| CTRI Number |
CTRI/2023/09/057584 [Registered on: 13/09/2023] Trial Registered Prospectively |
| Last Modified On: |
13/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
Compare the Effectiveness of "Siddhar Yoga Therapy"and Internal "Amukkara karpam"In "Post Covid Myalgia". |
|
Scientific Title of Study
|
Phase II non randomized comparative open Clinical evaluation on "Post Covid myalgia"(vaatha soolai)treated with "Siddhar yoga therapy"and internal "Amukkara karpam" |
| Trial Acronym |
"Post Covid myalgia"(vaatha soolai)treated with "Siddhar yoga therapy"and internal "Amukkara karpam" |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Saibudeen |
| Designation |
Professor |
| Affiliation |
Govt Siddha Medical College. |
| Address |
NO.131,AP Plots 1ST Floor, 5th Street,
Anna Nagar, West extension
Chennai
Arumbakkam,
Chennai 600106.
Chennai
TAMIL NADU
600101
India |
| Phone |
9486041993 |
| Fax |
|
| Email |
drsaibudeen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Jeyaprakashnarayanan |
| Designation |
Chairman CCRAS/Professor |
| Affiliation |
SIddhalaya Clinic |
| Address |
No 31/2, Flowers Street,
Jegannatha Nagar,
Arumbakkam,
Chennai 600106.
No 31/2, Flowers Street,
Jegannatha Nagar,
Arumbakkam,
Chennai 600106
Chennai
TAMIL NADU
600 106
India |
| Phone |
8754423527 |
| Fax |
|
| Email |
Puthumaivinayagamjp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Saibudeen |
| Designation |
Professor |
| Affiliation |
Govt Siddha Medical College. |
| Address |
NO.131 AP plots 1ST Floor, 5th Street,
Anna Nagar West extension ,
Chennai.
Arumbakkam,
Chennai 600106.
Chennai
TAMIL NADU
600101
India |
| Phone |
9486041993 |
| Fax |
|
| Email |
drsaibudeen@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical College,Arumbakkam,Chennai - 600106 |
|
|
Primary Sponsor
|
| Name |
Govt Siddha Medical College. |
| Address |
Arignar Anna Hospital Campus,
Arumbakkam,
Chennai 600 106
|
| 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 |
| DrKSaibudeen |
Government Siddha Medical College Chennai |
Post graduate, Room
no S3, Department of
Siddhar Yoga
Maruthuvam,
Government Siddha
Medical
College,Arumbakkam,
Chennai.
Chennai
TAMIL NADU
Chennai
TAMIL NADU |
9486041993
drsaibudeen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE GOVT SIDDHA MEDICAL COLLEGE CHENNAI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amukkara chooranam with Yoga theraphy |
Amukkara chooranam powder form.
ASANAMS: Sedubandhasanam - 3 min,Tadasanam - 3mins,Sacasanam - 3mins.PRANAYAMAM:Nadisudhi pranayamam - 5mins.DHIYANAM:Aum chanting- 5 mins. Duration:48 days. |
| Comparator Agent |
Yoga Theraphy |
ASANAMS: Sedubandhasanam - 3 min,Tadasanam - 3mins,Sacasanam - 3mins.PRANAYAMAM:Nadisudhi pranayamam - 5mins.DHIYANAM:Aum chanting- 5 mins. Duration:48 days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient having any one of the Post Covid Symptoms of generalized or specific muscle pain, joint pain associated with muscle pain, and tenderness.
The patient has fatigue and tiredness.
The patient is willing to undergo the necessary investigation. |
|
| ExclusionCriteria |
| Details |
History of Fibromyalgia.
History of chronic myalgia.
Myopathy.
Auto-immune diseases.
Pregnant women and lactating mothers.
Patient with any other systemic severe illness.
Patient who are not affected with covid infection.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction of muscle pain/join pain,tenderness is assessed by VISUAL ANALOGUE SCALE.
Comparing the clinical symptoms and corresponding associated signs before and after treatment |
Reduction of muscle pain/join pain,tenderness is assessed by VISUAL ANALOGUE SCALE.
Comparing the clinical symptoms and corresponding associated signs before and after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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)
|
02/10/2023 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is An Open Labelled Non-Randomized Phase II Clinical Trial to Compare The Effectiveness of "SIDDHAR YOGA THERAPY" And INTERNAL "AMUKKARA KARPAM" for the management of "POST COVID SOOLAI" (POST COVID MYALGIA) in 48 Days. The Outcome will be measured by the VISUAL ANALOGUE SCALE and Reduced Symptoms.
|