| CTRI Number |
CTRI/2018/03/012861 [Registered on: 26/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
27/03/2018 |
| 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 panja lavana parpam(Internal),lahu vatha kesari thylam (External)on Azhal keel vayu(Osteo arthritis) |
|
Scientific Title of Study
|
An Open Clinical Study to evaluate the clinical efficacy of siddha sasthric formulation "PANJALAVANA PARPAM"(Internal)"LAHU VATHA KESARI THYLAM " for the treatment of AZHAL KEEL VAYU. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Nasiya Banu |
| Designation |
Pg student |
| Affiliation |
government siddha medical college |
| Address |
Department Of Pg Sirappu Maruthuvam
Government Siddha Medical College
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
|
| Fax |
|
| Email |
drnasiyaimthiyas@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr M Ahamed mohideen |
| Designation |
Assistant professor |
| Affiliation |
government siddha medical college |
| Address |
Department Of Pg Sirappu Maruthuvam
Government Siddha Medical College
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
|
| Fax |
|
| Email |
dr.ahmed63@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Nasiya Banu |
| Designation |
Pg student |
| Affiliation |
government siddha medical college |
| Address |
Department Of Pg Sirappu Maruthuvam
Government Siddha Medical College
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
|
| Fax |
|
| Email |
drnasiyaimthiyas@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD of government siddha medical college
Library of government siddha medical college
|
|
|
Primary Sponsor
|
| Name |
Dr S Neelavathi |
| Address |
Government Siddha Medical College and Hospital
Palayamkottai
Tirunelveli
|
| 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 M Nasiyabanu |
Government siddha medical and hospital |
Op No 4
Department of Pg Sirappu maruthuvam
Tirunelveli
TAMIL NADU |
9944506982
drnasiyaimthiyas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committeee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pain in both knee joints
swelling in knee
tenderness
stiffness in one are both knee joint
Crepitus
warmth
Restricted movement of joint
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
panja lavana parpam(Internal)
lahu vatha kesari thylam (External) |
panja lavana parpam1 kazhanju (5.1gram)with 1/4Perungayam + Honey (Internal)
lahu vatha kesari thylam (External)for 12 to 24 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.patients having symptoms of joint pain in one or both knee 2.joints,swelling,tenderness,stiffness,crepitation,restricted movements of joints.
3.patients who are willing to take x-ray before and after treatment.
4.patients who are willing to participate in this study with knowledge of potential risk. |
|
| ExclusionCriteria |
| Details |
1.systemic illness of the patient
2.Rhematoid arthritis
3.Use of narcotic drug
4.Pregnancy and lactation
5.History of trauma
6.Carcinoma patient
Tuberculosis
Immuno compromised patients
Clinically significant abnormal laboratory values
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction In Severity Of Joint Pain,Stiffness,And Improvement In Physical Functioning And Quality Of Life |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of siddha diagnostic parameters |
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)
|
03/08/2017 |
| 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) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Phase II
criteria based clinical study to evaluate the clinical efficacy of siddha herbo
mineral formulation of Panja lavana parpam 1 Kalanju (5.1Gram) Bd with ¼ Perungayam added to
Honey (Internal) and
lahu
vatha kesari thylam 30 ml (External) on Azal keel vayu(Osteo arthritis) for 48 days
in 40 patients during the trial period of 1 year 6 months that will be
conducted in government siddha medical college palyamkottai tamil nadu the
primary out come is reducing the clinical symptoms and increasing the range of
movements of trail drug Panja lavana parpam (Internal) and lahu vatha kesari thylam
(external) the secondary outcome will be the Evaluation of siddha diagnostic
parameters.
|