| CTRI Number |
CTRI/2019/06/019893 [Registered on: 27/06/2019] Trial Registered Prospectively |
| Last Modified On: |
22/06/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of ayurveda in frozen shoulder |
|
Scientific Title of Study
|
To Evaluate And Compare The Effectiveness Of Integrated Approach Panchakarma And Physiotherapy In Frozen Shoulder. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepti Bagewadi |
| Designation |
Assistant professor Department of Panchakarma |
| Affiliation |
KAHER’s Shri BMK Ayurveda Mahavidyalaya |
| Address |
OPD No 04 and IPD of KLE Ayurveda Hospital Shahapur Belgaum 590003
Belgaum
KARNATAKA
Belgaum
KARNATAKA
590003
India |
| Phone |
9964608727 |
| Fax |
|
| Email |
deeptibagewadi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepti Bagewadi |
| Designation |
Assistant professor Department of Panchakarma |
| Affiliation |
KAHER’s Shri BMK Ayurveda Mahavidyalaya |
| Address |
OPD No 04 and IPD of KLE Ayurveda Hospital Shahapur Belgaum 590003
Belgaum
KARNATAKA
Belgaum
KARNATAKA
590003
India |
| Phone |
9964608727 |
| Fax |
|
| Email |
deeptibagewadi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepti Bagewadi |
| Designation |
Assistant professor Department of Panchakarma |
| Affiliation |
KAHER’s Shri BMK Ayurveda Mahavidyalaya |
| Address |
OPD No 04 and IPD of KLE Ayurveda Hospital Shahapur Belgaum 590003
Belgaum
KARNATAKA
Belgaum
KARNATAKA
590003
India |
| Phone |
9964608727 |
| Fax |
|
| Email |
deeptibagewadi@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belgaum 590003 |
|
|
Primary Sponsor
|
| Name |
KAHERs Shri B M K Ayurveda Mahavidyalaya |
| Address |
KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belgaum 590003 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepti Bagewadi |
KLE Ayurveda Hospital |
OPD No 04 and IPD of KLE Ayurveda Hospital Shahapur Belgaum 590003
Belgaum
KARNATAKA
Belgaum
KARNATAKA |
9964608727
deeptibagewadi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagaum 590003 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M799||Soft tissue disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Integrated |
Stanikaabhyanga with
Ksheerabalataila 30ml externally for 7 days, Nasya with Anutaila 16 drops in each nostrils for 7 days, Patrapindasweda 2 pottali externally for 7 days, Interferential therapy –
15 mins foe 7 days, Mobilization - 20mins for 7days |
| Comparator Agent |
Panchakarma |
Stanikaabhyanga with Ksheerabalataila 30ml externally for 7 days, Nasya with Anutaila 16 drops in each nostrils for 7 days, Patrapindasweda 2 pottali externally for 7 days |
| Comparator Agent |
Physiotheraphy |
Interferential therapy – 15 mins foe 7 days, Mobilization - 20mins for 7days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with signs and symptoms of frozen shoulder were selected irrespective of their religion, sex, occupation, and socio economic status,
Age group 20-60yrs
All subjects with unilateral or bilateral pain in the shoulder.
|
|
| ExclusionCriteria |
| Details |
Patients k/c/o fracture or dislocation of cervical region.
Patients with k/c/o major systemic disorders that interfere with the course of treatment were excluded from the study.
K/c/o neoplastic condition of spine were excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Integrated protocol will be effective in treating Frozen
shoulder. |
1st, 8th, 15th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/01/2020 |
| 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="2"
Months="0"
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
|
Study is being
conducted with the objective of evaluating the combined effect of treatment
(Panchakarma and Physiotherapy) it was observed that individual treatments have
good results in patients so this study is being taken up to observe if combined
therapy would give better results. |