| CTRI Number |
CTRI/2019/05/019142 [Registered on: 15/05/2019] Trial Registered Prospectively |
| Last Modified On: |
09/05/2019 |
| 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 to study the effect of trial drug sundii chooranam on kumbavatham (periarthritis) |
|
Scientific Title of Study
|
A Prospective open labelled non-randomized Phase II Clinical trial on SUNDII CHOORANAM in the management of KUMBA VATHAM (PERI ARTHRITIS) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Soundharya P |
| Designation |
PG student |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Op number 10 PG department of pothu maruthuvam Government siddha medical college and hospital palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9789798105 |
| Fax |
|
| Email |
paulsoundharya93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR A Manoharan MD PhD |
| Designation |
Professor and HOD |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Department of pothu maruthuvam Government siddha medical college and hospital palayamkottai Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR S Justus Antony |
| Designation |
Lecturer grade II |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Department of pothu maruthuvam Government siddha medical college and hospital palayamkottai Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443090849 |
| Fax |
|
| Email |
justusantony71@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPD and OPD of government siddha medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Govenment siddha medical college and hospital |
| Address |
Palayamkottai
Tirunelveli 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 |
| Soundharya P |
Govt siddha medical college and hospital |
Op number 10
PG department of pothu maruthuvam
Govt siddha medical college and hospital
Palayamkottai
Tirunelveli
TAMIL NADU |
9789798105
paulsoundharya93@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: M659||Synovitis and tenosynovitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIl |
| Intervention |
Sundii chooranam |
45mg/kg/BW/twice a day with hot water 45days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having main symptoms of shoulder joint pain restricted movement of upperlimbs loss of abduction and stiffness Diabetes mellitus Willing for doing lab investigation x-ray imaging |
|
| ExclusionCriteria |
| Details |
Age below 29 and above 61years Rheumatoid arthritis Ischaemic 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 ot the signs and symptoms of shoulder joint pain restricted movements of the upper limbs loss of abduction and forward flexion and stiffness of shoulder joint |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Achieving better oxford shoulder score (40-48) |
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)
|
16/05/2019 |
| 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="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is open labeled non randomized phase II clinical trial to evaluate the therapeutic efficacy of trial drug sundii chooranam 45mg/kg/BW two times a day with hot water for 45 days in 60 patients during the period of 14months that will be conducted in government siddha medical college and hospital palayamkottai tamilnadu |