| CTRI Number |
CTRI/2021/11/037714 [Registered on: 01/11/2021] Trial Registered Prospectively |
| Last Modified On: |
29/10/2021 |
| 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 to study the effect of the drug Guru Parpam in the management of the patients having Polyarthritis(Santhu vatham) |
|
Scientific Title of Study
|
Phase II Non-Randomized Open Clinical Evaluation Of Siddha Medicine Guru Parpam For The Management Of Santhu Vatham (Polyarthritis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pavithra k |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department of General Medicine Government Siddha Medical College and Hospital Anna arch road NSK Nagar Arumbakkam
Chennai
TAMIL NADU
600106
India |
| Phone |
9944972987 |
| Fax |
|
| Email |
pavithrakannadasan222@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anbu N |
| Designation |
HOD and Professor |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department of General Medicine Government Siddha Medical College and Hospital Anna arch road NSK Nagar Arumbakkam
Chennai
TAMIL NADU
600106
India |
| Phone |
9443279412 |
| Fax |
|
| Email |
nanbu.sumi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pavithra k |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate Department of General Medicine Government Siddha Medical College and Hospital Anna arch road NSK Nagar Arumbakkam
Chennai
TAMIL NADU
600106
India |
| Phone |
9944972987 |
| Fax |
|
| Email |
pavithrakannadasan222@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College Anna arch road NSK Nagar Arumbakkam Chennai 600106 |
|
|
Primary Sponsor
|
| Name |
Government SIddha Medical College |
| Address |
Government Siddha Medical College Anna arch road NSK Nagar Arumbakkam Chennai 600106 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 Pavithra K |
Aringar Anna Government Hospital of Indian Medicine |
Room No 1 Siddha Department of Medicine Anna arch road NSK Nagar Arumbakkam Chennai 60006
Chennai
TAMIL NADU |
9944972987
pavithrakannadasan222@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M060||Rheumatoid arthritis without rheumatoid factor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guru Parpam |
488mg(1 Panavedai) of Guru Parpam is administered twice a day in ginger juice for 48 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Joint pain
Swelling
Stiffness
Tenderness
Restricted movements
Post viral arthritis
Seronegative RA |
|
| ExclusionCriteria |
| Details |
Pregnancy and lactating women
Rheumatic fever
Rheumatoid arthritis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary Outcome is mainly assessed by reduction in clinical symptoms measured by universal pain assessment scale |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary Outcome is mainly assessed by comparing the safety parameters before and after treatment |
48 days |
|
|
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)
|
10/11/2021 |
| 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
|
Not yet |
|
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 non randomised open clinical trial to study the safety and efficacy of siddha trial drug Guru Parpam.The Trial is given 488mg twicea day for 48 days. Clinical trial conducted after conducting Pre-clinical toxicity study. The trial drug Guru parpam is mentioned in Sarabendra vaidiya rathnavali .During the trial all the study related data will be recorded and documented. After the completion of the trial all the data will be analysed statistically. |