| CTRI Number |
CTRI/2026/02/104158 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
10/05/2026 |
| 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 pirappan kizhangu kudineer in the management of uthiravatha suronitham (Rheumatoid Arthritis ) |
|
Scientific Title of Study
|
A prospective open labelled, single arm, non-randomized, single centric, phase II clinical trial to determine the effectiveness of PIRAPPAN KIZHANGU KUDINEER in the management of UTHIRAVATHA SURONITHAM (RHEUMATOID ARTHRITIS) |
| 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 R RAJA LAKSHMI |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital, Palyamkottai |
| Address |
OP number 10, PG Department Of Pothu Maruthuvam, Government Siddha Medical College And Hospital, Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
6380955354 |
| Fax |
|
| Email |
rajalakshmilakshmi839@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S JUSTUS ANTONY MD S |
| Designation |
Professor and Head of the department |
| Affiliation |
Government Siddha Medical College and Hospital, Palyamkottai |
| Address |
OP number 10, PG Department Of Pothu Maruthuvam, Government Siddha Medical College And Hospital, Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443090849 |
| Fax |
|
| Email |
justusantony71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S JUSTUS ANTONY MD S |
| Designation |
Professor And Head of the department |
| Affiliation |
Government Siddha Medical College and Hospital, Palyamkottai |
| Address |
OP number 10, PG Department Of Pothu Maruthuvam, Government Siddha Medical College And Hospital, Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443090849 |
| Fax |
|
| Email |
justusantony71@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD Facilities and Central Library
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli - 627002
Tamilnadu
India |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL |
| Address |
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli-627002
Tamilnadu
India |
| 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 R Raja Lakshmi |
Government Siddha Medical College and Hospital |
Department of Pothu Maruthuvam,Government Siddha Medical College and Hospital,Thiruvananthapuram road,Palayamkottai,Tirunelveli.
Tirunelveli
TAMIL NADU |
6380955354
rajalakshmilakshmi839@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL PALAYAMKOTTAI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Pirappan kizhangu kudineer |
60 ml twice a day orally for 48 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Pain and early morning stiffness more than one hour .
2.Those who are willing to participate in this study
3.RA Factor test positive
4.Anti CCP positive
5.CRP elevated
6.ESR elevated
|
|
| ExclusionCriteria |
| Details |
1.other degenerating joint diseases-osteoarthritis ,seronegative spondylo arthritis ,ankylosing spondylitis
2.Infectious joint diseases like tuberculosis,chronic poly arthritis in chickungunia viral infection
3.Metabolic joint diseases like gout .
4.patient who is on DMARD.(eg.methotrexate).
5.Pregnancy and lactating mother.
6.Chronic renal &liver diseases patients
7.Malignancy |
|
|
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 uthiravatha suronitham (Rheumatoid arthritis) and to determine the efficacy of Pirappan kizhangu kudineer. |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To collect various siddha literatures & modern journalsfor literature review on Uthiravatha suronitham.
2.To perform physicochemical, phytochemical, biochemical analysis of Pirappan kizhangu kudineer.
3.To evaluate the safety profile for acute toxicity of Pirappan kizhangu kudineer.
4.To evaluate pharmacological activities of Pirappan kizhangu kudineer.
5.To evaluate other cofactorsrealeated to disease like age,sex,dietary habits,family history,& socioeconomic status .
6.To evaluate siddha parameters (including envagaithervu) in Uthiravatha suronitham during trial period.
7.To evaluate modern parametric changes.
8.To assess the quality of life of uthiravatha suronitham.
9.To document bio statistical analysis.
|
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)
|
25/03/2026 |
| 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
Modification(s)
|
This is a prospective open labelled, single arm, non-randomized, single centric, PHASE II, clinical trial to determine the effectiveness of PIRAPPAN KIZHANGU KUDINEER in the management of UTHIRAVATHA SURONITHAM (RHEUMATOID ARTHRITIS). After purifcation of trial drug, Pirappan kizhangu kudineer will be prepared and administered at the dosage of 60ml twice a day orally for 48 days for 40 patients (20 OP and 20 IP patients). The primary outcome will be to evaluate the therapeutic effectiveness of siddha herbal Pirappan kizhangu kudineer in the management of Uthiravatha suronitham (Rheumatoid arthritis). The secondary outcome will be to collect various siddha literatures and ,modern journals for literature review of Uthiravatha suronitham, to perform physicochemical, phytochemical, biochemical analysis of Pirappan kizhangu kudineer,to evaluate safety profile for acute toxicity of Pirappan kizhangu kudineer, to evaluate pharmacological activities of Pirappan kizhangu kudineer,to study other co factors related to disease like age, sex, dietary habits, family history and socioeconomic status , to evaluate siddha parameters (including envagai thervu) for uthiravatha suronitham, to evaluate modern parametric changes, to assess the quality of life of uthiravatha suronitham patients, to document bio statistical analysis. |