| CTRI Number |
CTRI/2021/07/035149 [Registered on: 27/07/2021] Trial Registered Prospectively |
| Last Modified On: |
26/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Varma thadaval for kumbavatham with varmam vatha ennai |
|
Scientific Title of Study
|
An open clinical trial on varmam thadaval (Varmam manipulation therapy) with varmam vatha ennai in the management of kumbavatham (Periarthritis 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 P S Devika |
| Designation |
BSMS |
| Affiliation |
National Institute of Siddha |
| Address |
Room no:3, Dept. of Varma maruthuvam, National Institute of Siddha, Tambaram sanatorium, Chennai 47
Dept. of Sirappu maruthuvam, National Institute of Siddha, Tambaram sanatorium, Chennai 47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
8129571306 |
| Fax |
|
| Email |
devika.p.s94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Mahalakshmi |
| Designation |
MD (S), PhD |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 3, Dept. of Varma Maruthuvam, National Institute of Siddha, Tambaram sanatorium, Chennai 47
Dept. of Sirappu Maruthuvam, National Institute of Siddha, Tambaram sanatorium, Chennai 47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9940668576 |
| Fax |
|
| Email |
rvmahalakshmi85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Mahalakshmi |
| Designation |
MD (S), PhD |
| Affiliation |
National Institute of Siddha |
| Address |
Room no 3, Dept. of Varma Maruthuvam, National Institute of Siddha, Tambaram sanatorium, Chennai 47
Dept. of Sirappu Maruthuvam, National Institute of Siddha, Tambaram sanatorium, Chennai 47
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9940668576 |
| Fax |
|
| Email |
rvmahalakshmi85@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Siddha, Tambaram Sanatorium, Chennai 47 |
|
|
Primary Sponsor
|
| Name |
PS Devika |
| Address |
National Institute of Siddha, Tambaram sanatorium, Chennai 47 |
| Type of Sponsor |
Other [Principal investigator] |
|
|
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 |
| PS Devika |
National Institute of Siddha |
Room no:3, Dept. of Varma Maruthuvam, National Institute of Siddha, Tambaram sanatorium, Chennai 47
Kancheepuram
TAMIL NADU |
8129571306
devika.p.s94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, (2) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Varma thadaval with Varmam vatha ennai |
Varma manipulation will be done once in a week for 15 - 20 minutes, for 49 days (7 sittings) |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with pain in the shoulder joint with or without radiated to arm, stiffness and restricted movement of shoulder joint. |
|
| ExclusionCriteria |
| Details |
Recent history of trauma, any other shoulder pathologies, unstable joint, hemiplegic shoulder joint, cervical radiculopathy, recent history of fracture and dislocation of shoulder, post surgical cases around shoulder, thoracic outlet syndrome, other musculoskeletal disorders. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| SPADI Scale. |
49 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Siddha diagnostic principles like envagai thervu, manikadai nool, neikuri |
49 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 3 |
|
Date of First Enrollment (India)
|
01/08/2021 |
| 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="5"
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)?
Response - NO
|
|
Brief Summary
|
This is a single arm open clinical study to evaluate the effect of varma manipulation methods with varmam vadha ennai in the management of Kumbavatham (Periarthritis shoulder). Patients will be included based on the inclusion and exclusion criteria. Defaulters will be withdraw from the study. Varma manipulation will be done for 15 - 20 minutes once in a week for 49 days, ie, 7 sittings. Outcome of the study will be assessed by using SPADI Scale. |