| CTRI Number |
CTRI/2024/06/069486 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha
Other (Specify) [Varma Adangal murai] |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Plantar fasciitis is treated with Varma Adangal murai,Athimathura Chooranam and Ulunthumaa Poochu |
|
Scientific Title of Study
|
An open labelled triple arm non randomized phase II clinical trial,To Compare the Effectiveness of Varma Adangal murai and Athimathura chooranam (Internal) and Ulunthumaa poochu (External) in the Management of Kuthikaal vatham |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr THENMOZHI S |
| Designation |
PG SCHOLAR |
| Affiliation |
Government Siddha Medical College and Hospital Palayamkottai |
| Address |
PG Department of Varma Maruthuvam,
Government Siddha Medical College and Hospital,
Palayamkottai, Tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8754308416 |
| Fax |
|
| Email |
bsmshoney@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Muneeswaran |
| Designation |
Professor & HOD |
| Affiliation |
Government Siddha Medical College & Hospital, Palayamkottai. |
| Address |
PG Department of Varma Maruthuvam,
Government Siddha Medical College and Hospital,
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443724897 |
| Fax |
|
| Email |
ameswar1968@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Muneeswaran |
| Designation |
Professor & HOD |
| Affiliation |
Government Siddha Medical College & Hospital, Palayamkottai. |
| Address |
PG Department of Varma Maruthuvam,
Government Siddha Medical College and Hospital,
Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443724897 |
| Fax |
|
| Email |
ameswar1968@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD&IPD facilities, central library of Government Siddha Medical College and Hospital,Palayamkottai,
Tirunelveli-627002,
Tamilnadu,
India |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital |
| Address |
NO:2,langargana street,Government Siddha Medical College and Hospital Palayamkottai
Tirunelveli
TAMIL NADU
627002
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 |
| Dr THENMOZHI S |
Government Siddha Medical College and Hospital |
OPD no:14,IPD no:22&26,Department of Varma Maruthuvam,
Government Siddha Medical College and Hospital,
Palayamkottai
Tirunelveli-627002
Tirunelveli
TAMIL NADU |
8754308416
bsmshoney@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M722||Plantar fascial fibromatosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Athimathura chooranam-Internal.
Ulunthumaa poochu-External application.
|
Athimathura chooranam-1gm BD After food for 48 days.
Ulunthumaa poochu-applied over the affected area of the body for 48 days.
|
| Comparator Agent |
Nil |
Nil |
| Intervention |
Varma Adangal murai-External therapy.
|
External manipulation of Varma Adangal murai done by applying firm pressure for 21 days(1 to 7 days-daily,8 to 21 days-thrice a week).
|
| Intervention |
Varma Adangal murai-External therapy.
Athimathura chooranam-Internal.
Ulunthumaa poochu-External application.
|
External manipulation of Varma Adangal murai done by applying firm pressure for 21 days(1 to 7 days-daily,8 to 21 days-thrice a week).
Athimathura chooranam-1gm BD After food for 48 days.
Ulunthumaa poochu-applied over the affected area of the body for 48 days.
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
68.00 Year(s) |
| Gender |
Both |
| Details |
1.Talalgia
2.Arthritis
3.Bruising of Heel
4.Walking gait issues
5.Patient who are willing for admission and stay in IPD or Willing to attend OPD
6.Patient willing to sign the informed consent |
|
| ExclusionCriteria |
| Details |
1.Age Below 24 years and above 69 years
2.Fracture of the foot
3.Rupture of Achilles Tendon
4.Patient with any other serious systemic and chronic illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction of pain and improvement the movement of the affected ankle after
the treatment with trial drugs will be assessed by VAS Score
|
48 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
08/07/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
Modification(s)
|
It is an open labelled triple arm non randomized phase II clinical trial to compare the effectiveness of varma adangal murai and Athimathura chooranam (internal) and Ulunthumaa Poochu (external) in the management of Kuthikaal vatham. The dosage of internal medication Athimathura Chooranam is 1 gram (BD) and will be administered after food for 48 days. The external application of Ulunthumaa Poochu will be topically applied for 48 days. The manipulation of Varma Adangal murai will be done continuously for first one week and thrice a week for 8-21 days. The sample size for the study is 60 which will be categorized in to 3 groups of each 20. The first group will be given with Varma Adangal murai only. The second group will be given with internal medication along external application. The third group will be given with Varma Adangal murai,internal medication and external application. |