| CTRI Number |
CTRI/2020/08/027297 [Registered on: 21/08/2020] Trial Registered Prospectively |
| Last Modified On: |
20/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Marma massage therapy in frozen shoulder disease |
|
Scientific Title of Study
|
A Clinico-Anatomical study on Marma massage therapy on Amsa Marma in the management of Stabdhabahuta W.S.R to Frozen Shoulder |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhilasha |
| Designation |
MD Scholar |
| Affiliation |
University College of Ayurveda Jodhpur |
| Address |
Room no-53,PG Department of Rachana Sharir,University College of Ayurveda,Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9571500671 |
| Fax |
|
| Email |
choudharyabhi092@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyoram Sharma |
| Designation |
Assistant Professor |
| Affiliation |
University College of Ayurveda Jodhpur |
| Address |
Room no-53,PG Department of Rachana Sharir,University College of Ayurveda,Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9460724766 |
| Fax |
|
| Email |
shyoramsharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shyoram Sharma |
| Designation |
Assistant Professor |
| Affiliation |
University College of Ayurveda Jodhpur |
| Address |
Room no-53,PG Department of Rachana Sharir,University College of Ayurveda,Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9460724766 |
| Fax |
|
| Email |
shyoramsharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no-53,PG Department of Rachana Sharir,University College of Ayurveda,Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur RAJASTHAN 342037 |
|
|
Primary Sponsor
|
| Name |
Dr Abhilasha |
| Address |
Room no-53,PG Department of Rachana Sharir,University College of Ayurveda,Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur |
| Type of Sponsor |
Other [self] |
|
|
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 Shyoram Sharma |
Hospital Of University College Of Ayurveda Jodhpur |
OPD No 6, Panchkarma OPD,Hospital Of University College Of Ayurveda Jodhpur
Jodhpur
RAJASTHAN |
9460724766
shyoramsharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Greeva Basti |
Drug-Dashmool taila Duration-7 days Dose-150ml Route of administration - Local application |
| Intervention |
Marma Massage Therapy |
Drug-Dashmool taila
Route of administration -local application Dose- 5-10ml Duration of therapy-7 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having cardinal feature of Frozen shoulder, having shoulder pain, tenderness, restricted movement and motor weakness. |
|
| ExclusionCriteria |
| Details |
Patients having high blood sugar,traumatic injuries |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in subjective and objective criteria |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in subjective criteria with no associated complaints |
45 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
21/08/2020 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a randomised parallel group clinical trial of 30 patients which are divided into 3 groups .Each group consist of 10 patients. First group will be treated with Marma Massage therapy on Amsa Marma while the second group will be treated with Greeva Basti only. Third group wil be treated with both Marma Massage therapy as well as Greeva Basti. Therapy will be done for 7 consecutive days with follow up of 15 days. Patient will be examined and treatment will be given again after 15 days of follow up.
|