| CTRI Number |
CTRI/2018/05/013919 [Registered on: 16/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
12/05/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Nasal drops of medicated oil and Specific Exercises are helpfull in Frozen sholder |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE ROLE OF NASYA AND PHYSIOTHERAPY IN THE MANAGEMENT OF AVABAHUKA 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 |
SHRIJA MAVANI |
| Designation |
MD |
| Affiliation |
IPGT AND RA JAMNAGAR |
| Address |
304, PG LADIES HOSTEL IPGT AND RA, JAMNAGAR
DEPARTMENT OF PANCHAKARMA
IPGT AND RA JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
9737988065 |
| Fax |
|
| Email |
drshreejamavani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anup Thakar |
| Designation |
H.O.D. Panchakarma |
| Affiliation |
IPGT AND RA JAMNAGAR |
| Address |
406,Department of Panchakarma, IPGT and RA, Jamnagar.
Director
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
91-288-2555966 |
| Email |
anup_thakar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
SHRIJA MAVANI |
| Designation |
MD |
| Affiliation |
IPGT AND RA JAMNAGAR |
| Address |
304 PG LADIES HOSTEL IPGT AND RA JAMNAGAR
DEPARTMENT OF PANCHAKARMA
IPGT AND RA JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
9737988065 |
| Fax |
|
| Email |
drshreejamavani@gmail.com |
|
|
Source of Monetary or Material Support
|
| GUJARAT AYURVEDA UNIVERSITY, Jamnagar, Gujarat. |
|
|
Primary Sponsor
|
| Name |
GUJARAT AYURVED UNIVERSITY |
| Address |
DEPARTMENT OF PANCHAKARMA
IPGT AND RA
JAMNAGAR |
| 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 |
| SHRIJA MAVANI |
IPGT AND RA HOSPITAL |
OPD NO 22, PANCHAKARMA DEPARTMENT
Jamnagar
GUJARAT |
9737988065
drshreejamavani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE IPGT AND RA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients who are suffering from symptoms of AVABAHUKA , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Masha Taila for Nasya and stretching exercises for physiotherapy |
Masha Taila for Nasya Karma 8 drops in each nostril for 3 week with the gape of 3 days after 1 week. Various Stretching exercises explained to patients how to perform themselves. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with classical signs and symptoms of Avabahuka like restricted movement of shoulder joint, painful movement of shoulder joint
2.Patients within the Age group of 18 to 60 years.
3.Patients fit for Nasya karma.
|
|
| ExclusionCriteria |
| Details |
1.Patients below 18 years and above 60 years of age.
2.Patients of shoulder joint dislocation/fracture.
3.Unfit for Nasya karma.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PATIENTS WILL GET RELIEF FROM SIGN AND SYMPTOMS OF AVABAHUKA |
After 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| OTHER THEN AVABAHUKA PATIENTS WILL ALSO GET RELIEF FROM SYMPTOMS |
2 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/02/2017 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
study will be conducted as conseptual,clinical trial. |