| CTRI Number |
CTRI/2024/08/072655 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive |
| Study Design |
Other |
|
Public Title of Study
|
An Observational Study On Siddha Diagnostic Methods with Line of Treatment, Dietary Regimen And Lifestyle Modification For Frozen Shoulder |
|
Scientific Title of Study
|
AN OBSERVATIONAL CLINICAL STUDY ON SIDDHA DIAGNOSTIC METHODOLOGY AND EXPLORATION OF LINE OF TREATMENT, DIETARY REGIMEN AND LIFESTYLE MODIFICATION FOR KUMBA VADHAM |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Saindhavi |
| Designation |
PG Scholar |
| Affiliation |
Govt Siddha Medical College and Hospital, Palayamkottai |
| Address |
Department of Noi Naadal,
Govt Siddha Medical College and Hospital,
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8778841301 |
| Fax |
|
| Email |
saindhavisyam168@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Sundararajan MDS |
| Designation |
Professor and HOD |
| Affiliation |
Govt Siddha Medical College and Hospital, Palayamkottai |
| Address |
Department of Noi Naadal,
Govt Siddha Medical College and Hospital,
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443423937 |
| Fax |
|
| Email |
soundsundar12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Sundararajan MDS |
| Designation |
Professor and HOD |
| Affiliation |
Govt Siddha Medical College and Hospital, Palayamkottai |
| Address |
Department of Noi Naadal,
Govt Siddha Medical College and Hospital,
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443423937 |
| Fax |
|
| Email |
soundsundar12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College and Hospital,
Palayamkottai,
Tirunelveli-627002,
Tamil Nadu.
|
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital Palayamkottai |
| Address |
Government Siddha Medical College and Hospital, Palayamkottai,
Tirunelveli 627002,
Tamil Nadu |
| 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 |
| Dr S Saindhavi |
Government Siddha Medical College and Hospital, Palayamkottai |
Room no 11
Government Siddha Medical College and Hospital, Palayamkottai
Tirunelveli
TAMIL NADU |
8778841301
saindhavisyam168@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with radiating pain in one side of the shoulder joint along the hand, severe pain and stiffness of shoulder join, weakness of the body,aggravations of pain during movements,Inability to bend or stretch hand, body tiredness and giddiness |
|
| ExclusionCriteria |
| Details |
Below 30 years and above 70 years of age,pregnancy and lactating women,Rheumatoid arthritis,recent shoulder fracture,recent shoulder dislocation. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the siddha diagnostic methodology especially Neerkuri,Naadi,Manikkadai nool can be used for KUMBA VADHAM |
1.5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the Line of treatment,Dietary regimen and Lifestyle modification for patients with KUMBA VADHAM |
1.5 years |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
30/08/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is designed to document the siddha diagnostic methodology and exploration of line of Treatment, dietary regimen and Lifestyle modification for the patients with KUMBA VADHAM - Periarthritis of shoulder joint. |