| CTRI Number |
CTRI/2017/08/009307 [Registered on: 09/08/2017] Trial Registered Prospectively |
| Last Modified On: |
08/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of slow breathing on heart functions in pregnant women with depressive symptoms. |
|
Scientific Title of Study
|
Effects of slow pranayamas on cardiac autonomic functions in pregnant women with depressive symptoms – A
randomized control trial.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PGRMC - 27.10.2016/14 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shah Ziinkal Atul |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of Physiology,
1st Floor, JIPMER academic center, JIPMER
Pondicherry
PONDICHERRY
6005006
India |
| Phone |
8524856953 |
| Fax |
|
| Email |
zziina90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pravati Pal |
| Designation |
Professor |
| Affiliation |
JIPMER |
| Address |
Department of Physiology,
1st Floor, JIPMER academic center, JIPMER
Pondicherry
PONDICHERRY
6005006
India |
| Phone |
9360682406 |
| Fax |
|
| Email |
drpravatipal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shah Ziinkal Atul |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of Physiology,
1st Floor, JIPMER academic center, JIPMER
Pondicherry
PONDICHERRY
6005006
India |
| Phone |
8524856953 |
| Fax |
|
| Email |
zziina90@gmail.com |
|
|
Source of Monetary or Material Support
|
| JIPMER Intramural grant, JIPMER, Dhanvantri nagar, Puducherry - 605006 |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
Dhanavantri Nagar |
| 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 |
| Dr Shah Zinkal Atul |
JIPMER |
Department of Physiology, 1st floor, JIPMER academic center, JIPMER campus
Pondicherry
PONDICHERRY |
8524856953
zziina90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human Studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal Pregnant females with depressive symptoms (not with diagnosis of Major Depressive Disorder) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No additional Treatment |
The controls will receive the usual Antenatal Care. |
| Intervention |
Slow Pranayamas |
A set of slow pranayamas (Anulom-Vilom, Chandranadi, Bhramari, Sheetali) along with free hand exercises and shavashana lasting for 25 mins. To be performed daily for 8 weeks. Along with the usual Antenatal care. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women of 12-15 weeks of gestation.
Women with depressive symptoms as defined by (i) Edinburgh Postnatal Depression Scale (EPDS) scores 1- 9; and (ii) those with EPDS scores 9 or more and less than 19, but current clinical depression is ruled out by Psychiatrist by use of Mini International Neuropsychiatric Interview (MINI 6.0).
Able to read and understand English or Tamil. |
|
| ExclusionCriteria |
| Details |
Pregnant women diagnosed with major depressive disorder.
Known case of psychiatric illness including depression needing pharmacological treatment.
Past history of depression or maniac episode.
Known cases of diabetes. Known renal disease.
Known cases of hypertension, pre-eclempsia.
Known cases cardiac disorders.
Having multiple pregnancies.
History of previous pregnancy loss due to known single gene defects, chromosomal disorders, intrauterine infections, in vitro fertilization pregnancy, previous history of intra uterine growth retardation.
Known maternal structural abnormalities like kyphosis/ scoliosis.
Women on any medications except for nutritional supplements.
Women undergoing yoga in past one month. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Low-frequency to high frequency (LF-HF)
BRS
Deep Breathing Difference
Heart rate and Blood Pressure Response to Standing
Blood Pressure Response to Isometric Hand-grip
Edinburgh postnatal depression scale.
Perceived stress scores.
|
start and end (8 weeks) of study
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Nor-epinephrine
hs-CRP
IL-6 |
start and end (8 weeks) of study
|
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
14/08/2017 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized parallel group open label trail comparing the effect of slow pranayamas, for 8 weeks in 70 pregnant females with depressive symptoms, compared with 70 controls receiving standard antenatal care, on cardiac autonomic functions to be conducted in JIPMER, Puducherry, India. All the primary and secondary outcomes will be measured at end of 8 weeks in both subjects and controls |