| CTRI Number |
CTRI/2025/04/085897 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| 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 on Rashnadi Chooranam in the management of kumbavatham (Periarthritis) among patients attending OPD and IPD of Government Siddha Medical College and Hospital Palayamkottai
|
|
Scientific Title of Study
|
A prospective open labelled single arm non-randomized single centric
phase II clinical trial to determine the effectiveness of Rashnadi Chooranam in the management of
Kumbavatham(Periarthritis)
|
| 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 K S SUPRIYA |
| Designation |
PG SCHOLAR |
| Affiliation |
Government Siddha Medical College and Hospital,Palayamkottai |
| Address |
PG Department of Pothu Maruthuvam,
Government Siddha Medical College and Hospital Palayamkottai,Tirunelveli District,
Tamilnadu
Pincode:627002
India
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9489479200 |
| Fax |
|
| Email |
supriyaks1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S UMA KALYANI |
| Designation |
LECTURE GRADE II |
| Affiliation |
Government Siddha Medical College and Hospital,Palayamkottai |
| Address |
PG Department of Pothu Maruthuvam,
Government Siddha Medical College and Hospital Palayamkottai,Tirunelveli District,
Tamilnadu
Pincode:627002
India
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8072685509 |
| Fax |
|
| Email |
sukgsmc2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S UMA KALYANI |
| Designation |
LECTURE GRADE II |
| Affiliation |
Government Siddha Medical College and Hospital,Palayamkottai |
| Address |
PG Department of Pothu Maruthuvam,
Government Siddha Medical College and Hospital Palayamkottai,Tirunelveli District,
Tamilnadu
Pincode:627002
India
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8072685509 |
| Fax |
|
| Email |
sukgsmc2014@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and Central Library of Government Siddha Medical College and hospital Tiruvananthapuram main road palayamkottai Tirunelveli-627002 Tamilnadu India |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital |
| Address |
Government Siddha Medical College and Hospital,Palayamkottai,
Tirunelveli District
Pincode:627002
Tamilnadu
|
| 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 K S SUPRIYA |
Government Siddha Medical College and Hospital |
OP number 10 PG Department of Pothu Maruthuvam
Government Siddha Medical College and Hospital Tiruvanathapuram main road Palayamkottai Tirunelveli
627002 Tamilnadu India
Tirunelveli
TAMIL NADU |
9489479200
supriyaks1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITIEE GOVERNMENT SIDDHA MEDICAL COLLEGE PALAYAMKOTTAI |
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 |
RASHNADI CHOORANAM |
2 g twice a day after food orally with hot water 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 pain, numbness ,wasting in the shoulder region and arms, restricted movement of the upper limbs, loss of abduction &forward flexion, stiffness of the shoulder joint.
Diabetes mellitus |
|
| ExclusionCriteria |
| Details |
Age: below 29 to above 61 years
Rheumatoid arthritis
Ischaemic heart diseases
Pregnancy and lactating mother
Recent shoulders dislocation.
Recent shoulder fracture
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome will be aimed at reducing the symptoms of Kumbavatham(Periarthritis)and to determine the therapeutic efficacy of clinical trials drug(Rashnadi chooranam) |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Evaluation of additional effects and siddha parameters changes in kumba vatham
|
6 months |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/05/2025 |
| 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
|
N/A |
|
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 single arm non randomized single centric phase II non randomized clinical study to evaluate the therapeutic efficacy of RASHNADI CHOORANAM in the management of KUMBAVATHAM(PERIARTHRITIS).The trial drug will be administered at the dose of 2g twice a day orally after food for 45 days in 40patients.The trial period of 12 months will be carried out in Government Siddha Medical College and Hospital,palayamkottai,Tirunelveli,Tamilnadu.The primary outcome will be to determine the therapeutic efficacy of RASHNADI CHOORANAM in the management of KUMBAVATHAM (PERIARTHRITIS). |