| CTRI Number |
CTRI/2018/09/015828 [Registered on: 25/09/2018] Trial Registered Prospectively |
| Last Modified On: |
20/09/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of the effects of
a yoga procedure that is Brahmamudra and Anutaila Nasya in patient of cervical spondylosis |
|
Scientific Title of Study
|
Standard controlled trial of Brahmamudra and Anutaila Nasya in management of cervical spondylosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VdFarhatunnisa A AZIZ Syed |
| Designation |
M.D. (Scholar) |
| Affiliation |
P.D.E.A’S college of Ayurved & Research Center |
| Address |
Swasthavritta Department,
P.D.E.A’S College of Ayurved & Research Centre,
Akurdi,Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
7083786676 |
| Fax |
|
| Email |
drfarhat.yogayurved@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Deepali Jypal Manore |
| Designation |
ass.professor |
| Affiliation |
P.D.E.A’S college of Ayurved & Research Center |
| Address |
Swasthavritta Department,
P.D.E.A’S College of Ayurved & Research Centre,
Akurdi,Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9881650526 |
| Fax |
9881650526 |
| Email |
dr.manore@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VdFarhatunnisa A AZIZ Syed |
| Designation |
M.D. (Scholar) |
| Affiliation |
P.D.E.A’S college of Ayurved & Research Center |
| Address |
Swasthavritta Department,
P.D.E.A’S College of Ayurved & Research Centre,
Akurdi,Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
7083786676 |
| Fax |
|
| Email |
drfarhat.yogayurved@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurved Rasashala, karve road,near garware college pune |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 |
| VdFarhatunnisa A AZIZ Syed |
P.D.E.A. College for Ayurved and Research Centre |
swasthvritta department opd 123/B
Pune
MAHARASHTRA |
7083786676
drfarhat.yogayurved@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee College of Ayurved& Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BRAHMAMUDRA |
Neck rotation exercise (Brahmamudra) will be taught to volunteers and advised minimum 10-15 rotations in 10 min for 30 days |
| Comparator Agent |
Nasya |
Anutaila Pratimarsha Nasya. 1. 2 DROPS of Anutail Nasya will be advised daily for duration 30 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Prediagnosed cervical spondylosis patient.
2.Age group between 20 to 50 years irrespective of gender, cast or religion.
3.Patients ready to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Patient with congenital anomaly of spine
2.Patient with fracture or dislocation of cervical vertebrae and intervertibral disc
3.Patient of accidental cases
4.Patient with long term steroidal and hormonal treatment
5.Patient with fracture or dislocation of cervical spine, spondolylolythesis and any other anatomical deformities
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Mean change in Goniometry
2.Visual analogue scale
3.Neck pain disability index questionnaire |
Day 0 and Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse Event |
Day 0 and Day 30 |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/10/2018 |
| 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="0"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Standard controlled trial of Brahmamudra and Anutaila Nasya in management of cervical spondylosis. Total 60 patient of cervical spondylosis who will be attending Swasthrakshan OPD and IPD will be selected irrespective of gender, religion, economical status, education and occupation etc Participants will be selected from both sexes, age ranging between 20 to 50 years presenting with pain related to cervical spondylosis. The study shall have two arms viz. Brahmamudra and arm Anu tail Nasya arm. 2 DROPS of Anutail Nasya will be advised daily for 30 days to Group A and 10-15 rotation of Brahmamudra will be advised daily for duration of 30 days to Group B.
Assessment shall be done as per Visual Analogue Scale (VAS) and Neck pain disability index questionnaire and Range of cervical movement by goniometry.
|