| CTRI Number |
CTRI/2026/02/104175 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
16/02/2026 |
| 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 on Anda Vayu Mathirai in the management of Kuthikaal Vatham (Plantar fasciitis) |
|
Scientific Title of Study
|
A prospective open labelled, single arm, non-randomized, single centric, phase II clinical trial to determine the effectiveness of Anda Vayu Mathirai in the management of Kuthikaal Vatham (Plantar fasciitis). |
| 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 Kanapathipillai Premaragavan |
| Designation |
PG Scholar |
| Affiliation |
Government siddha medical college and hospital |
| Address |
PG Department of Pothu Maruthuvam,Government Siddha Medical College and Hospital
Palayamkottai,Tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8220383084 |
| Fax |
|
| Email |
kanaprem87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Subash Chandran |
| Designation |
Professor |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
PG Department of Pothu Maruthuvam,Government Siddha Medical College and Hospital
Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443358271 |
| Fax |
|
| Email |
siddhadrgs21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Justus Antony |
| Designation |
Head of the Department |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
PG Department of Pothu Maruthuvam,Government Siddha Medical College and Hospital
Palayamkottai.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443090849 |
| Fax |
|
| Email |
justusantony71@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD facilities and central library of Government Siddha Medical College and Hospital,Palayamkottai,Tirunelveli–627002,India. |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College and Hospital |
| Address |
Government Siddha Medical College and Hospital,Palayamkottai,Tirunelveli -627002,Inida
|
| 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 Kanapathipillai Premaragavan |
Government Siddha Medical College and Hospital. |
Department Of Pothu Maruthuvam,Government Siddha Medical College and Hospital,Thiruvananthapuram Road,Palayamkottai.
Tirunelveli
TAMIL NADU |
8220383084
kanaprem87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Siddha Medical College, Palayamkottai,Tirunelveli – 627 002. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ANDA VAYU MATHIRAI |
Dosage- one pill (twice a day) After food for 45 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Ability to understand consent form for participation in
the study.
2.subjects having pain at least 2-6 VAS scale score ( confirmed through PFPS Plantar Fasciitis Pain,Scale)
3.Pain with palpation of the proximal insertion of the plantar fascia
4.Positive windlass test
|
|
| ExclusionCriteria |
| Details |
1.Previous Surgery on foot
2.Calcaneal Stress fracture
3.Tarsal Tunnel Syndrome
4.Heel Spurs
5.Pregnant women
6.Neurological disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The outcome will be aimed Clinical evidence support for the effect of ANDA VAYU MATHIRAI (INTERNAL) in the management of KUTHIKAL VATHAM (Plantar Fasciitis).
1.Pain Reduction of heel
-Reduced pain at initial weight-bearing
-Decreased pain during activities
-Pain reduced with palpation of the proximal insertion of the
plantar fascia
-Windlass test – Negative
2. It is expected to enhance a patient’s overall quality of life by reducing impact of the disease on their daily activities and emotional well being and overall heath |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To collects various siddha literatures and modern journals for literature review on KUTHIKAL VATHAM
To evaluate physicochemical, phytochemical, bio chemical, analysis of ANDA VAYU MATHIRAI.
To study about the prevalence of KUTHIKAL VATHAM in relation with diet and lifestyle
To evaluate the Pharmacological activities of ANDA VAYU MATHIRAI.
To evaluate siddha parameters (including Envagai thervugal)
To evaluate modern parametric changes in KUTHIKAL VATHAM
|
06 MONTHS |
|
|
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)
|
25/03/2026 |
| 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
|
This is a PROSPECTIVE OPEN LABELLED, SINGLE ARM, NON-RANDOMIZED, SINGLE CENTRIC, PHASE II CLINICAL TRIAL TO DETERMINE THE EFFECTIVENESS OF ANDA VAYU MATHIRAI IN THE MANAGEMENT OF KUTHIKAAL VATHAM (PLANTAR FASCIITIS).The trial drug ANDA VAYU MATHIRAI is freshly prepared and will be administered at a dosage one pill (twice a day orally) with hot water as adjuvant for 45 days 40 know KUTHIKAAL VATHAM (PLANTAR FASCIITIS) patients (20 OP&20 IP).The primary outcome will be determining clinical evidence support for the effect of ANDA VAYU MATHIRAI (INTERNAL) in the management of KUTHIKAL VATHAM (Plantar Fasciitis). The secondary outcome will be to collects various siddha literatures and modern journals for literature review on KUTHIKAL VATHM , To evaluate physicochemical, phytochemical, bio chemical, analysis of ANDA VAYU MATHIRAI ,To study about the prevalence of KUTHIKAL VATHAM in relation with diet and lifestyle ,To evaluate the Pharmacological activities of ANDA VAYU MATHIRAI ,To evaluate Siddha Parameters (including Envagai thervugal) ,To evaluate modern parametric changes in KUTHIKAL VATHAM. |