| CTRI Number |
CTRI/2021/03/031777 [Registered on: 08/03/2021] Trial Registered Prospectively |
| Last Modified On: |
31/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study on siddhar yoga maruthuva muraigal and siddha medicine AVURI ILAI KUDINEER in management of AZHAL KEEL VAAYU (OSTEOARTHROTIS) |
|
Scientific Title of Study
|
An open labelled double arm non randomized phase II clinical trial to evaluate the efficacy of siddhar yoga maruthuva muraigal and siddha medicine AVURI ILAI KUDINEER in the management 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 |
Syed Rinos Fathima |
| Designation |
PG scholar |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Pg Siddhar yoga maruthuvam
Op number 4
Government siddha medical college and hospital
Palayamkottai
Pg Siddhar yoga maruthuvam
Op number 4
Government siddha medical college and hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8681057031 |
| Fax |
|
| Email |
syedrinos@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahalakshmi MDS |
| Designation |
Associate professor |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Department of Siddhar yoga maruthuvam
Op number 4
Government siddha medical college and hospital
Palayamkottai
Tirunelveli
Siddhar yoga maruthuvam
Op number 4
Government siddha medical college and hospital
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8248818479 |
| Fax |
|
| Email |
drmahalakshmi67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A S POONKODI KANDHIMATHI MDS |
| Designation |
professor |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Siddhar yoga maruthuvam
Op number 4
Government siddha medical college and hospital
Palayamkottai
Tirunelveli
Siddhar yoga maruthuvam
Op number 4
Government siddha medical college and hospital
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9865105356 |
| Fax |
|
| Email |
arunapriya1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and central library of Government siddha medical college and hospital, Palayamkottai |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college and hospital |
| Address |
Government siddha medical college and hospital
Palayamkottai
Tirunelveli
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 SYED RINOS FATHIMA Y |
Government siddha medical college and hospital |
op number 4
Department of siddhar yoga maruthuvam
Government siddha medical college and Hospital
Palayamkottoi
Tirunelveli
Tamilnadu
Tirunelveli
TAMIL NADU |
8681057031
syedrinos@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical commitee |
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 |
| Intervention |
Avuri ilai kudineer |
30ml twice a day/ 48days |
| Comparator Agent |
Siddhar Yoga Maruthuva Muraigal |
Pranayamam-20to80 cycle
Tadasanam
Utkatasanam
Pathrasanam
Padmasanam
Savasanam do twice a day |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having the symptoms of joint pain in one or both knee joints swelling tenderness stiffness crepitation restricted movement of joints
Patients who are willing to give radiological investigation and provide blood for lab investigation
Patients who are willing to participate in this study with the knowledge of potential risks and who are willing to sign the informed consent form
|
|
| ExclusionCriteria |
| Details |
• Rheumatoid arthritis
• cardiac disease
history of trauma
carcinoma
Tuberculosis
Patients with any other serious illness
Pregnancy women and lactating mothers
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The outcome of the study will be assessed by using the Universal Pain assessment scale
(before and after treatment)
|
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • The positive impact of Yoga in the treatment aspect may be highlighted through this study. |
48days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
09/03/2021 |
| Date of Study Completion (India) |
16/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study isAN OPEN LABELED DOUBLE ARM NON RANDOMIZED PHASE II CLINICAL TRIAL, TO EVALUATE THE EFFICACY OF SIDDHAR YOGA MARUTHUVA MURAIGAL AND SIDDHA MEDICINE "AVURI ILAI KUDINEER[INTERNAL]†IN THE MANAGEMENT OF AZHAL KEEL VAYU â€. The trial drug will be administrated at the dose of 30ml/ twice a day A/F 48 days in 40 patients. The trial period of 12 months will be carrying out in Government Siddha Medical College & Hospital, Palayamkottai, Tirunelveli, Tamil Nadu. ThePrimary Outcome: The study aims at bringing light on the Efficacy of the long standing traditional practice of Siddhar yogam therapy towards the management of Azhal keel vayu. It is expected that Siddhar yogam therapy along with AVURI illai kudineer will produce expected results in managing the problem of Azhal keel vayu. Secondary Outcome: The positive impact of Yoga in the treatment aspect may be highlighted through this study . In case of any adverse event (AE) is noticed and it will be referred to pharmacovigilance department of SCRI. Further management of patient will be given in OPD facility. |