| CTRI Number |
CTRI/2021/02/031214 [Registered on: 11/02/2021] Trial Registered Prospectively |
| Last Modified On: |
28/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial of Sathakuppai Chooranam in the management of Kumba vatham(Periarthritis) |
|
Scientific Title of Study
|
A Prospective Open labelled non randomized phase II Clinical trial of Sathakuppai Chooranam in the management of Kumba vatham(Periarthritis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S A Mathina Afrin |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam
Op no.10,
Government Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
7598745290 |
| Fax |
|
| Email |
afrinazeez62219@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Subashchandran MDs PhD |
| Designation |
Lecturer Grade II |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam,
Op no.10,
Government Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443358271 |
| Fax |
|
| Email |
siddhadrgs21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Subashchandran MDs PhD |
| Designation |
Lecturer Grade II |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam,
Op no.10,
Government Siddha Medical College and Hospital, Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443358271 |
| Fax |
|
| Email |
siddhadrgs21@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPD and OPD facilities and central library of Government Siddha Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital |
| Address |
Palayamkottai Tirunelveli Tamilnadu 627002 |
| Type of Sponsor |
Government 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 S A Mathina Afrin |
Government siddha medical college and hospital |
PG Department of
Pothu
Maruthuvam,
Op no.10,
Government Siddha
Medical College and
Hospital,
Palayamkottai.
Tirunelveli
TAMIL NADU |
7598745290
afrinazeez62219@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 |
Sathakuppai Chooranam |
1g Twice a day Orally after food with Sugar for 45 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having main symptoms of shoulder joint,numbness,wasting in the shoulder region and arms ,restricted movement of upper limbs,loss of abduction&forward flexion,stiffnees of the shoulder joint
Diabetes mellitus |
|
| ExclusionCriteria |
| Details |
Age below 29&above 61
Rheumatoid Arthritis
Ischemic heart Disease
Hypertension
Pregnancy and lactating mother
Recent Shoulder dislocation
Sub acromial bursitis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction of the signs and symptoms of shoulder joint pain
Numbness
Wasting in the shoulder region and arms
restricted movement of the upper limbs
loss of abduction
loss of forward flexion
stiffness of the shoulder joint |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of additional effects and siddha parameters changes in Kumba vatham |
45 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 |
|
Date of First Enrollment (India)
|
27/02/2021 |
| 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="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)?
Response - NO
|
|
Brief Summary
|
The study is a prospective Open Labelled phase II non randomized clinical study to evaluate the therapeutic efficacy of Sathakuppai Chooranam in the management of Kumba Vatham(Periarthritis).The trial drug will be administered at the dose of 1g twice a day orally aftert food for 45days in 60 patients.The trial period of 12 months will be carrying out in government Siddha Medical College And Hospital,Palayamkottai,Tirunelveli,Tamilnadu. |