| CTRI Number |
CTRI/2021/08/035666 [Registered on: 13/08/2021] Trial Registered Prospectively |
| Last Modified On: |
12/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study on effectiveness of Bhramari pranayama in prevention of perimenopausal syndrome. |
|
Scientific Title of Study
|
A single arm clinical study on effectiveness of Bhramari Pranayama in prevention of perimenopausal syndrome. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashwini Marotirao Pargewar |
| Designation |
M.D.Scholar Swasthavritta |
| Affiliation |
Sumatibhai shah ayurved Mahavidyalaya |
| Address |
OPD no.4 Department of Swasthavritta,sane guruji Arogya kendra Malawadi Hadapsar pune Maharashtra
411028
India
OPD no.4 Department of Swasthavritta,sane guruji Arogya kendra Malawadi Hadapsar pune Maharashtra
411028
India
Pune
MAHARASHTRA
431709
India |
| Phone |
7620370491 |
| Fax |
|
| Email |
ashupargewar271993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Ujwale |
| Designation |
HOD department of Swasthavritta and Yoga |
| Affiliation |
Sumatibhai shah ayurved Mahavidyalaya Hadapsar pune |
| Address |
OPD no.4 Department of Swasthavritta,sane guruji Arogya kendra Malawadi Hadapsar pune Maharashtra
411028
Pune
MAHARASHTRA
411028
India |
| Phone |
9922008027 |
| Fax |
|
| Email |
ujwale_rs@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRamesh Ujwale |
| Designation |
HOD department of Swasthavritta and Yoga |
| Affiliation |
Sumatibhai shah ayurved Mahavidyalaya |
| Address |
OPD no.4 Department of Swasthavritta,sane guruji Arogya kendra Malawadi Hadapsar pune Maharashtra
411028
Malawadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9922008027 |
| Fax |
|
| Email |
Ujwale_rs@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Swasthavritta and Yoga, Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar, Pune. |
|
|
Primary Sponsor
|
| Name |
Sane guruji Arogya kendra |
| Address |
Sane Guruji Arogya kendra, Malawadi Hadapsar Pune |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashwini Marotirao Pargewar |
Sane Guruji Arogya kendra Malawadi Hadapsar |
OPD no.4 Department of Swasthavritta,sane guruji Arogya kendra Malawadi Hadapsar pune Maharashtra
411028
Pune
MAHARASHTRA |
7620370491
ashupargewar271993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
perimenopausal syndrome |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bhramari Pranayama |
Bhramari Pranayama is the action of making a light humming sound while exhalation. for 8 Weeks; 4 sessions/week. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
women having clinical features of perimenopausal syndrome according to menopausal rating scale. |
|
| ExclusionCriteria |
| Details |
1.Subjects with known case of malignancy.
2.surgical menopause
3.subjects suffering from major systemic illness necessitating long term drug treatment
4.k/c/o rheumatoid arthritis,psycho-neuro-Endocrinol disorders
5.subjects with clinical evidence of heart failure. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A single arm clinical study to evaluate effectiveness of Bhramari Pranayama in Prevention of Perimenopausal syndrome.Parameter of efficacy will be Questionnaire according to Menopause Rating Scale. |
The treatment will be given for 60 days.Patients will be assessed on 15th day,30th day,45th day,60th day of the treatment.Total duration of the study will be 2 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome will be prevention of Menopausal Syndrome. |
The treatment will be given for 60 days.Patients will be assessed on 15th day,30th day,45th day,60th day.Total duration of the study will be 2 months. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
18/08/2021 |
| 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
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is Single Arm clinical study on effectiveness of Bhramari Pranayama for 60 days in Prevention of Perimenopausal Syndrome.The primary outcome will be prevention of Perimenopausal Syndrome. |