integrated Approach of Yoga Therapy includes Prayer, Omkar recitation, yoga postures (asanas), breathing (pranayama), Shavasana ,Counseling and diet will also be part of the programme.
Yoga will be used as an interventional therapy in this study. Yoga training will be given by certified yoga instructor and all investigations shall be checked on monthly basis. These sessions will last for approximately 45 minutes five times a week over a period of one year. All the cases will be given cd of integrated approach of yoga therapy & e message and phone calls on daily basis to check the compliance of patients. Evaluation will be done quarterly basis. The Integrated Approach of Yoga Therapy includes Prayer, Omkar recitation, yoga postures (asanas), breathing (pranayama), Shavasana ,Counseling and diet will also be part of the programme.
Yoga will be used as an interventional therapy in this study. Yoga training will be given by certified yoga instructor and all investigations shall be checked on monthly basis. These sessions will last for approximately 45 minutes five times a week over a period of one year. All the cases will be given cd of integrated approach of yoga therapy & e message and phone calls on daily basis to check the compliance of patients. Evaluation will be done quarterly basis.
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Ambulatory participants aged 30 to 50years
2. All subjects with Fasting blood glucose level of: 110 to 125 mg/dL (6.1 mM/L to 6.9 mM/L) & Two hour glucose tolerance test , blood sugar level of 140 to 199 mg/dL (7.8 to 11.0 mM) ,hemoglobin A1c (HbA1c) levels 5.5% to 6.5% any of the above two parameters will include .
3. no personal history of cardiovascular disease, no cardiovascular disease in the first-degree relatives, and serious illness requiring admission to hospital in the past year
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| ExclusionCriteria |
| Details |
1. Fasting blood glucose < 100mg/dl & >126 mg/dl , OGTT < 140 & >200 mg/dl glycated hemoglobin < 5.5% & > 6.5% systolic blood pressure ≥ 160 mmhg or diastolic blood pressure ≥ 100 mmhg
2. Abnormal liver function test (alanine aminotransfer¬ase [ALT] or aspartate aminotransferase [AST] ≥ 2.5-fold the upper normal limit
3. Alcoholic individuals (weekly alcohol consumption ≥ 140 g).
4. Renal dysfunction, diabetic retinopathy and neuropathy and any other major complications.
5. Those being treated with steroid or non-steroidal anti-inflammatory medication
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Method of Generating Random Sequence
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Method of Concealment
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Blinding/Masking
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Primary Outcome
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| Outcome |
TimePoints |
| 4. Practice of comprehensive yogic breathing had beneficial effects on cardiac autonomic functions in prediabetes. Since cardiac dysfunction has been implicated in sudden cardiac death in diabetes, this finding may translate to practice of yogic breathing program being useful in delaying sudden cardiac death. |
two year |
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Secondary Outcome
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| Outcome |
TimePoints |
| 6. Studies has been established practice of comprehensive yogic breathing program significantly improves physical, psychological, and social domains, and total quality of life. In view of the existing knowledge and yoga being a cost ‑effective technique without side effects, it appears appropriate to incorporate yoga/meditation for primary and secondary prevention of cardiovascular disease. |
2 years |
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Target Sample Size
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Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
17/07/2017 |
| 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 |
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Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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None yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
Title of the Research Project “EFFECT OF INTEGRATED APPROACH OF YOGA THERAPY ON CAROTID INTIMA MEDIA THICKNESS , HEART RATE VARIABILITY & BIOCHEMICAL PARAMETERS IN PREDIABETES†Objectives- The objectives of the study are as follows: - 1. To study effect of yoga on carotid artery intima media thickness as an early indicator of atherosclerosis in prediabetes. 2. To study effect of yoga on heart rate variability in prediabetes. 3. To study effect of yoga on biochemical parameters like blood glucose, glycated HbA1C & serum lipid profile in prediabetes. 4. To evaluate the effect of yoga on prediabetes and use it as a tool for primary prevention. Design of the study— PROSPECTIVE COMPARITIVE STUDY Mode of Selection of Subjects: Source of data 1. First degree relatives of diabetics 2. Newly diagnosed cases of prediabetecs 3. Patients attending general medicine outpatient section Sample size: 250 As the prevalence of diabetes in India is 8% taking it as a reference the sample size is calculated using the appropriate size formula z2pq/d2 where p & q were taken as .08 and .92 to get the maximum sample size with 5% permissible error(precision ) and 10% non response rate the desired sample size is 125 with 95% confidence interval. Methodology: Interventions The Integrated Approach of Yoga Therapy includes Prayer, Omkar recitation, yoga postures (asanas), breathing (pranayama), Shavasana ,Counseling and diet will also be part of the programme. Yoga will be used as an interventional therapy in this study. Yoga training will be given by certified yoga instructor and all investigations shall be checked on monthly basis. These sessions will last for approximately 45 minutes two times a week over a period of one year. All the cases will be given cd of integrated approach of yoga therapy & e message and phone calls on daily basis to check the compliance of patients. Evaluation will be done quarterly basis. Cardiovascular Parameters HRV PARAMETERS Biochemical parameters Expected Benefits from the study: However, this type of intervention study has not been done in prediabetes of Rajasthan population . Therefore, this case control intervention will determine the efficacy of yoga on Prediabetes in the state of Rajasthan
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