| CTRI Number |
CTRI/2020/03/024337 [Registered on: 30/03/2020] Trial Registered Prospectively |
| Last Modified On: |
13/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
breathing exercises (pranayama) in premenstrual syndrome |
|
Scientific Title of Study
|
Effect of Pranayama on Baroreflex Sensitivity and Cognition in Women with Premenstrual Syndrome – A randomized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jothi Marie Feula A |
| Designation |
Senior Resident |
| Affiliation |
JIPMER |
| Address |
Senior Resident,
Department of Physiology,
JIPMER,
Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8870815320 |
| Fax |
|
| Email |
dr.feula@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jothi Marie Feula A |
| Designation |
Senior Resident |
| Affiliation |
JIPMER |
| Address |
Senior Resident,
Department of Physiology,
JIPMER,
Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8870815320 |
| Fax |
|
| Email |
dr.feula@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jothi Marie Feula A |
| Designation |
Senior Resident |
| Affiliation |
JIPMER |
| Address |
Senior Resident,
Department of Physiology,
JIPMER,
Puducherry.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8870815320 |
| Fax |
|
| Email |
dr.feula@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
JIPMER, Puducherry |
| 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 |
| Dr Jothi Marie Feula A |
JIPMER |
8505, Cardiovascular research lab, Department of Physiology,
JIPMER,
Puducherry - 605 006
Pondicherry
PONDICHERRY |
8870815320
dr.feula@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for interventional studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers with and without Premenstrual syndrome |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
sham pranayama |
8 weeks of non pranayamic breathing techniques |
| Intervention |
structured pranayama technique |
Pranayama will be given for 8 weeks duration (5 days per week). The training will be given by a qualified and trained yoga instructor. Subjects will be practicing pranayama under the supervision of the trainer for the 1st week, following which they will be advised to practice at home and their compliance will be confirmed by a single session visit to ACYTER around the 3rd week of intervention and regular telephonic conversation for rest of the sessions. Each session will last for approximately 20 minutes duration, which includes
1. Chandra pranayama (9 cycles)
2. Nadi Shodhana (9 cycles):
3. Pranava Pranayama (5 minutes)
4. Bhramari (5 cycles)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
PMS Group:
1. Women of 18 to 45 years of age with regular 21 to 35 days menstrual cycle of duration 3 to 7 days for at least 6 consecutive months and are diagnosed as moderate to severe PMS by Premenstrual syndrome screening tool (PSST) questionnaire.
Non PMS Group:
1. Women of 18 to 45 years of age with regular 21 to 35 days menstrual cycle of duration 3 to 7 days for at least 6 consecutive months and are diagnosed as no PMS by Premenstrual syndrome screening tool (PSST) questionnaire.
|
|
| ExclusionCriteria |
| Details |
1. Women diagnosed as Premenstrual dysphoric disorder (PMDD) by PSST questionnaire
2. Women with irregular menstrual cycle
3. Usage of Oral contraceptive pills
4. Regular physical exercises
5. Women already practicing yoga
6. History of depression and other psychological disorders
7. Hypertension
8. Endocrine and metabolism disorders
9. Smoking, alcoholism
10. On medications that affect autonomic nervous system & cognition
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Beneficial effects of pranayama on sympathovagal balance and cognition in women with premenstrual syndrome |
The effects of pranayama will be assessed at the end of 8 weeks of pranayama intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Baroreflex sensitivity and cognition is reduced in premenstrual syndrome |
before and after 8 weeks of pranayama intervention |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2020 |
| Date of Study Completion (India) |
24/09/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study was aimed at assessing the effects of pranayama on baroreflex sensitivity and cognition in women with premenstrual syndrome. Approved by JIPMER scientific advisory committee and Institute Ethics committee. The study was started in July 2020 and was completed in September 2020 |