| CTRI Number |
CTRI/2019/08/020616 [Registered on: 07/08/2019] Trial Registered Prospectively |
| Last Modified On: |
06/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A STUDY OF AGNIKARMA(Therapeutic Cautery) AND MARMA CHIKITSA(Stimulation of vital points) IN THE MANAGEMENT OF FROZEN SHOULDER |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL EVALUATION OF AGNIKARMA AND MARMA CHIKITSA(MANIPULATION)IN THE MANAGEMENT OF APABAHUKA (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 |
VENKATA CHANDRAMOULI GURRAM |
| Designation |
MS(AYU) |
| Affiliation |
TTD SRI VENKATESWARA AYURVEDIC COLLEGE |
| Address |
TTD SRI VENKATESWARA AYURVEDIC COLLEGE
SVIMS CAMPUS
SHALYA TANTRA DEPARTMENT
OPD NO.3
TIRUPATI
ANDHRA PRADESH
TTD SRI VENKATESWARA AYURVEDIC COLLEGE
SVIMS CAMPUS
SHALYA TANTRA DEPARTMENT
OPD NO.3
TIRUPATI
ANDHRA PRADESH
517507
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
8142566443 |
| Fax |
|
| Email |
gvcmoulibams1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR M BHASKAR RAO |
| Designation |
MD PhD |
| Affiliation |
TTD SRI VENKATESWARA AYURVEDIC COLLEGE |
| Address |
TTD SRI VENKATESWARA AYURVEDIC COLLEGE
SVIMS CAMPUS
SHALYA TANTRA DEPARTMENT
ROOM NO.24
TIRUPATI
ANDHRA PRADESH
TTD SRI VENKATESWARA AYURVEDIC COLLEGE
SVIMS CAMPUS
SHALYA TANTRA DEPARTMENT
ROOM NO.24
TIRUPATI
517507
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9849147330 |
| Fax |
|
| Email |
drmbhaskarrao@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR M BHASKAR RAO |
| Designation |
MD PhD |
| Affiliation |
TTD SRI VENKATESWARA AYURVEDIC COLLEGE |
| Address |
TTD SRI VENKATESWARA AYURVEDIC COLLEGE
SVIMS CAMPUS
SHALYA TANTRA DEPARTMENT
ROOM NO.24
TIRUPATI
ANDHRA PRADESH
TTD SRI VENKATESWARA AYURVEDIC COLLEGE
SVIMS CAMPUS
SHALYA TANTRA DEPARTMENT
ROOM NO.24
TIRUPATI
ANDHRAPRADESH
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9849147330 |
| Fax |
|
| Email |
drmbhaskarrao@gmail.com |
|
|
Source of Monetary or Material Support
|
| TTD SRI VENKATESWARA AYURVEDIC COLLEGE AND HOSPITAL
SVIMS CAMPUS
TIRUPATI
517507
|
|
|
Primary Sponsor
|
| Name |
SRI VENKATESWARA AYURVEDIC COLLEGE |
| Address |
SVIMS CAMPUS
TIRUPATI
517507 |
| Type of Sponsor |
Private medical college |
|
|
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 GV CHANDRA MOULI |
SRI VENKATESWARA AYURVEDIC HOSPITAL |
SHALYA TANTRA DEPARTMENT
OP BLOCK
ROOM NO.3
Chittoor
ANDHRA PRADESH |
8142566443
gvcmoulibams1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TTD S.V.AYURVEDIC MEDICAL COLLEGE TIRUPATI ANDHRA PRADESH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M256||Stiffness of joint, not elsewhereclassified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Agnikarma |
PATIENT WILL BE TREATED WITH AGNIKARMA BY PANCHALOHA SHALAKA ON MAXIMUM TENDER POINTS ON THE AFFECTED SHOULDER JOINT FOR 3-5 SEC.
|
| Intervention |
Marma chikitsa |
PATIENT WILL BE TREATED BY PRESS AND RELEASE OF MARMA POINTS WITH FINGERS OF HAND ON AFFECTED SHOULDER JOINT AND FOREARM |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Pain & stiffness in the shoulder joint
2.Restricted range of motion
3.Patient willing for trial. |
|
| ExclusionCriteria |
| Details |
1.Fracture of affected hand
2.Any surgical implants in hand
3.Pregnant ladies
4.secondary diseases like Carcinoma,TB
5.Patient not willing for trial |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and evaluate the clinical efficacy of non-invasive techniques Marma chikitsa and Agnikarma in the management of Frozen shoulder |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Marma chikitsa and efficacy of Agnikarma |
4 weeks |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2019 |
| 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="1"
Days="30" |
|
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
|
Apabahuka,a disease of shoulder joint is very much similar to Frozen shoulder.Frozen shoulder is a common troublesome problem among the therapeutic disorders for both patients in terms of agony and orthopedicians in terms of its complex management.Although the disease is not fatal but its duration and attack of pain at night makes the life of sufferrer miserable and crippled.Marma therapy is the manipulation of subtle energy(prana) in the body for the purpose of supporting the healing process giving physical and psychological relaxation and finally strengthens the shoulder joint.
|