| CTRI Number |
CTRI/2024/06/068546 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical trail on Parangipattai chooranam in the management of Azhal keel vaayu (Osteoarthritis of Knee) 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 parangipattai chooranam in the management of azhal keel vaayu (osteoarthritis of knee) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S KAVIYA |
| Designation |
PG scholar |
| Affiliation |
Government Siddha Medical College and Hospital palayamkottai |
| Address |
Op number 10, PG department of Pothu Maruthuvam, Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai, Tirunelveli
Government Siddha Medical College and Hospital, Tiruvananthapuram main road, Palayamkottai 627002
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443722681 |
| Fax |
|
| Email |
kaviya17081998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Sathish kumar |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Op number 10, PG Department of Pothu Maruthuvam, Government Siddha Medical College and Hospital,Tiruvananthapuram main road,Palayamkottai
Tirunelveli.
Government Siddha Medical College and Hospital
Tiruvananthapuram main road
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9944337757 |
| Fax |
|
| Email |
drpsk_md@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr T Komalavalli Alias Mehala |
| Designation |
Head of the department |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Op number 10,PG department of Pothu Maruthuvam,Government Siddha Medical College and Hospital
Tiruvananthapuram main road
Palayamkottai
Tirunelveli
Government Siddha Medical College and Hospital,Tiruvananthapuram main road,Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9788122691 |
| Fax |
|
| Email |
komalaarumugam1@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 |
PG department of Pothu Maruthuvam,Government Siddha Medical College and Hospital,Tiruvananthapuram main road,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 |
| Kaviya S |
Government Siddha Medical College and Hospital |
PG department of Pothu Maruthuvam Government Siddha Medical College and Hospital
Tiruvananthapuram main road Palayamkottai
Tirunelveli
TAMIL NADU |
9443722681
kaviya17081998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL 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: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
PARANGIPATTAI CHOORANAM |
DOSAGE:1 to 3 gms,twice a day orally for 48 days with milk |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with Joint pain
2.Morning stiffness for less than 30 minutes
3.Crepitus on active movements
4.Joint line tenderness
5.Difficulty in Range of motion
6.Patient presenting with or without swelling |
|
| ExclusionCriteria |
| Details |
1. Patients with history of Trauma and post- trauma
2.Ligament tear
3.Patient undergone knee replacement surgery
4.Metabolic joint disease
5.Infectious joint disease(tuberculosis,polyarthritis)
6.Inflammatory arthritis(Rheumatoid arthritis)
7.Septic arthritis
8.Osteomyelitis
9.Chronic liver and renal diseases.
10.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 Azhal keel vaayu and to determine the effectiveness of parangipattai chooranam |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To collect various aspects of Azhal keel vaayu in Siddha literatures.
2.To evaluate physico chemical,phyto chemical and bio chemical characters of parangipattai chooranam.
3. To evaluate safety profile for assessing acute and sub-acute toxicity of trial drug parangipattai chooranam.
4.To evaluate pharmacological analysis of parangipattaichooranam.
5.Study about the prevalence of Azhal keel vaayu in relation between diet and life style.
6.To evaluate siddha parameters (including Envagai thervu) changes and dhegi in Azhal keel vaayu during the study period.
7. To evaluate modern parametric changes in Azhal keel vaayu.
8.To document the Bio statistical analysis.
9. To assess the Quality of life of azhal keel vaayu patients. |
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)
|
25/06/2024 |
| 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 Yet Recruiting |
| 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
|
This is A PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON- RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF PARANGIPATTAI CHOORANAM IN THE MANAGEMENT OF AZHAL KEEL VAAYU (OSTEOARTHRITIS OF KNEE). The trial drug PARANGIPATTAI CHOORANAM is freshly prepared and will be administered at the dosage of 1 to 3 gms ( Twice a day orally) with milk (pasum paal) as adjuvant for 48 days for 40 osteoarthritis of knee patients ( 20 OP & 20 IP patients). The primary outcome will be determining the effectiveness of PARANGIPATTAI CHOORANAM (INTERNAL) in the management of AZHAL KEEL VAAYU (OSTEOARTHRITIS OF KNEE). The secondary outcome will be to collect various Siddha literatures and modern journals for literature review on AZHAL KEEL VAAYU, to study other cofactors related to disease like age, sex, dietary habits, family history, and socioeconomic status, to perform physicochemical, phytochemical, bio chemical analysis of PARANGIPATTAI CHOORANAM, to evaluate safety profile for acute and sub-acute toxicity of -PARANGIPATTAI CHOORANAM, to evaluate pharmacological activities of PARANGIPATTAI CHOORANAM, to study about the prevalence of AZHAL KEEL VAAYU in relation with diet and lifestyle, to evaluate Siddha parameters (including Envagai thervu, Neerkuri-Neikuri) in AZHAL KEEL VAAYU during trial period, to evaluate DHEGI of AZHAL KEEL VAAYU patients, to evaluate modern parametric changes in AZHAL KEEL VAAYU, to assess the quality of life (QOL) of AZHAL KEEL VAAYU patients and to document Bio statistical analysis
|