| CTRI Number |
CTRI/2023/05/053251 [Registered on: 30/05/2023] Trial Registered Prospectively |
| Last Modified On: |
11/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
An open labelled double arm non randomized phase II clinical trail, To evaluate the efficacy of Siddhar yoga Maruthuva muraigal and "VEPPAM PATTAI CHOORANAM" in the management of CEGANA VATHAM (CERVICAL SPONDYLOSIS) |
|
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 "VEPPAM PATTAI CHOORANAM" IN THE MANAGEMENT OF "CEGANA VATHAM "(CERVICAL SPONDYLOSIS)
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P KEERTHIKADEVI |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha medical college and hospital, palayamkottai |
| Address |
II year PG scholar Department of Siddhar yoga Maruthuvam,
Government Siddha medical college and hospital palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
6369206670 |
| Fax |
|
| Email |
drkeerthika94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A S POONGODI KANTHIMATHI MDS |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha medical college and hospital, palayamkottai |
| Address |
Department of Siddhar yoga Maruthuvam,Government Siddha
medical college and hospital, palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9865105356 |
| Fax |
|
| Email |
arunapriya1995@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A S POONGODI KANTHIMATHI MDS |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha medical college and hospital, palayamkottai |
| Address |
Department of Siddhar yoga Maruthuvam,Government Siddha
medical college and hospital, palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9865105356 |
| Fax |
|
| Email |
arunapriya1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and Government Siddha medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Dr P KEERTHIKADEVI |
| Address |
II year PG scholar Department of Siddhar yoga Maruthuvam
Government Siddha medical college and hospital palayamkottai
Tirunelveli-627002 |
| Type of Sponsor |
Other [SELF] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrPKeerthikadevi |
Government siddha medical college and hospital,Palayamkottai |
II year,Department of siddhar yoga maruthuvam,Government siddha medical college and hospital,Palayamkottai,
Tirunelveli 627002
Tirunelveli
TAMIL NADU |
6369206670
drkeerthika94@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M478||Other spondylosis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Siddhar yoga maruthuva muraigal with VEPPAM PATTAI CHOORANAM(Internal medicine) |
Yoga therapy for 48 days and veppam pattai chooranam 2 to 4 grams twice daily internally |
| Comparator Agent |
VEPPAM PATTAI CHOORANAM (Internal medicine) |
2 to 4 grams twice daily for 48 days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Neck pain
2.Radiating pain to upper limb
3.With or without numbness in the upper limb
4.Giddiness and neck stiffness
5.Patient who are willing for admission and stay in IPD or willing to attend OPD
6.Patient willing to sign informed consent document |
|
| ExclusionCriteria |
| Details |
1.Patients who face difficulties or hesitate to practice yoga are excluded
2.Patients with uncontrolled hypertension
3.Pregnancy and lactation
4.Tuberculosis in spine
5.Cardiac disease
6.Trauma,Fracture,Ligament injury within 6 months
7.Patient with any other serious systemic illness |
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Decreases the intensity of pain reduce swelling of joints |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
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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)
|
08/06/2023 |
| Date of Study Completion (India) |
16/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
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
|
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Brief Summary
|
It is an open labelled double arm non randomized phase II clinical trail To evaluate the efficacy of Siddhar yoga Maruthuva muraigal and VEPPAM PATTAI CHOORANAM in the management of CEGANA VATHAM.
VEPPAM PATTAI CHOORANAM
DOSAGE : 2 - 4 Gms twice daily
Along with Siddhar yoga Maruthuva muraigal |